NEW YORK – Cancer early detection firm Delfi Diagnostics said on Wednesday that it has begun recruiting for a 1,700-person prospective multi-center case control trial of its lung cancer liquid biopsy screening test. The company has also received Breakthrough Device Designation for the test from the US Food and Drug Administration.
The trial will measure the performance of Delfi's test in patients already diagnosed with lung cancer as well as in demographically matched presumably healthy individuals. Delfi plans to launch multiple prospective trials to gather the clinical data for launching the test commercially for lung cancer screening, followed by other cancer types.
Delfi also said that it has partnered with NYU Langone to investigate additional applications for the platform in specific populations, such as non-smoking Asian women, where improved early detection of lung cancer could reduce mortality but cancer screening is not currently recommended.
Breakthrough designation provides a company with additional access to feedback during the evidence development process and ensures expedited review from FDA when an application for approval or clearance is submitted.
According to Delfi, current guidelines recommend annual lung cancer screening by low-dose CT scans for at-risk individuals, a population of approximately 15 million US adults. But due to access and adherence barriers, fewer than 10 percent of that group actually receive this recommended screening.
Delfi's technology uses advanced machine learning algorithms to analyze genome-wide cell-free DNA fragmentation profiles from a simple blood draw.
"We think there is a clear unmet need to improve acceptability and access while decreasing risks of lung cancer early detection," Douglas Wood, a thoracic surgeon and chair of the surgery department at the University of Washington, said in a statement.
"The average five-year survival for patients with early-stage lung cancer is roughly 10 times greater than for patients that are diagnosed with late-stage disease and we just aren't catching enough of these cases early. An affordable, high performance, broadly available blood test could help increase screening rates and reduce overall lung cancer mortality," he added.