Clinical OMICs

Clinical OMICsVol. 8, No. 1 Rapid SARS-CoV-2 testingRapid SARS-CoV-2 testing: LAMP and antigen COVID-19 tests promise inexpensive, accurate, and fast results to help manage the pandemicHelen AlbertHelen AlbertSearch for more papers by this authorPublished Online:11 Feb 2021https://doi.org/10.1089/clinomi.08.01.18AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookXLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 1Jan 2021 InformationCopyright © GEN PublishingTo cite this article:Helen Albert.Rapid SARS-CoV-2 testing: LAMP and antigen COVID-19 tests promise inexpensive, accurate, and fast results to help manage the pandemic.Clinical OMICs.Jan 2021.14-18.http://doi.org/10.1089/clinomi.08.01.18Published in Volume: 8 Issue 1: February 11, 2021PDF download

Clinical OMICsVol. 8, No. 1 Human Genome Project at 20Human Genome Project at 20: Despite advances in understanding the genetic underpinning of many diseases, roadblocks to therapeutic development remainAnjali SarkarAnjali SarkarSearch for more papers by this authorPublished Online:11 Feb 2021https://doi.org/10.1089/clinomi.08.01.27AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 1Jan 2021 InformationCopyright © GEN PublishingTo cite this article:Anjali Sarkar.Human Genome Project at 20: Despite advances in understanding the genetic underpinning of many diseases, roadblocks to therapeutic development remain.Clinical OMICs.Jan 2021.36-41.http://doi.org/10.1089/clinomi.08.01.27Published in Volume: 8 Issue 1: February 11, 2021PDF download

Clinical OMICsVol. 8, No. 3 NewsFree AccessOrchid Launch Stirs Up PRS Debate: The company has begun marketing to consumers its PRS-based preconception test expected to be available later this yearMalorye Allison Branca, Contributing EditorMalorye Allison Branca, Contributing EditorSearch for more papers by this authorPublished Online:18 Jun 2021https://doi.org/10.1089/clinomi.08.03.17AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail Startup Orchid is launching the first preconception test that the company contends predicts a couple's chances of conceiving a child with high risk of common illnesses, such as heart disease, stroke, schizophrenia, and several types of cancer. The test applies whole-genome sequencing (WGS) to a saliva sample from each partner, and is based on polygenic risk scores (PRSs), rather than the standard carrier-type of test for single-gene, or monogenic, mutation screening for hereditary disorders. The company says it plans to offer similar PRS-based WGS testing for IVF-generated embryos soon as well.Although the seed round of financing is a modest $4.6M, the investors include high profile names, such as: 23andMe's Anne Wojcicki; co-founder of Counsyl and former general partner at Andreessen Horowitz, Balaji Srinivasan; co-founder, former CEO of Flatiron health Nat Turner; and MacArthur award-winning Stanford geneticist Carlos D. Bustamante. Notably, 23andMe paved the pathway for medically-related direct-to-consumer product approval.Orchid believes prospective parents will find value in their test that provides a “couples report” of genetic disease risk of their offspring.This is a new angle in a thriving market. Non-invasive prenatal testing (NIPT) is set to reach more than $10 billion over the next few years, besides monogenic diseases it covers common aneuploidies. On its own, carrier testing, which typically screens just for heritable genetic diseases, is expected to exceed $1.3 billion. Most of the growth in the carrier and NIPT testing is generated by more thorough single-gene disorder testing and geographic expansion.Currently, carrier screening is used mostly by people with a family history of illness to find out if they have a high risk of passing on severe conditions such as cystic fibrosis, sickle cell disease, or spinal muscular atrophy. Most often carrier testing involves just one or a few tests, and is relegated to the leading rare diseases or to people, such as Ashkenazi Jews, whose ethnicity puts them at particular risk for certain inherited conditions.But the push to offer screening for a larger number of disorders has accelerated. LabCorp's Integrated Genetics, for example, offers screening for one-to-500 heritable genetic diseases. And as these panels have expanded, a wider array of patients have started using them.There's science supporting wider testing. For example, Myriad, through its 2018 acquisition of Counsyl, gained a foothold in expanded carrier screening (ECS). In a 2020 paper in Genetics in Medicine, Myriad researchers reported that in a study of more than 93,000 people “Self-reported ethnicity was an imperfect indicator of genetic ancestry, with 9% of individuals having more than 50% genetic ancestry from a lineage inconsistent with self-reported ethnicity. Limitations of self-reported ethnicity led to missed carriers in at-risk populations.”Myriad says its exome-based Foresight 176-condition ECS panel can identify 30% more carriers of cystic fibrosis than typical tests and offers a 99% detection rate for Alpha Thalassemia across ethnicities.Sema4 also offers ECS based on exome sequencing. Their Sema4 ECS screen detects up to 280 diseases, with sequencing technology the company describes as “99% accurate.” They also see potential for expansion. “Looking forward, we could foresee that, when applied across the whole genome, this industry could potentially realize near 95% detection rate on thousands of genes. Advances in RNA sequencing in studies of germline cancer will evolve to contribute to increased understanding in carrier screening as well,” says Bridget Winders, SVP and general manager, Women's Health, Sema4.So, for now it seems to be a numbers game, who can offer the most coverage with the greatest accuracy across the most ethnicities.Orchid's gamble is on whether parents will pay up to take the additional step of finding out how their genetics could influence their future offspring's risk of common diseases. It also brings PRS testing, which is slowly entering the clinic, further into the already booming prenatal testing field, which is expected to grow at a CAGR of more than 13% per year for the next few years.“This is not for the rare genetic diseases,” Noor Siddiqui, Orchid founder and CEO told Clinical OMICs. “These are the most common health conditions and we are aggregating millions of data points about every risk.” The company says its test is based on six billion data points, from published studies, and those will be added to and updated as new data is gathered in the now rapidly-moving field of genetic risk score assessment.One of the references Orchid cites is Khera, A.V. et al's 2018 Nature Genetics paper “Genome-Wide Polygenic Scores for Common Diseases Identify Individuals with Risk Equivalent to Monogenic Mutations.” These authors developed and validated genome-wide polygenic scores for five common diseases. They reported that their approach identified 8.0%, 6.1%, 3.5%, 3.2% and 1.5% of the population at greater than three-fold increased risk for coronary artery disease (CAD), atrial fibrillation, type 2 diabetes, inflamma-tory bowel disease, and breast cancer, respectively.PRS in the clinicThe hope is that PRS scores will allow clinicians in to use genomic sequence information for more than just diagnosing chromosome abnormalities and rare diseases.The key question is whether this approach is ready for application in this particular market. Specialists in PRS have expressed skepticism about healthy parents using such a tool, since these scores provide a relative risk, rather than an absolute risk score. The data sets used are so non-specific that it can be difficult to narrow down their implications, even with input from experts. A common complaint is that they are not yet large enough to cover a wide range of ethnicities, but there are other problems.‘We don't have large enough data sets to have confidence in these scores in many applications,” says Nicholas Schork, Ph.D., deputy director and Distinguished Professor of Quantitative Medicine at the Translational Genomics Research Institute (TGen). “To use these properly you need to know other data, such as a patient's medical history and age.” For example, someone who is elderly, has smoked all their lives, and has an elevated cholesterol level will likely have a different risk level than a much younger person with the same PRS score.The UK Biobank, he notes, has data from more than 400,000 individuals. These include more than 20,000 cancer cases and it recently published a study showing that a PRS with family history “measurably improves prediction accuracy for most cancers, but the magnitude of this improvement varies substantially.” (Kachuri, L., et al. Nature Communications, November 2020).However, he also points to Myriad Genetics' MyRisk test for women who have a family history of breast cancer but have tested negative for BRCA1 or BRCA2. Myriad famously pioneered the first commercial test to identify carriers of mutations in these two genes, which are linked to hereditary cancer. The company's MyRisk panel was first launched in 2013 as a 25-gene panel to identify elevated risks for eight hereditary cancers. It currently includes mutations in 35 genes and is available to people of all ancestries.Thomas Slavin, M.D., says “Myriad is in the process of presenting data at ASCO that further validates the company's PRS in breast cancer, called riskScore, across all major ancestries.” Slavin is senior vice president of Oncology at Myriad.Thomas Slavin, M.D., senior vice president, Oncology, Myriad GeneticsAnother expert with reservations is, Genevieve L. Wojcik, Ph.D., assistant professor at the Johns Hopkins Bloomberg School of Public Health. Wojcik was a post-doc in Bustamante's lab and is the senior author on a recent (March 2021) landmark paper in Nature on improving reporting standards for polygenic scores in risk prediction studies.Genevieve L. Wojcik“Out-of-the-box, a lot of these scores are not as clinically useful as people think they are,” says Wojcik. “I do not think carrier testing or embryo selection is the right application for PRS scores at this time.” Since the calculations involve two parents, and the embryo's risk is a range, that's not very useful information, she says.But help is on the way. Clinical trials are being pursued and the paper on PRS standards that Wojcik co-authored was a collaboration between the Clinical Genome Resource (ClinGen), the ComplexDisease Working Group, and the Polygenic Score (PGS) Catalogue.That publication presents standards for PRS score reporting. The authors note that the weighted sums of allele counts used to estimate a risk of a trait or disease for a PRS can include millions of variants, so a structured format in publishing these is crucial. They point out that more than 900 publications mentioning PGS or PRS have been published in the last decade. Reporting standards, they write, could “boost predictive performance” of these scores.At least one company, Genomic Prediction, is offering PGS-based testing for embryos. Its LifeView PGT-P test identifies an embryo's lifetime risk of developing conditions including schizophrenia, type 1 or type 2 diabetes, several causes of heart disease, and a variety of cancers including basal cell carcinoma, malignant melanoma, and breast or prostate cancer. But this is clearly just the beginning for PRS in prenatal testing, and clinical use overall.It's not clear whether the Orchid test will be direct-to-consumer or, like most carrier tests, will require a physician's sign off. The company is marketing to consumers, and inviting them to join its wait list. It's notable, however, that one of Orchid's investors is Anne Wojcicki, a co-founder of 23andMe. Her company has been one of the few, if the only, that has stayed the course in getting FDA approval for direct-to-consumer medical tests.After a flurry of DTC genomic tests were launched, FDA put the brakes on the field in 2010. But with diligence and evidence from 23andMe, by 2017 the agency announced that it had allowed that company to market the “first direct-to-consumer tests that provide genetic risk information for certain conditions.” Those conditions include Parkinson's disease, late-onset Alzheimer's, celiac, Gaucher type 1, and several others.A 23andMe spokesperson says the company's offerings include some PRS, including some wellness reports such as the Type 2 Diabetes Report within their Health Predisposition category. “These reports are developed and validated completely on 23andMe research data,” the spokesperson said. “They fall under the FDA's enforcement discretion.”An Orchid spokesperson says their test is, “…a patient initiated, physician ordered test, results are reviewed and released with a board certified genetic counselor.” While the FDA will neither confirm nor deny if an application is in process, the Orchid spokesperson says that tests like this one are classified as laboratory developed tests (LDTs).”Skeptics aboundWhile the Orchid preconception test may be attractive to patients, the company still faces many skeptics, especially for its use among healthy would-be parents.“For prenatal testing, this is still very controversial,” says Schork. “It's very unlike evaluating a 40-year-old where you have other data. And then there are a really deep set of issues relating to the whole idea of creating ‘super embryos'.” He adds that this is a disruptive technology and medical education will need to step up to meet the demands it creates to make it truly useful for patients.Julian Savulescu, a professor in Philosophy at the University of Oxford, says, “For IVF, it's reasonable to use whatever means you have to select the healthiest embryo, in fact, it can be seen as a moral obligation,” he says. “Afterall, if you have only 10 embryos and are choosing one, you just have to do better than chance in making that selection.” Natural reproduction, Savulescu points out is relatively inefficient. “One-out-of-five fertilized eggs go on to produce an embryo, and 5% of babies have some chance of having an abnormality.”Julian Savulescu, Ph.D., professor in Philosophy, University of OxfordBut it is a separate question whether you should do this type of testing if you are not at risk of having any of these diseases and you are not doing IVF,” he adds. “The accuracy and reliability is just not there yet.”Nonetheless, Savulescu sees the use of such tests as “Becoming more and more common.” After all, he points out, “If parents want to use it, why shouldn't they?”The Orchid Couple Report LaunchedOrchid's test aims to provide even people without a family history of disease a means to determine their future off-spring's likelihood of serious common ailments. The test requires only a mailed-in saliva sample from each prospective parent, and is based on genetic risk scores calculated by testing for genetic variations. Its “Couple Report” reveals if either partner is at elevated risk of passing on 10 diseases: heart disease, stroke, atrial fibrillation, schizophrenia, Alzheimer's Disease, breast cancer, prostate cancer, type 2 diabetes, type 1 diabetes, and inflammatory bowel disease.The report comprises data from both partners' whole genomes and models of how that DNA could combine in a child, providing simulations of both the lower-and higher-likelihood scenarios. If the result is a “high likelihood” for one of more conditions, there are genetic counselors on hand and advice available about how to mitigate whatever disease is involved.Orchid's leadership emphasize that one of most prospective parents' key concerns is their children's health.“Up until now, parents could only genetically screen for the rare events with a one-in-1,000 or even one-in-a-million chance of happening. Yet there was no way for prospective parents to measure their future child's genetic predispositions to much more common chronic, debilitating diseases based on their combined genetics alone,” said Orchid advisor Jacques Cohen, Ph.D., in a press release, adding that “Orchid now makes this at-home test a reality.”Noor Siddiqui, founder, OrchidCohen is director of the ART Institute of Washington, which runs the joint National Institute of Health and Walter Reed National Military Medical Center IVF program. He was a founder of Reprogenetics, now called Cooper Genomics, and other reproductive science-related firms.There is evidence supporting their claim. Over the last few years, the market for prenatal testing has grown dramatically. Further, a March 2019 survey of just over 800 pregnant women in Obstetrics and Gynecology found that when it came to prenatal testing “Respondents generally preferred to receive all categories of genetic results pertaining to medical conditions.”A typical preconception genetic screening, Siddiqui said, analyzes only 2% of just one partner's genome and is only capable of detecting rare genetic disorders affecting approximately 1% of the population. By contrast, Orchid analyzes the entirety of both partner's genomes and assesses genetic predispositions to diseases that affect more than 60% of the population.For couples who find they are at elevated risk based on Orchid's test, one strategy is to elect to pursue IVF and have further analyses of their embryos. Later this year, Orchid plans to launch an Embryo Report that will provide genetic risk information related to IVF embryos.Investors in the seed round include Refactor Capital, Village Global, Day One Ventures, Olive Capital, and Boom Capital. The round also includes participation from the founders of 23andMe, Counsyl, Clover Health, Coinbase, Eventbrite, Flatiron, Oscar Health Insurance, and Stellar.Skeptics abound, but startup Orchid believes there is a market for their pre-conception testing product for parents that uses polygenic risk scores to indicate the future risk of their children developing common ailments such as heart disease, stroke, schizophrenia, and several types of cancer.“Having children is the most consequential choice most of us make, yet parents go into pregnancy with zero visibility into how genetic risks could impact their future child,” said Siddiqui. “With Orchid's ultra-high-resolution reports, prospective parents can now conceive with confidence, prepared with information and guidance to give their children a better chance at a healthy life.”Orchid is now inviting couples to join a waitlist to get early access to Orchid's Couple Report. Each test provides a risk-analysis report for each partner as well as an estimate of their potential offspring's risk. Along with their report, couples also receive health and wellness guidance from professionals including genetic counselors and fertility experts as part of the service. That includes advice on how to prevent or mitigate any risks detected.FiguresReferencesRelatedDetails Volume 8Issue 3May 2021 InformationCopyright © GEN PublishingTo cite this article:Malorye Allison Branca, Contributing Editor.Clinical OMICs.May 2021.10-14.http://doi.org/10.1089/clinomi.08.03.17Published in Volume: 8 Issue 3: June 18, 2021PDF download

Clinical OMICsVol. 8, No. 4 NewsGreen Light Raises Red Flags: FDA, some experts at odds over agency's accelerated approval for Aduhelm, the Alzheimer's disease drug from Biogen and EisaiAlex Philippidis, Senior News EditorAlex Philippidis, Senior News EditorSearch for more papers by this authorPublished Online:26 Aug 2021https://doi.org/10.1089/clinomi.08.04.18AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 4Jul 2021 InformationCopyright © GEN PublishingTo cite this article:Alex Philippidis, Senior News Editor.Green Light Raises Red Flags: FDA, some experts at odds over agency's accelerated approval for Aduhelm, the Alzheimer's disease drug from Biogen and Eisai.Clinical OMICs.Jul 2021.12-14.http://doi.org/10.1089/clinomi.08.04.18Published in Volume: 8 Issue 4: August 26, 2021PDF download

Clinical OMICsVol. 8, No. 6 NewsTOP PRECISION MEDICINE HEALTH SYSTEMSPioneers in the delivery of precision medicine see their programs take hold and influence the next generation of healthcare.Malorye Allison Branca Contributing EditorMalorye Allison Branca Contributing EditorSearch for more papers by this authorPublished Online:29 Dec 2021https://doi.org/10.1089/clinomi.08.06.21AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 6Nov 2021 InformationCopyright © GEN PublishingTo cite this article:Malorye Allison Branca Contributing Editor.TOP PRECISION MEDICINE HEALTH SYSTEMS.Clinical OMICs.Nov 2021.32-36.http://doi.org/10.1089/clinomi.08.06.21Published in Volume: 8 Issue 6: December 29, 2021PDF download

Clinical OMICsVol. 8, No. 3 NewsFree AccessBuilding a Cancer Testing Juggernaut: NeoGenomics leverages key acquisitions to become and to make dominant cancer testing lab in the U.S. and now eyes international marketsChris Anderson, Editor in ChiefChris Anderson, Editor in ChiefSearch for more papers by this authorPublished Online:18 Jun 2021https://doi.org/10.1089/clinomi.08.03.23AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail In 2015, roughly two years after cancer testing laboratory NeoGenomics completed its initial public offering on the Nasdaq that sought to raise roughly $8 million to fund the company's continuing expansion, word came of a merger between NeoG-enomics and Clarient Diagnostics Services, a division of GE. At first blush, one might have thought that GE was making good on its vow to turn its cancer diagnostics company—acquired five years earlier for $587 million—into a $1 billion business by bringing on board the up-and-coming cancer diagnostics player NeoGenomics.But then the kicker. GE was not growing its business by gobbling up a smaller player, it was the other way around. Corporate giant GE was throwing in the towel and small-cap NeoGenomics had swooped in with $350 million in cash and stock to turbo charge its own plans to become the preeminent cancer diagnostics company in the U.S. At the time of the deal, NeoGenomics' market cap of $300 million was lower than Clarient's acquisition price.According to Douglas VanOort, company executive chairman who served as CEO of the company from 2009 until April, the acquisition of Clarient was one of a handful of pivotal moments for the company over the past ten years. “Our growth has occurred in the backdrop of precision oncology becoming more of a powerful force, so we have had a little wind at our back in terms of what has happened in cancer care,” VanOort told Clinical OMICs, who noted that Clarient was four times the size of NeoGenomics when he first started with the company.Douglas VanOort, executive chairman, NeoGenomicsWhile the Clarient deal solidified NeoGenomics as a national player in cancer testing, it wasn't done. Three years later it acquired Carlsbad, CA-based Genoptix, the next largest cancer testing lab competitor, for $125 million.“What we did as a result of those two acquisitions, is we now had enough scale so that we could be a very powerful provider for the community pathologists, hospitals, and oncologists offering a comprehensive cancer testing menu to serve their needs,” VanOort said.The new NeoGenomics headquarters in Fort Myers, FL, is in the final stages of construction and is scheduled to open its doors in September.Today, the company, which recorded a bit more than $66 million in revenue during its first year as public company in 2013, racked up sales of more than $444 million in 2020 and processed roughly one million cancer diagnostics tests.This year also marks the beginning of what is likely the next phase of growth for NeoGenomics as it eyes leveraging its position as the number one cancer testing company in the U.S. to expand worldwide. For this next chapter, VanOort stepped down as company CEO in mid-April, replaced by former Astra Zeneca EVP and CEO of Ironwood Pharmaceuticals, Mark Mallon.Mark Mallon, CEO, NeoGenomicsThe year got off to a quick start as the company announced two key acquisitions aimed at bolstering its core clinical, pharma services, and informatics divisions. In March, it acquired Trapelo Health for $65 million, an oncology decision support platform that will strengthen its informatics offerings; and in early May it announced plans to acquire U.K-based liquid biopsy company Inivata for $390 million. NeoGenomics plans to leverage Inivata's testing capabilities in both its clinical and pharma services divisions.As new CEO Mallon sees it, continuing to build the breadth and depth of the tests and services it offers is what will set the company apart in all three of its business units. “It is not about having one new test or one particular test,” Mallon said. “It is the customer focus and broad portfolio—that is why we are so successful.”With these pieces in place, Mallon said he will call on his deep experience in pharma and international operations as the company looks to play a more significant role in markets overseas.Broad clinical Dx offeringsAt the heart of what NeoGenomics counts as its advantage in cancer testing is its broadening menu of cancer diagnostics using an array of technologies and platforms including fluorescence in suit hybridization (FISH), immunohisto-chemistry (IHC), in situ hybridization, (ISH), flow cytometry, cytogenics, and molecular testing.While traditional testing methods form the backbone of the company's offerings, Mallon sees molecular testing playing an increasing role in the years ahead. “Part of our opportunity is the newer diagnostics, with next-gen sequencing and liquid biopsy,” he said.The plan to acquire Inivata highlights what is possible with these new technologies. Inivata's core PCR multiplexing technology is its InVision First Lung test for non-small cell lung cancer and its newest launch RaDaR a multi-tumor assay for the detection of residual disease and recurrence based on the InVision liquid biopsy platform.NeoGenomics' core mission is to enable doctors to improve cancer outcomes by providing more precise therapies to their patients.According to VanOort, the addition of Inivata's technology helps fill out its cancer testing menu and gives it a solid position for growth in the liquid biopsy and residual disease and cancer recurrence market—an addressable market the NeoGenomics' management team pegs at $15 billion annually.“The addition of Inivata's leading liquid biopsy technology for detecting circulating tumor DNA will allow NeoG-enomics to provide testing solutions to our physicians and their patients for diagnosis, prognosis, therapy selection and now also for post intervention detection of residual disease and for recurrence monitoring,” VanOort said in company conference call announcing the acquisition.VanOort singled out Inivata's RaDaR test as the big prize in the buyout. “The sensitivity of this test, we believe—and all the KOLs and experts we consulted believe—is probably the best out there,” he said.Inivata has published data detailing the high sensitivity of the test and it seems poised, with NeoGenomics as a marketing engine, for broad adoption.“While the published clinical data and high levels of sensitivity for RaDaR are compelling, perhaps the most exciting aspect about RaDaR and MRD testing in general is the paradigm shifting impact it can have for patients along their cancer journey,” noted Clive Morris, Inivata CEO, in the conference call. “In the adjuvant post-surgery setting, RaDaR can potentially be used to help select patients for adjuvant therapy based on the presence of residual circulating tumor DNA in the blood, indicating that the patient has not been cured by their surgery. In the future, the test may also be able to help optimize the dosing or duration of therapy. RaDaR testing can also be used to monitor for disease recurrence for cancer patients that are in remission.”Clive Morris, CEO, InivataPharma servicesNeoGenomics launched its pharma services division in 2015, with two employees, one of whom was hired from Clarient and then effectively reunited the pharma services team from Clarient when it acquired the company a short time later.Its first foray into providing service to drug developers came via a partnership with Covance a couple of years prior, in 2013, as the CRO was looking for a diagnostics partner for its work in oncology. VanOort said the partnership provided NeoGenomics with what amounted to a “Good Housekeeping seal of approval” from its affiliation with Covance. But the partnership was short-lived, as the CRO was acquired the next year by clinical lab giant LabCorp.Another CRO relationship was announced in February this year with Parexel, which allows the CRO to tap into Neo's rich genomic dataset and real-world data to help drive development of precision therapies and for patient stratification for clinical trials.According to Angela Qu, vice president of translational medicine and clinical develop at Parexel, accessing NeoG-enomics' data will allow the company to provide guidance and proof-of-concept for clinical trials. “NeoGenomics is a lab provider for oncology testing,” Qu noted, “but they have a very rich database around oncology patient data to help optimize trial design and expedite (clinical) trials.”While NeoGenomics has established a number of CRO partnerships, VanOort is clear that its reach into the pharma segment does not rely on them. “We've had a number of partnerships in the CRO space, but the way we work with pharma is to sell direct,” he said. “We have a very tenured and skilled sales team that deals with the researchers and the people who are placing trials. We like that go-to-market strategy.”Mallon also touts the RaDar technology of Inivata as being an engine for future growth in pharma services. He noted that as oncology therapeutics increasingly target ever smaller populations with precision therapies, the sensitivity of RaDar can ensure that clinical trials can target only the appropriate patients based on their molecular profile and could potentially transform how pivotal studies are conducted.“The challenge today is you have to enroll a huge number of patients because many if the people that have had the surgeries, maybe as many as 70% to 80% of them don't have cancer,” Mallon said. “Today, when pharma companies do those studies, those patients are all enrolled in studies and the result is you have to do very large studies, hundreds and hundreds of patients, over a long period of time to show an improvement of your new therapy over the existing standard. With RaDaR, we can effectively eliminate all those patients who are cured and only do the studies on patients who have cancer.”Leveraging dataThe third leg of the stool for NeoGenomics is its informatics division, which seeks to leverage the cancer testing data it has generated via its array of testing options over the last dozen years. According to Bob Bonello, president of the informatics division, he and his team operate with two mandates:“We are revenue generating in and of ourselves, but we are also creating products and solutions that are designed to make our pharma services and clinical service divisions more competitive,” he said.Similar to other company divisions, informatics will grow via organic growth, but also through targeted acquisitions such as the $65 million purchase of oncology clinical decision support company Trapelo Health earlier this year.According to Clynt Taylor, founder and CEO of Trapelo, the decision support platform serves oncologists by identifying which biomarkers a cancer patient should be tested for. It then provides a listing of lab service providers who can test for those biomarkers and via its work with some payers, whether a particular patient's health plan will reimburse for that testing.Trapelo came into NeoGenomics' crosshairs, Bonello said, as the company was actively looking to add a clinical decision support tool to its arsenal and had made a strategic decision that it was not going to build this function from scratch. With Trapelo, NeoGenomics felt it “had some particular knowledge and product expertise that we could bring to the table to help make the solution easier to adopt and a provider to use in their day-to-day interactions,” Bonello added. “Now we are trying to marry it with our knowledge of how oncologists order tests and interact with laboratories.”Bonello sees the Trapelo platform as a foundational tool that can not only help clinicians choose the appropriate diagnostic to order for their oncology patients, but one that can also support other areas of the business. First on the agenda is developing a patient portal that will allow patients to log onto Trapelo to see the results of their oncology testing.But the vision for what the fully developed patient portal will be goes well beyond simply being a repository of tests results, Bonello noted. “We will evolve that so it will become a patient-friendly version of those test results. Over time we will develop additional resource for them to learn what is their particular cancer, or what it is the significance of their test result, what are the therapies that are indicated by these results,” he said. “Ultimately, we would like it to be a place that patients could learn about clinical trial opportunities that are appropriate and connect them with investigators who are recruiting for clinical trials.”Further into the future, NeoGenomics envisions creating a provider portal using de-identified data that can create insights into trends in testing such as which diagnostics were most often ordered for particular cancers, or whether patients typically were receiving testing for all the biomarkers recommended by NCCN guidelines for their form of the disease. Eventually, the company vision is to use the underlying technology platform of Trapelo to reach across patients, providers, payers, and biopharma to be the engine that marries the data to match the best therapy to the patient, at the most appropriate time.And as NeoGenomics eyes the international markets for its services, reaching across these stakeholder groups is what Mallon believes will allow it to be successful.“We should be not only aiming at being the leading diagnostic company for testing and information, we should be the leading oncology testing services company for pharma,” Mallon concluded. “We are having success with both biotechs and big pharma. It is already a very substantial business in the U.S., so in a couple of years I think we want to be known as a leader in the U.S. and outside the U.S.”FiguresReferencesRelatedDetails Volume 8Issue 3May 2021 InformationCopyright © GEN PublishingTo cite this article:Chris Anderson, Editor in Chief.Clinical OMICs.May 2021.28-31.http://doi.org/10.1089/clinomi.08.03.23Published in Volume: 8 Issue 3: June 18, 2021PDF download

Clinical OMICsVol. 8, No. 4 NewsMuch More than Child's Play: Natera, originally focused on Noninvasive Prenatal Testing, has leveraged its cfDNA technology for other diagnostic applications in transplantation and oncologyChris Anderson, Editor in ChiefChris Anderson, Editor in ChiefSearch for more papers by this authorPublished Online:26 Aug 2021https://doi.org/10.1089/clinomi.08.04.25AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 4Jul 2021 InformationCopyright © GEN PublishingTo cite this article:Chris Anderson, Editor in Chief.Much More than Child's Play: Natera, originally focused on Noninvasive Prenatal Testing, has leveraged its cfDNA technology for other diagnostic applications in transplantation and oncology.Clinical OMICs.Jul 2021.40-42.http://doi.org/10.1089/clinomi.08.04.25Published in Volume: 8 Issue 4: August 26, 2021PDF download

Clinical OMICsVol. 8, No. 3 NewsFree AccessHyper-Personalized Treatments Get Rulebook From FDA: The first FDA guidance on ASO drug treatments provides a significant step forward, according to experts.Julianna LeMieux, Contributing EditorJulianna LeMieux, Contributing EditorSearch for more papers by this authorPublished Online:18 Jun 2021https://doi.org/10.1089/clinomi.08.03.25AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail A new field of precision medicine, pioneered by a study to design a treatment for one young girl with Batten's disease, is growing—one patient at a time. More and more patients with rare genetic disorders are looking to the future of hyper-personalized treatments for hope. These treatments, consisting of custom antisense oligonucleotides (ASO), are vastly different from traditional medicines designed with the goal of benefiting large groups of patients. The biggest difference? The number of people who could benefit from a hyper-personalized treatment is exceptionally low—as low as one. As such, they demand a newly designed process for regulation.Drafting new guidance on a brand-new class of drug in a field that is in its infancy is not a small task. “I think,” notes Art Krieg, M.D., founder and CEO of Checkmate Pharmaceuticals and past president of the Oligonucleotide Therapeutics Society (OTS), “that the FDA feels pressure from patient groups to simplify the normal drug development process in the case of these unique or nearly unique mutations. But they also have to be thoughtful that the precedents set in these cases do not have unintended consequences.”Recently, FDA published a draft guidance for regulating these drugs entitled, “Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases.” The response from those in the field has been positive.“I'm thrilled,” says Stanley Crooke, M.D., co-founder of n-Lorem, a non-profit dedicated to providing experimental ASO treatments to help desperate patients with ultra-rare mutations. “It's a very significant step forward.”There are three big reasons, Crooke explains, for his positivity. The first is timing. What this field is doing, he explains, “stresses every element of the legislation, policy, regulation that you can imagine.” As a result, the pace of producing a relatively definitive and specific set of guidelines, as rapidly as they have, is “truly remarkable.”Krieg agrees with Crooke. He told Clinical OMICs that the FDA has been “quite proactive” in considering this work since the first case was performed in 2019. That year, Tim Yu, M.D., associate professor in pediatrics at Boston Children's Hospital, led the team that designed and administered a drug named Milasen to a young girl with Batten's disease named Mila Makovec. The drug, and the case (which garnered international attention), were landmarks for the field despite their failure to provide a cure—Mila died earlier this year.Crooke, the founder and executive chairman of Ionis Pharmaceuticals, where he served as CEO for more than 30 years, cites two other reasons why he is pleased with the guidance: 1) it is focused on ASOs and 2) it reflects a good understanding of the technology. It also provides guidance to less mature technologies regarding what they need to have in place should they want to try to help these patients.Lastly, Crooke is pleased because n-Lorem had submitted extensive proposals and they “essentially got everything we asked for.” He adds that there were a couple of extra items that they didn't ask for that will help—especially in patients who are progressing rapidly toward death or a permanent disability.In response to the development of antisense oligonucleotides therapies for the treatment of hyper-personalized treatments, the FDA published a draft guidance for regulating these drugs entitled, “Non-clinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases.”U.S. Food and Drug Administration / WikiMedia CommonsNo wasted timeHaving FDA guidance in place will speed up the process of drug development, which is a top priority. With the new guidance, patients can begin treatment sooner—potentially even three months sooner—than they could before. One aspect that hastens the process is streamlining of the toxicology studies. The new guidance allows patients to receive drugs before the toxicology studies have been completed. In addition, the studies can be performed in a single animal species. This change, Crooke thinks, will enable them to help patients that they might otherwise lose.Many of the other details outlined in the guidance are consistent with n-Lorem's current process. But Crooke says that the importance lies in knowing the rules. Before the guidance, he says, investigators were “operating in a vacuum of rules.”Long road ahead“The guidance is a great first step,” notes Krieg, who has spent decades working in the oligonucleotide field. But he says it does not address all of the issues. As more is learned, Krieg notes, it is possible the guidance may evolve to reflect new learnings.One thing that Crooke would like to see—and has submitted a substantial proposal to address—are specifics on how to guarantee that quality systems are in place. How will the field ensure that they have good treatment plans for each patient and that the patients are treated with the best ASO possible? That is not a trivial undertaking, he asserts. For Crooke, this is of the utmost importance because, “we cannot add any unnecessary risks to these patients.”Krieg adds that there are many different platforms, designs, and chemistries for developing RNA therapeutics. “It's not easy to develop a policy that can be generally applicable,” he says. The questions he thinks that will need to be addressed in the future include: what measure of efficacy is used to define success? How can treatment be monitored? And can a customized oligo be approved so that insurance companies will reimburse for the treatment?The key question now for Krieg is how the FDA and the investigators and academic centers developing these new therapies will implement this guidance in the most responsible way possible. “We all want to move quickly,” he notes, “but we also don't want to create unrealistic expectations on the part of patients or their families that an individualized oligo is going to be a miracle drug for their condition.” Beyond the work of the OTS and others to advance this work, he adds, “society as a whole needs to address the questions of how to ensure equitable access to these drugs for patients with amenable mutations, while working to continue to reduce the cost of development and streamlining the process further.”Ultimately, says Crooke, FDA guidance allows investigators to know that they are on the right path from day one, which is an important step for the patients and their families. A common feature of drug development, he explains, is that you think you're doing what is required but then you find out that you have to go back and do something else. As Crooke says, “we simply can't afford that with these patients.”FiguresReferencesRelatedDetails Volume 8Issue 3May 2021 InformationCopyright © GEN PublishingTo cite this article:Julianna LeMieux, Contributing Editor.Clinical OMICs.May 2021.38-39.http://doi.org/10.1089/clinomi.08.03.25Published in Volume: 8 Issue 3: June 18, 2021PDF download

Clinical OMICsVol. 8, No. 4 NewsFrom Hype to Utility: Artificial intelligence is emerging from its overhyped past to provide analytical muscle in precision medicineHelen AlbertSenior EditorHelen AlbertSenior EditorSearch for more papers by this authorPublished Online:26 Aug 2021https://doi.org/10.1089/clinomi.08.04.21AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 4Jul 2021 InformationCopyright © GEN PublishingTo cite this article:Helen AlbertSenior Editor.From Hype to Utility: Artificial intelligence is emerging from its overhyped past to provide analytical muscle in precision medicine.Clinical OMICs.Jul 2021.22-26.http://doi.org/10.1089/clinomi.08.04.21Published in Volume: 8 Issue 4: August 26, 2021PDF download

Clinical OMICsVol. 8, No. 4 Long Reads Can Make Short Work of Rare Disease Diagnostics: Recent success stories bring hope that long read sequencing may make diagnosing rare genetic disease more successfulJulianna LeMieuxContributing EditorJulianna LeMieuxContributing EditorSearch for more papers by this authorPublished Online:26 Aug 2021https://doi.org/10.1089/clinomi.08.04.19AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 4Jul 2021 InformationCopyright © GEN PublishingTo cite this article:Julianna LeMieuxContributing Editor.Long Reads Can Make Short Work of Rare Disease Diagnostics: Recent success stories bring hope that long read sequencing may make diagnosing rare genetic disease more successful.Clinical OMICs.Jul 2021.16-17, 20, 21.http://doi.org/10.1089/clinomi.08.04.19Published in Volume: 8 Issue 4: August 26, 2021PDF download

Clinical OMICsVol. 8, No. 2 NewsThe Race for a Smart Phone-Based COVID-19 Test Heats UpLeveraging a tool most people carry with them, researchers and diagnostics companies hope to create quick, and easy, COVID-19 testingMalorye Allison BrancaMalorye Allison BrancaSearch for more papers by this authorPublished Online:9 Apr 2021https://doi.org/10.1089/clinomi.08.02.17AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookXLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 2Mar 2021 InformationCopyright © GEN PublishingTo cite this article:Malorye Allison Branca.The Race for a Smart Phone-Based COVID-19 Test Heats Up.Clinical OMICs.Mar 2021.12-13.http://doi.org/10.1089/clinomi.08.02.17Published in Volume: 8 Issue 2: April 9, 2021PDF download

Clinical OMICsVol. 8, No. 6 News2021 Year in ReviewCOVID vaccines, digital pathology, whole-genome sequencing of critically ill infants, and comprehensive genomic profiling in cancer all made waves.Chris Anderson, Editor in ChiefChris Anderson, Editor in ChiefSearch for more papers by this authorPublished Online:29 Dec 2021https://doi.org/10.1089/clinomi.08.06.20AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 6Nov 2021 InformationCopyright © GEN PublishingTo cite this article:Chris Anderson, Editor in Chief.2021 Year in Review.Clinical OMICs.Nov 2021.26-30.http://doi.org/10.1089/clinomi.08.06.20Published in Volume: 8 Issue 6: December 29, 2021PDF download

Clinical OMICsVol. 8, No. 4 NewsPowering Diagnostics for Infectious Disease: The COVID-19 pandemic saw a rush of companies developing diagnostics for the infectious disease that should benefit the detection of other diseasesMalorye Allison BrancaContributing EditorMalorye Allison BrancaContributing EditorSearch for more papers by this authorPublished Online:26 Aug 2021https://doi.org/10.1089/clinomi.08.04.24AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 4Jul 2021 InformationCopyright © GEN PublishingTo cite this article:Malorye Allison BrancaContributing Editor.Powering Diagnostics for Infectious Disease: The COVID-19 pandemic saw a rush of companies developing diagnostics for the infectious disease that should benefit the detection of other diseases.Clinical OMICs.Jul 2021.36-39.http://doi.org/10.1089/clinomi.08.04.24Published in Volume: 8 Issue 4: August 26, 2021PDF download

Clinical OMICsVol. 8, No. 6 NewsCatching Cancer Red-HandedScientists and clinicians are using blood samples to detect and track these diseases more accurately than everMike May Contributing EditorMike May Contributing EditorSearch for more papers by this authorPublished Online:29 Dec 2021https://doi.org/10.1089/clinomi.08.06.17AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 6Nov 2021 InformationCopyright © GEN PublishingTo cite this article:Mike May Contributing Editor.Catching Cancer Red-Handed.Clinical OMICs.Nov 2021.20-24.http://doi.org/10.1089/clinomi.08.06.17Published in Volume: 8 Issue 6: December 29, 2021PDF download

Clinical OMICsVol. 8, No. S2 Illuminating Hope for Rare DiseaseCO-PRODUCTION OF CARE FOR RARE DISEASESJason ColquittJason ColquittJason Colquitt, is the founder and chief executive officer of Across Healthcare. He has worked for 22 years building innovative healthcare technologies and is also a rare disease patient who experienced a 32-year diagnostic journey. Through his leadership and vision, Across Healthcare has built a software platform called “Matrix” that supports many rare disease communities successfully using this concept of co-production of care.Search for more papers by this authorPublished Online:29 Dec 2021https://doi.org/10.1089/clinomi.08.S2.08AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"CO-PRODUCTION OF CARE FOR RARE DISEASES." Clinical OMICs, 8(S2), pp. 28–29FiguresReferencesRelatedDetails Volume 8Issue S2Nov 2021 InformationCopyright © GEN PublishingTo cite this article:Jason Colquitt.CO-PRODUCTION OF CARE FOR RARE DISEASES.Clinical OMICs.Nov 2021.28-29.http://doi.org/10.1089/clinomi.08.S2.08Published in Volume: 8 Issue S2: December 29, 2021PDF download

Clinical OMICsVol. 8, No. 5 NewsNavigating Precision MedicineBig data and analytics company Sema4 signals growth trajectory by going public through $500M SPACAlex Philippidis Senior News EditorAlex Philippidis Senior News EditorSearch for more papers by this authorPublished Online:13 Oct 2021https://doi.org/10.1089/clinomi.08.05.20AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 5Sep 2021 InformationCopyright © GEN PublishingTo cite this article:Alex Philippidis Senior News Editor.Navigating Precision Medicine.Clinical OMICs.Sep 2021.28-31.http://doi.org/10.1089/clinomi.08.05.20Published in Volume: 8 Issue 5: October 13, 2021PDF download

Clinical OMICsVol. 8, No. 3 NewsSussing Out COVID-19 Severity: Can genetic variability explain why some people become seriously ill with COVID-19 while others have only mild illness?Helen Albert, Senior EditorHelen Albert, Senior EditorSearch for more papers by this authorPublished Online:18 Jun 2021https://doi.org/10.1089/clinomi.08.03.21AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookXLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 3May 2021 InformationCopyright © GEN PublishingTo cite this article:Helen Albert, Senior Editor.Sussing Out COVID-19 Severity: Can genetic variability explain why some people become seriously ill with COVID-19 while others have only mild illness?.Clinical OMICs.May 2021.22-26.http://doi.org/10.1089/clinomi.08.03.21Published in Volume: 8 Issue 3: June 18, 2021PDF download

Clinical OMICsVol. 8, No. 5 NewsPrecision Through DiversityPopulation diversity in genomics databases is the key to true precision medicineHelen Albert Senior EditorHelen Albert Senior EditorSearch for more papers by this authorPublished Online:13 Oct 2021https://doi.org/10.1089/clinomi.08.05.17AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 5Sep 2021 InformationCopyright © GEN PublishingTo cite this article:Helen Albert Senior Editor.Precision Through Diversity.Clinical OMICs.Sep 2021.12-16, 18, 19.http://doi.org/10.1089/clinomi.08.05.17Published in Volume: 8 Issue 5: October 13, 2021PDF download

Clinical OMICsVol. 8, No. 3 From the EditorFree AccessPicked Up Pieces from an Editor's DeskChris Anderson, Editor in ChiefChris Anderson, Editor in ChiefSearch for more papers by this authorPublished Online:18 Jun 2021https://doi.org/10.1089/clinomi.08.03.01AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail Chris AndersonEditor in ChiefAs an editor, I often have too many things running through my head. Little bits and bats of ideas and thoughts. What follows is my mental housecleaning. In this issue, Contributing Editor Malorye Branca takes a look at Orchid (page 10) and its promise to use polygenic risk scores (PRS) to examine what the risks are that the genetics of two potential parents will result in a child with a higher risk of developing common diseases such as heart disease, stroke, schizophrenia, and even several types of cancer over the course of their (still to be conceived) future life.While the company has begun marketing its service, there is still no indication of any work they are doing to get their test approved for sale—promised later this year. Worse, in the eyes of many, was the company's contention that it could use PRS to help in embryo selection for in vitro fertilization. Not surprisingly, this set off alarms among the research community, ethicists, and diagnostic developers, among others. The reaction was similar to the uproar caused a couple of years ago by Genomic Prediction, another PRS company that promised similar embryo selection techniques geared toward specific traits.More to the point, PRS is an emerging field and its ability to predict risk is still very much in doubt. But what has me most confused, however, are some of the people backing the company—both with their money and advice—including noted population geneticist Carlos Bustamante, and Ann Wojcicki, CEO of 23andMe. What do they see that I, and a host of others, don't?Jonathan Rothberg is at is again. A month or two ago, one of the early pioneers in DNA sequencing brought his eight-year-old company Quantum-Si out of the shadows with the announcement it would go public via the hot funding mechanism of 2021, a special purpose acquisitions company (SPAC), that would value the company north of $400 million.Not surprisingly, Rothberg is looking to leverage semiconductor technology to create what the company dubs a “next-generation protein sequencing platform” with the intent of revolutionizing proteomics. But can he make his latest project work? Given his past disruptive innovations, I'd not bet against him, or Quantum-Si.Finally, last issue we highlighted the efforts of researchers and the non-profit n-Lorem Foundation to create and fund hyper-personalized therapies created with custom antisense oligonucleotides (ASOs). ASOs have shown early promise to create new drugs for the treatment of as few as one patient. Because this falls so far outside the normal drug development paradigm, continued development of ASO therapies have the potential to stress the existing regulatory framework both here in the U.S. and around the world. The FDA, to its credit, has taken notice. It's draft guidance for ASO drug development promises to advance development of these very precise therapeutics.FiguresReferencesRelatedDetails Volume 8Issue 3May 2021 InformationCopyright © GEN PublishingTo cite this article:Chris Anderson, Editor in Chief.Clinical OMICs.May 2021.2-2.http://doi.org/10.1089/clinomi.08.03.01Published in Volume: 8 Issue 3: June 18, 2021PDF download

Clinical OMICsVol. 8, No. 5 NewsA New Player in Companion DiagnosticsBroad-based, NGS cancer tests are making progress as companion diagnostics, but the jury is out whether they can supplant traditional CDx testing methodsChris Anderson Editor in ChiefChris Anderson Editor in ChiefSearch for more papers by this authorPublished Online:13 Oct 2021https://doi.org/10.1089/clinomi.08.05.21AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 8Issue 5Sep 2021 InformationCopyright © GEN PublishingTo cite this article:Chris Anderson Editor in Chief.A New Player in Companion Diagnostics.Clinical OMICs.Sep 2021.32-34.http://doi.org/10.1089/clinomi.08.05.21Published in Volume: 8 Issue 5: October 13, 2021PDF download