NEW YORK – Freenome said Tuesday that it is initiating a new study called PROACT LUNG, which aims to validate the clinical performance of its lung cancer screening blood test. If successful, the trial will support an application for US Food and Drug Administration approval of the test.
The test, Freenome's second assay developed using its multiomics platform, combines lung cancer-specific and other cancer-associated markers. The firm's first test, also being clinically validated, targets colorectal cancer.
According to the company, only 6 percent of eligible individuals are currently screened for lung cancer, with fewer than 25 percent of them adhering to recommended annual CT imaging.
PROACT LUNG is a prospective observational study recruiting current and former smokers 50 years and older who are eligible for screening with low-dose CT, consistent with recently updated screening guidelines. Investigators plan to evaluate the sensitivity, specificity, and positive and negative predictive values of the test in detecting lung cancer within 12- and 24-month follow-up periods.
Freenome said it aims to enroll as many as 20,000 participants at up to 100 sites across the US, with the potential for additional sites globally.