BACKGROUND:The diagnosis of lung nodules continues to be a challenge. Confirmed diagnosis allows appropriate treatment for cancers and allows avoidance of more invasive procedures for proven noncancers. Currently, available lung biopsy technologies each have their own limitations, which affect the ability to successfully navigate to a suspicious nodule and to collect a diagnostic sample. Additional advancements in endobronchial navigation, localization, and guided biopsy are needed to obtain higher rates of definitive diagnosis for lung nodules.METHODS:This is a prospective, multicenter study that assessed the localization success rate and diagnostic yield of bronchoscopies guided only by the LungVision platform. Physicians navigated to pulmonary nodules according to a proposed pathway and verified nodule location using radial endobronchial ultrasound before the biopsy.RESULTS:Fifty-five patients were enrolled in the study. Two patients had >1 nodule that was evaluated on the day of the procedure. During bronchoscopy, the nodule localization success rate was 93%. The overall diagnostic yield measured the day of the procedure, based on the immediate rapid on-site pathology report, was 75.4%.CONCLUSION:LungVision provides reliable navigation and ability to biopsy pulmonary nodules with an acceptable success rate. The platform demonstrates a high localization rate of pulmonary nodules.

SESSION TITLE: Monday Fellow Case Report Posters SESSION TYPE: Fellow Case Report Posters PRESENTED ON: 10/21/2019 02:30 PM - 03:15 PM INTRODUCTION: Lung cancer is the lead cause of cancer-related deaths worldwide. Smoking is the primary risk factor for lung cancer. About 80% of lung cancer deaths are accounted for smoking. A longer smoking period and a higher number of cigarettes packages smoked a year are associated with a greater risk. CASE PRESENTATION: The case: A 76 years old female patient was referred to a CT scan due to a history of nodules with previous negative CT-guided needle biopsy. The CT scan has identified 2 suspicious nodules in her lungs. A 12mm nodule in the left lower lobe (LLL) and a 10mm nodule in the left upper lobe (LUL). The patient had no cancer history. The patient is a current smoker of 20 packages a year. The patient was referred to bronchoscopy to biopsy the two suspicious nodules in order to determine patient management care. Methods: The patient was scheduled for navigational bronchoscopy guided by the AI-driven navigation system. (LungVision, Body Vision Ltd, Israel). The patient’s CT scans were imported into the LungVision planning software and Artificial Intelligence assisted to identify the suspicious nodules and the pathway leading to each of the two nodules. The procedure was performed under moderate sedation. The AI-driven navigation system was used for real-time localization of the airways and nodules using fluoroscope images. When the navigation catheter guided by AI has reached the suspicious nodule, a radial EBUS (r-EBUS) probe was advanced down the catheter to verify nodule location prior to taking a biopsy. During the biopsy stage, the tools were guided by LungVision into the lesion visualized over the fluoroscopic screen. ROSE confirmation utilized after the biopsy was performed. Each of the eight biopsy samples assisted by AI-guidance was performed with forceps and a brush from the LLL nodule. Using the same approach two additional biopsy samples were acquired from the LUL using a brush. All samples were marked and sent to the pathology. Results: The total time of the procedure was 58 minutes. Although ROSE was non-diagnostic in both nodules, the LLL nodule was adenocarcinoma at the final path and LUL nodule showed only reactive bronchoalveolar cells. No peri-procedural adverse event was reported. DISCUSSION: Detection of lung nodules at an early stage allows for potentially curative treatment for patients. The ability of AI-driven LungVision system to guide tools into small pulmonary nodules allows a safe non-invasive diagnostic procedure, opening a new avenue in the management of solitary pulmonary nodules. CONCLUSIONS: The AI capabilities to track pulmonary nodules in real time under moderate sedation and present live augmented images of the nodule and airways to enable real-time guided endobronchial navigation and biopsy of pulmonary nodule may increase the diagnostic yield of bronchoscopy. Reference #1: Lung cancer: diagnosis, treatment principles, and screening. Latimer KM et al. Am Fam Physician. (2015) DISCLOSURES: No relevant relationships by Patrick Whitten, source=Web Response

SESSION TITLE: Advances in the Diagnosis of Lung Cancer SESSION TYPE: Original Investigations PRESENTED ON: 10/09/2018 02:30 PM - 03:30 PM PURPOSE: Bronchoscopy is frequently used for evaluation of pulmonary lesions, but its sensitivity for detecting lung cancer can be limited. A bronchial genomic classifier (Percepta) has been validated as a complement to lung cancer diagnostic bronchoscopy to improve its sensitivity and negative predictive value. When bronchoscopy is inconclusive, Percepta can identify patients who can be considered for CT surveillance instead of undergoing another invasive diagnostic procedure. We report here on the clinical utility of Percepta among patients enrolled in the Percepta Registry at up to 12 months post bronchoscopy. METHODS: Patients were prospectively enrolled at 40 medical centers when Percepta was ordered due to an inconclusive bronchoscopy. The classifier sample was obtained by brushing the right mainstem bronchus during bronchoscopy, regardless of nodule size or location. Pre- and post-classifier clinical management recommendations were recorded and follow-up clinical, procedure, and imaging data were collected. RESULTS: 399 patients had an inconclusive bronchoscopy and were within indication (no prior cancer and current or former smoker). The majority of lesions were <30mm (77%), peripherally located (72%), solid (73%), and upper lobe (55%). Advanced bronchoscopic technologies were used in 68% of cases and PET was used prior to bronchoscopy in 37% of patients. This interim analysis focuses on the 289 patients (72%) with intermediate (245) or low (44) pre-test risk of malignancy. 32% of intermediate pre-test risk patients were down classified by Percepta to low risk, and 52% of low pre-test risk patients were down classified by Percepta to very low risk. These results are consistent with the results from the AEGIS 1 and 2 studies (Silvestri et al, NEJM 2015): 38% and 54% down classification, p = 0.85 and p =0.30 respectively. Among patients where risk of malignancy was down-classified by Percepta, physicians significantly reduced invasive procedure recommendations from 41% to 18% in the intermediate pre-test risk and 9% to 0% in the low pre-test risk group. This results in an overall procedure reduction of 34% to 14% (relative reduction of 59%, p=0.0005). 83% of those who were down-classified remained procedure free at 12 months follow up. CONCLUSIONS: We observed a significant reduction in additional invasive procedures compared to the pre-test management plan for patients who were down classified by Percepta after an inconclusive bronchoscopy. This reduction in procedures has been durable over 12 months. Additional data will help further determine the ultimate clinical utility of the test. CLINICAL IMPLICATIONS: A bronchial genomic classifier can reduce the number of unnecessary invasive procedures that are performed following an inconclusive bronchoscopy for suspect lung cancer. DISCLOSURES: No relevant relationships by Sadia Benzaquen, source=Web Response No relevant relationships by Michael Bernstein, source=Web Response Consultant relationship with Medtronic ILS Please note: $5001 - $20000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Biodesix Please note: $5001 - $20000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant relationship with Boston Scientific Please note: $1001 - $5000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant relationship with Merit Endotek Please note: $1001 - $5000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant relationship with BodyVision Please note: $1001 - $5000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant Consultant relationship with Auris Surgical Robotics Please note: $1001 - $5000 Added 03/03/2018 by Krish Bhadra, source=Web Response, value=Consulting fee No relevant relationships by Travis Dotson, source=Web Response No relevant relationships by Mark Esterle, source=Web Response researcher relationship with veracyte Please note: $1-$1000 Added 03/03/2018 by Joshiah Gordon, source=Web Response, value=Grant/Research Support Employee relationship with Veracyte, Inc. Please note: $20001 - $100000 Added 03/05/2018 by Bailey Griscom, source=Web Response, value=Salary Speaker/Speaker's Bureau relationship with Boston Scientific Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Shire Please note: $5001 - $20000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Honoraria Consultant relationship with Auris Please note: $1001 - $5000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Ownership interest Unrestricted Education Grant relationship with Boston Scientific Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Unrestricted Education Grant Consultant relationship with BronchiSense Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with LX Medical Please note: $5001 - $20000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Biodesix Please note: $5001 - $20000 Added 03/02/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Body Vision Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Medtronic Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: >$100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Preora Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Speaker/Speaker's Bureau relationship with Grifols Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Honoraria Consultant relationship with Heritage Biologics Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Boston Scientific Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Gala Therapeutics Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Matrix Analytics Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with OncoCyte Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Owner/Founder relationship with Medical Opinion Systems Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Neurotronic Please note: $1001 - $5000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Veracyte Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Honoraria Employee relationship with Veracyte Inc Please note: >$100000 Added 03/04/2018 by Jing Huang, source=Web Response, value=Salary Employee relationship with Veracyte Please note: >$100000 Added 03/09/2018 by Marla Johnson, source=Web Response, value=Salary Removed 03/09/2018 by Marla Johnson, source=Web Response Employee relationship with Veracyte Please note: $20001 - $100000 Added 03/09/2018 by Marla Johnson, source=Web Response, value=Salary Employee relationship with Veracyte Please note: >$100000 Added 03/27/2018 by Giulia Kennedy, source=Admin input, value=Salary Consultant relationship with Veracyte Please note: $5001 - $20000 Added 03/09/2018 by Hans Lee, source=Web Response, value=Consulting fee Consultant relationship with Veran Medical Please note: $20001 - $100000 Added 03/09/2018 by Hans Lee, source=Web Response, value=Grant/Research Support Employee relationship with Veracyte Please note: >$100000 Added 03/03/2018 by Lori Lofaro, source=Web Response, value=Salary Advisory Committee Member relationship with Exact Sciences Please note: $1001 - $5000 Added 03/05/2018 by Peter Mazzone, source=Web Response, value=Consulting fee Research support relationship with Veracyte Please note: $5001 - $20000 Added 03/05/2018 by Peter Mazzone, source=Web Response, value=Grant/Research Support Research support relationship with Oncocyte Please note: $5001 - $20000 Added 03/05/2018 by Peter Mazzone, source=Web Response, value=Grant/Research Support Consultant relationship with Veracyte Please note: $20001 - $100000 Added 04/30/2018 by Avrum Spira, source=Admin input, value=Salary Consultant relationship with Janssen Pharmaceuticals Please note: $20001 - $100000 Added 04/30/2018 by Avrum Spira, source=Admin input, value=Consulting fee No relevant relationships by Patrick Whitten, source=Web Response

SESSION TITLE: Advances in the Diagnosis of Lung Cancer SESSION TYPE: Original Investigations PRESENTED ON: 10/09/2018 02:30 PM - 03:30 PM PURPOSE: Lung cancer is the lead cause of cancer-related deaths worldwide. Early diagnosis of peripheral pulmonary nodules (PPNs) is a key factor in improving the overall survival rate. Several diagnostic modalities and variety of biopsy tools are currently being used to access PPNs endobronchially. Still, the reported diagnostic yield of PPNs is below 42%. The first challenge for the bronchoscopist is the need to navigate to the PPN thought the complex bronchial tree beyond the bronchoscopic vision. The second challenge is getting a stable sample from the area of interest under the condition of moving and breathing lungs. Today both navigation and biopsy are blind hence decreasing the probability of definitive diagnosis. LungVision is a novel system (LungVision, Body Vision Medical LTD, Israel), that is integrating existing imaging modalities and biopsy tools utilizing novel machine learning and artificial intelligence approach, to enable live guided endobronchial navigation and biopsy of PPNs that has shown to increase diagnostic yield. METHODS: Patients with PPNs referred for bronchoscopy were offered to participate in the study. CT scans were imported into the LungVision planning software, where the physicians identified the PPN and selected the desired pathway. LungVision system was used for real-time localization of the airways and PPN using fluoroscope images. When the LungVision display showed the PPN had been reached, a radial EBUS (r-EBUS) probe was advanced down the catheter to verify LungVision display and r-EBUS image at the tip of the catheter was captured. Finally, the desired tissue samples were taken under LungVision guidance. RESULTS: 20 patients were enrolled to the study. The average age was 67. Average PPN size was 21.6mm+11.9 (range 5-50mm, Median 18mm), and 69% of the PPNs were located in the upper lobes.No peri-procedural adverse events were reported. PPNs location displayed in real time by the LungVision system was verified successfully by r-EBUS in all cases (100%). Tissue samples were successfully acquired under LungVision guidance with a diagnostic yield of 75%. A follow up is now in progress for indeterminate samples. CONCLUSIONS: Some navigation systems available today to physicians, such as ENB or VB, are relying on virtual pre-procedure imaging. These modalities are not capable of presenting real-time images during navigation nor during sampling of the PPN. LungVision’s ability to integrate routinely any available imaging modality including a bronchoscope, fluoroscope and r-EBUS together with off the shelf biopsy tools during navigation and biopsy, allows physicians to maintain their protocol for diagnosis of PPNs, while adding the revolutionary benefit of augmented real-time imaging to increase diagnostic yield. CLINICAL IMPLICATIONS: A novel system that enables live guided augmented endobronchial fluoroscopic navigation and biopsy of PPNs DISCLOSURES: No relevant relationships by Patrick Whitten, source=Web Response

SESSION TITLE: Advances in Diagnostic Modalities of Peripheral Lung Nodules SESSION TYPE: Original Investigations PRESENTED ON: 10/07/2018 02:15 PM - 03:15 PM PURPOSE: Early detection of lung cancer relies on an accurate identification and diagnosis of peripheral pulmonary nodules (PPNs). Many prior modalities use different approaches to access and biopsy PPNs but with mixed success and different levels of risks. A technology that supports real-time augmented fluoroscopic visualization of an endobronchial navigation pathway during PPN sampling that could deliver excellent diagnostic yield combined with low complication risk was not available until recently. LungVision (LungVision, Body Vision Ltd, Israel) is a novel system utilizing machine learning and artificial intelligence approach to enable live guided augmented endobronchial fluoroscopic navigation and biopsy of PPNs. Cone beam CT (CBCT) allows us to measure the system accuracy and evaluate the impact of breathing movements on the diagnostic yield. LungVision is capable to dynamically track PPNs and compensate for respiratory motion during both navigation and biopsy. This is a summary of a 2 years study describing PPNs localization success and diagnostic yield using LungVision. METHODS: Patients with PPNs referred for bronchoscopy were included in the study. CT scans were imported into the LungVision planning software and the researcher identified the target PPN and selected the desired pathway. LungVision system was used for real-time localization of the airways and PPN and for directional guidance and assistance during biopsy. A flexible bronchoscope was directed to the lobe of interest and a fluoroscopically visible, steerable catheter was introduced through a working channel. The catheter was guided to the electronically highlighted target by following a pathway overlaid on the fluoroscopy image. When the LungVision display showed the PPN had been reached, a radial EBUS probe or a cone Beam CT were used to confirm catheter localization to the PPN. Finally, the desired tissue samples were taken. RESULTS: 200 patients were recruited to the study in 6 centers in the U.S. Average age was 69+10, 36% were male. Average PPN size was 17mm (Median 17), and 70% of the PPNs were located in the upper lobes. No peri-procedural adverse events were reported. Successful localization to the PPN, according to LungVision display, was achieved in 86 % of the cases. The diagnostic yield is 78%. CONCLUSIONS: Augmented endobronchial fluoroscopic navigation is safe, feasible and accurate real-time PPNs localization modality. LungVision’s ability to track in real time the localization of PPNs (as small as 5mm, and a median of 17mm) while compensating for tissue motion and its support of image-guided transbronchial biopsy are contributing to improved diagnostic yield. This initial data highlights how LungVision can contribute to diagnostic navigation bronchoscopy. CLINICAL IMPLICATIONS: Improved methods for peripheral biopsy are needed. This is a new and novel approach to aid the bronchoscopist. DISCLOSURES: Consultant relationship with Medtronic ILS Please note: $5001 - $20000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Biodesix Please note: $5001 - $20000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant relationship with Boston Scientific Please note: $1001 - $5000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant relationship with Merit Endotek Please note: $1001 - $5000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant relationship with BodyVision Please note: $1001 - $5000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant Consultant relationship with Auris Surgical Robotics Please note: $1001 - $5000 Added 03/03/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Boston Scientific Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Shire Please note: $5001 - $20000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Honoraria Consultant relationship with Auris Please note: $1001 - $5000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Ownership interest Unrestricted Education Grant relationship with Boston Scientific Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Unrestricted Education Grant Consultant relationship with BronchiSense Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with LX Medical Please note: $5001 - $20000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Biodesix Please note: $5001 - $20000 Added 03/02/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Body Vision Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Medtronic Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: >$100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Preora Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Speaker/Speaker's Bureau relationship with Grifols Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Honoraria Consultant relationship with Heritage Biologics Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Boston Scientific Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Gala Therapeutics Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Matrix Analytics Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with OncoCyte Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Owner/Founder relationship with Medical Opinion Systems Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Neurotronic Please note: $1001 - $5000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Veracyte Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Honoraria Consultant relationship with Medtronic Please note: $5001 - $20000 Added 03/03/2018 by Michael Pritchett, source=Web Response, value=Consulting fee No relevant relationships by Patrick Whitten, source=Web Response

SESSION TITLE: Top Posters - Electronic session SESSION TYPE: Original Investigation Poster PRESENTED ON: Monday, October 30, 2017 at 12:00 PM - 01:30 PM PURPOSE: Despite improved prediction models for lung nodules, many require tissue diagnosis for further management. Of the alternatives, transbronchial sampling of peripheral lung nodules has the greatest safety profile and is the initial procedure of choice for many institutions. Electromagnetic Navigation Bronchoscopy (ENB) offers advantages over a traditional bronchoscopic approach, but suffers numerous pitfalls: it is costly, time consuming, and despite an increased yield results in a diagnosis in only around 70% of cases. One concern with ENB is its reliance on a virtual target lesion without real-time real-nodule guidance. Here we present a technical feasibility study of a novel fluoroscopic transbronchial guidance technology that provides live actual patient imaging without reliance on virtual navigation. Pre-specified primary endpoint of this study was accurate localization of pulmonary nodules in various regions of the lung, as verified by radial endobronchial ultrasound probe (REBUS). METHODS: 85 patients with peripheral lung nodules at 3 separate institutions were enrolled over a 12-month period. Computed tomography scans were used for target identification and bronchial pathways were determined by the LungVision planning software. General or moderate sedation was utilized based on operator preference. A flexible bronchoscope was driven to the lobe of interest and a fluoroscopically visible steerable catheter was introduced through the working channel (Medtronic EWC). The catheter was guided to the electronically highlighted target by following a pathway electronically overlaid upon the fluoroscopy image. The procedure was considered a technical success when LungVision view matches the radial endobronchial ultrasound probe visualization of the target area. RESULTS: 85 patients underwent fluoroscopic guidance to peripheral lung nodules. Anesthesia type was general in 64 cases and moderate in 21 case. All lung lobes were represented in the study, while the majority of 72% were upper lobe nodules. The average nodule size was 22.8 mm (range 7-46 mm). The average procedure time was 57.98 minutes (range 23-140). No peri-procedural adverse events were reported. The procedure was considered technically successful in 78 of 85 procedures (92%). Of the unsuccessful procedures two were due to hardware setup malfunction, one was due to inadequate patient sedation resulting in procedural termination, and two were due to provider preference to use a different path than the one originally planned, two due to the navigation catheter limitation of reaching the target area of interest. CONCLUSIONS: Augmented endobronchial fluoroscopic navigation is safe, feasible and accurate real time lesion localization modality. Further large-scale studies are indicated to assess the possible role of LungVision as a potential method of choice for the image-guided biopsy of peripheral lung lesions. CLINICAL IMPLICATIONS: Technologies that rely on virtual guidance rely on temporally remote imaging to chart a navigation pathway to peripheral lung nodules, this techonology which utilizes real-time real-nodule guidance represents a technological advancement and provides improved diagnostic accuracy. DISCLOSURE: The following authors have nothing to disclose: Sean Stoy, Douglas Hogarth, Akrum Al-Zubaidi, Patrick Whitten We are presenting a technical feasibility study of a novel transbronchial guidance technology that provides live actual fluoroscopic peripheral pathway guidance of bronchoscopes, extended working channels, and transbronchial biopsy tools without reliance on virtual navigation

SESSION TITLE: Advances in Lung Cancer SESSION TYPE: Original Investigation Slide PRESENTED ON: Wednesday, November 1, 2017 at 08:45 AM - 10:00 AM PURPOSE: The Bronchial Genomic Classifier (BGC) improves the sensitivity and negative predictive value (NPV) of bronchoscopy for lung cancer detection. The BGC identifies patients who, with a pre-test intermediate (10-60%) risk of malignancy, and an inconclusive diagnostic bronchoscopy result, are at low risk of malignancy (<10%) and may be considered for radiographic monitoring instead of an additional invasive procedure. We report a planned interim utility analysis from a prospective, multi-center registry study of the BGC, designed to observe patient selection, classifier performance, clinical utility and safety across varied clinical settings. METHODS: The BGC Registry enrolls patients at 43 medical centers who have had an inconclusive diagnostic bronchoscopy for suspected lung cancer, and for whom the BGC was ordered. The BGC sample is obtained by brushing the normal appearing mucosa of the central airway during bronchoscopy. The BGC is measured in those samples after cytology on biospecimens collected at bronchoscopy are confirmed inconclusive. Pre- and post- BGC clinical management recommendations are recorded and follow-up clinical and imaging data are collected at regular time points up to 36 months. RESULTS: 665 eligible patients underwent a diagnostic bronchoscopy for evaluation of lung cancer. A diagnosis was made in 259 (39%) patients at index bronchoscopy: 182 (27%) with lung cancer and 77 (12%) with a benign condition. The BGC was not ordered in 39 (6%) patients and 13 (2%) were not consented, leaving 354 patients meeting enrollment criteria. Of these, 315 patients are evaluable with exclusions of 17 (2%) patients with a BGC 'no-result', and 22 patients with insufficient data. Demographics showed 60% ≥ 65 y/o; 50% female, with a median 40 pack-year smoking history. This interim analysis focuses on 209 (66%) patients with an intermediate pre-test risk of malignancy where CT scans showed 76% of index lesions were ≤ 30 mm, 69% were peripherally located, 60% were solid and 50% were in the upper lobe. Advanced bronchoscopic technologies were used in 68% of cases. The BGC test results reclassified 74 (35%) pre-test intermediate risk patients to post-test low risk. At 10-months median follow-up, the reclassified low risk group showed a 17% absolute (40% to 23%), or 40% relative reduction in the use of invasive procedures compared to their pre-test diagnostic management plan. Patients who remained intermediate post-test risk showed no increase in invasive procedures. Five (2%) reclassified low risk patients have, at a median of 10-months follow-up, been diagnosed with lung cancer, well within the NPV of the test (91%). Four of five patients have undergone successful resection without evidence of a stage shift. CONCLUSIONS: This interim analysis from this prospective registry confirms the performance of the BGC reported in the AEGIS I and II studies.The emerging safety of reclassified low risk patients is encouraging. Additional follow-up is required to evaluate the full impact of clinical utility. CLINICAL IMPLICATIONS: The BGC improves the sensitivity of diagnostic bronchoscopy for patients undergoing evaluation for lung cancer and can reduce the number of unnecessary invasive procedures that are performed following an inconclusive procedure. DISCLOSURE: Douglas Hogarth: Grant monies (from industry related sources): Industry funded research, Consultant fee, speaker bureau, advisory committee, etc.: Advisor Board Joshiah Gordon: Other: Paid for time it takes to enroll patients Kate Smith: Employee: I receive a salary and hold stock options from Veracyte. Pauline Bianchi: Employee: Employed by Veracyte Marc Lenburg: Consultant fee, speaker bureau, advisory committee, etc.: Veracyte, Grant monies (from sources other than industry): NIH Avrum Spira: Consultant fee, speaker bureau, advisory committee, etc.: Advisor The following authors have nothing to disclose: Hans Lee, Patrick Whitten, Krish Bhadra, Travis Dotson, Sadia Benzaquen, Michael Pritchett, Ajay Bedekar, Mark Esterle No Product/Research Disclosure Information

SESSION TITLE: Procedures 2 SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, October 26, 2016 at 01:30 PM - 02:30 PM PURPOSE: A bronchial genomic classifier was developed and validated to improve the sensitivity and NPV of bronchoscopy for lung cancer detection. The Percepta® classifier identifies patients at low risk of malignancy who may be considered for radiographic monitoring instead of invasive procedure following inconclusive bronchoscopy. This registry is designed to observe physician adoption, evaluate the impact of Percepta on management decisions, and monitor test safety. METHODS: This prospective observational registry was developed in accordance with guidelines published by the Agency for Healthcare Research and Quality. Patients recommended for diagnostic bronchoscopy by their physicians as part of a work-up for suspected lung cancer are eligible for participation. The Percepta sample is obtained by brushing the right mainstem bronchus during the bronchoscopy and held until cytology is confirmed as inconclusive. Registry enrollment occurs upon receipt of the Percepta test order. Demographic and clinical data are collected upon enrollment along with physician assessed pre-bronchoscopy risk of malignancy and imaging data. Pre- and post-Percepta test clinical management recommendations are recorded. Additional follow-up clinical and imaging data are collected at regular time points up to 36 months. All participating sites undergo training on the Percepta test performance, report interpretation and specimen collection techniques. Safety incidents undergo root cause analysis and review by clinical advisors. Statistical analysis will examine the difference in invasive test usage following bronchoscopy between those patients with an intermediate pre-test risk (10-60%) for lung cancer who have a Percepta positive versus negative test result. With as few as 85 evaluable study participants the registry has 80% power to detect a 2-fold or greater reduction in invasive test usage in patients with a negative Percepta test result. RESULTS: Seventy-seven patients have been screened and 49 enrolled across 25 sites (11 academic, 12 community, and 2 VA). Patient demographics include: 42% < 65 y/o (range 30-89 y/o), 48% female, and a median 45 pack-year smoking history. Seventy percent of patients had a physician assessed pre-bronchoscopy intermediate risk of malignancy. Sixty percent of index lesions were ≤ 20 mm (range 6-67mm) and 77% were peripherally located. Navigational bronchoscopy was used in 66% of cases with half of those using radial EBUS. One third of patients had adenopathy reported at enrollment. No safety events have been reported. Pre- and post-test decision impact and 3-6 month utility metrics indicate that the test has impacted down-stream decision making. CONCLUSIONS: Prospective physician adoption of the Percepta classifier involves patients where bronchoscopy alone has been previously shown to have low sensitivity for detecting lung cancer, but who are at substantial risk for lung cancer based on pre-test assessment. CLINICAL IMPLICATIONS: By improving the sensitivity of bronchoscopy and enhancing identification of low-risk lesions, Percepta may make bronchoscopy a more useful tool in the work-up of patients with suspected lung cancer. Appropriate clinical adoption is an important first step in demonstrating clinical utility of this classifier. DISCLOSURE: Douglas Hogarth: Consultant fee, speaker bureau, advisory committee, etc.: consultant with Veracyte The following authors have nothing to disclose: Travis Dotson, Hans Lee, Patrick Whitten, Marc Lenburg No Product/Research Disclosure Information

BACKGROUND: ASPIRE, a multicenter randomized controlled trial to evaluate AeriSeal System endoscopic lung volume reduction (LVR) for advanced upper lobe predominant emphysema, was conducted from 9/2012-11/2013. It was terminated for non-regulatory reasons after 95/300 patients were randomized. AIM/METHODS: ASPIRE compared AeriSeal Lung Sealant therapy plus medical treatment to medical treatment alone with a 3:2 randomization and planned 3, 6, 9, and 12 month follow-up. The primary endpoint was 12 month FEV 1 improvement. Secondary endpoints included changes in St. George's Respiratory Questionnaire (SGRQ), Medical Research Council Dyspnea score (MRCD), and 6-minute walk test (6MWT). Subjects underwent pulmonary rehabilitation. RESULTS: At termination, safety data were available for 90 patients. Efficacy results were available at 3 months for 57 patients (34 treatment group, TG; 23 control group, CG) and at 6 months for 32 patients (19 TG, 13 CG). Improvements at 3 months persisted at 6 months. Δ from baseline 3 mo-TG 3 mo-CG P 6 mo-TG 6 mo-CG P FEV1(%; mL) 16±20; 125±168 1±11; -1±108 0.0003 26±42; 174±317 3±11; 31±145 0.03 SGRQ(U) -9±13 -2±9 0.02 -13±15 -3±6 0.02 MRCD(U) -0.9±1.1 -0.0±0.8 0.002 -0.6±1.2 -0.5±0.7 0.61 6MWT(m) not assessed at 3 mo 16±52 -17±46 0.08 43% of TG and 16% of CG patients experienced AEs requiring hospitalization (P<0.05); the majority were respiratory (39% TG vs. 15% CG). There were 2 deaths in the TG (1 treatment-related); none in the CG. CONCLUSION: Interim results confirm prior open label studies showing hydrogel-based LVR improves physiology and patient reported outcomes compared to optimal medical therapy in patients with advanced emphysema, but with increased AE risk requiring hospitalization.