ProLung, Inc. presents highest combined sensitivity and specificity values for a truly non-invasive lung cancer solution pursuing FDA clearance at ISRD & ATS joint medical conference
Salt Lake City, UT, October 31, 2019 – ProLung, Inc. (“ProLung” or the “Company”) and its long-time partner ProLung China (a Delaware, USA-based company), both whom are focused on reducing the time to diagnosis for lung cancer patients, presented the most recent ProLung Test™ clinical trial results at the International Symposium on Respiratory Diseases (ISRD) & American Thoracic Society (ATS) Joint Medical Conference in Shanghai, China on October 24, 2019.
The results of the Company’s recently completed large clinical validation trial on its ProLung Test™ returned results of 84% sensitivity, 74% specificity, 79% Positive Predictive Value (PPV) and 81% Negative Predictive Value (NPV). The trial utilized key modifications to the ProLung System protocol and was led by Professor Chunxue Bai from Fudan University, who is also the President of the ISRD & ATS Joint Conference. The study enrolled 486 subjects with 418 effective under the supervision of a Clinical Research Organization (CRO). Dr. Rex Yung, ProLung Chief Medical Officer and Dr. Ning Zhou, PhD, MBA, ProLung China President, were co-presenters at the ISRD & ATS Joint Conference.
Mr. Jared Bauer, ProLung CEO, stated, “These trial results are the highest combined sensitivity and specificity values for a truly non-invasive solution that is pursuing FDA clearance for a lung cancer diagnostic that we’re aware of and this conference was our first opportunity to present our results to the global lung cancer medical community. Our cross-functional team is actively pursuing subset analysis to identify additional learnings that will inform a small follow validation study in the USA to underpin our future FDA de novo submission. We firmly believe that we are on the cusp of dramatically shrinking the slow status quo that can take up to 3.5 years to diagnose an indeterminate pulmonary nodule while also avoiding unnecessary, invasive and expensive procedures on patients with benign nodules.”
About Lung Cancer
Lung cancer is the leading cause of cancer deaths worldwide, killing more than colorectal, breast and prostate cancers combined. There is a severe unmet clinical need to reduce the time required to determine malignancy in patients diagnosed with Indeterminate Pulmonary Nodules (IPNs). Patients with IPNs can wait months, or even years, receiving multiple CT scans to confirm malignancy in the lungs. This wait often proves fatal as the cancer advances and spreads. In 2015, the Centers for Medicare and Medicaid Services (CMS) implemented the first national lung cancer screen utilizing a low-dose CT scan (LDCT) of the chest for high-risk adults, which was based in part on a 2013 recommendation by the US Preventive Services Task Force (USPSTF). The screen will amplify this clinical need as up to 24 million patients with IPNs may experience a narrowing treatment window as they wait.
About ProLung, Inc.
ProLung is a leader in innovative predictive analytics technology and non-invasive tests for the risk stratification of indeterminate pulmonary nodules in the lung. ProLung’s mission is to ‘make a difference in time’ for lung cancer patients. The Company is engaged in developing, testing and commercializing solutions which are designed to accelerate the time to diagnosis and expand the therapeutic window for lung cancer patients. ProLung’s predictive analytics platform for lung cancer risk stratification is approved for sale in the European Economic Area (CE0120) and investigational use in the USA.
Statements contained in this release which are not purely historical, including, without limitation statements regarding ProLung’s future performance and goals, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in the ProLung’s Annual Report on Form 10-K for the year ended December 31, 2018 and subsequent filings with the Securities and Exchange Commission. Such risks and uncertainties include inherent risks and uncertainties relating to ProLung’s ability to meet its funding requirements for its operations and other commitments and to obtain successful test results and regulatory approvals for its products. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections.
For further information, contact:
Andy Robertson | 1-801-503-9231| firstname.lastname@example.org
ProLung, Vice President of Business Development
350 W. 800 N., Suite 214
Salt Lake City, Utah 84103