ProLung, Inc. which is focused on reducing the time to diagnosis for lung cancer patients with its ProLung Test™, announced the preliminary results of its PL-208 Validation Study and outlined its next-steps.
Before breaking the Study data blind and analyzing the amassed clinical data, the ProLung team collaborated with the FDA through two formal Pre-Submission Meetings regarding the Company’s PL-208 Study Statistical Analysis Plan, Study design, device output and statistical approaches. Shortly after the last meeting in January 2019, ProLung and its statistical and regulatory consultants determined the Company had received sufficient feedback from the FDA to justify breaking the Study data blind in order to obtain Study results.
In the Validation Set (n=174 subjects), the ProLung Test demonstrated a sensitivity of 68%, specificity of 49%, Positive Predictive Value (PPV) of 70%, Negative Predictive Value (NPV) of 47% and an Accuracy of 61%. These results are preliminary and will be finalized once the Study’s Statistical Analysis Plan report is completed.
Jared Bauer, interim ProLung Chief Executive Officer, stated, ”The PL-208 clinical results are another solid indicator the ProLung Test is capable of identifying a signal that can be used to indicate the risk of malignancy in pulmonary nodules by non-invasively measuring their bioconductance biomarker. With the conclusion of this Study, the ProLung Team is eager to turn its focus on validating a number of already identified hardware, software and data collection improvements designed to strengthen our algorithm’s performance and support a future submission to the FDA. The Company is also in the midst of evaluating a number of potential strategic partnerships to accelerate our development by expanding our financial and support network. It is clear that we have a great deal of sincere support from new and former partners that are converging on the Company to help us succeed.”
PL-208 Study Design and Objectives
The PL-208 Validation Study titled ”A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients with Pulmonary Lesions Suspicious for Lung Cancer,” enrolled 420 patients across the United States at 15 premier cancer centers. The Study is a two-phase study including a 200 subject Stabilization Phase to optimize the Company’s algorithm and a 174 subject Validation Phase to assess the efficacy of the locked algorithm.
The ProLung Test lung cancer prediction algorithm, which includes bioconductance measurements combined with the subject’s age, was compared to the subjects’ actual diagnosis (malignant or benign, based on tissue biopsy or a follow-up CT scan showing radiological stability).
- Sensitivity: proportion of patients with cancer that are correctly identified as such
- Specificity: proportion of patients without cancer that are correctly identified as such
- Positive Predictive Value (PPV): probability that subjects with a positive ProLung Test result truly have cancer
- Negative Predictive Value (NPV): probability that subjects with a negative ProLung Test result truly do not have cancer
- Accuracy: proportion of patients correctly identified
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 indicate risk of 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 and the ProLung Test
ProLung is the world 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 develops, tests and commercializes 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.
The ProLung Test is designed to produce a personalized risk score indicating the likelihood of malignancy in the lungs for patients with IPNs by measuring volume-averaged thoracic bioconductance. Patients at high-risk may be accelerated to biopsy and diagnosis thereby expanding the critical therapeutic window. At the other end of the risk spectrum, patients at low-risk may avoid futile biopsies and justify fewer follow-up CT scans.