Delfi Diagnostics is launching its first liquid biopsy test, fulfilling the company’s own, years-long prophecy to offer a new blood-based tool for the screening of lung cancer.
Its Firstlook Lung test aims to provide a more convenient detection method and one that’s capable of reaching a greater number of people than the current standard—with a single blood draw being an inexpensive and easy-to-take first step for a population at risk, such as those with a long history of smoking.
Its ultimate objective is to help identify those who should receive the extra attention provided by a low-dose chest CT scan and to funnel them toward confirmation of the presence of a tumor—similar to how at-home stool DNA tests like Exact Sciences’ Cologuard have served as a gateway to getting people on the track for a more-thorough colonoscopy.
“The data supporting lung screening are as strong as it is in any cancer screening setting,” Peter Bach, M.D., Delfi’s chief medical officer, said in an interview. “It’s the largest cancer killer, and probably the biggest opportunity to save lives through screening in the U.S.—and there’s essentially no uptake of low-dose CT scans.”
“The latest data suggest about 6% of people—so just under a million out of the 15 million that are eligible—are getting these scans annually.” Bach added. “So we see this as a really important opportunity: What the more-accessible [fecal immunochemical test] is for colorectal cancer screening, we want to be for lung cancer screening.”
That means a slightly different use case compared to other liquid biopsy tests being developed, which may aim to catch tumor DNA in the bloodstream, analyze it for specific mutations and help narrow down a diagnosis and proper treatment. While those tests may put weight on achieving a highly accurate positive result, Delfi’s Firstlook Lung focuses on the negative—namely that, when it’s rolled out to screen a large population of people, a clinician can trust a negative result has most likely ruled out the presence of a hidden cancer.
According to the former Fierce 15 winner, the test’s sensitivity was able to deliver a negative predictive value of 99.7%, or a 3-in-1,000 chance of a person having lung cancer and a negative result.
Firstlook Lung was built on Delfi’s machine-learning-powered platform, which analyzes the millions of data points that come with how DNA strands are packaged, broken up and released into the bloodstream by tumor cells. While healthy cells may keep their genomes orderly, the chaotic, endless division and reproduction of cancer leads to DNA that’s been fragmented in messy, detectable patterns.
This platform, combining wet lab chemistry and DNA sequencing with digital programs, will also serve as the foundation for Delfi’s future offerings—including plans to explore its tests’ potential in other tumors, such as liver cancer, or in other applications entirely, such as monitoring the blood for signs of residual disease after surgery and treatment.
“In this particular case we have a fantastic product, but it’s clear there’s a lot of headroom for this technology to continuously improve over time,” said founder and CEO Victor Velculescu, M.D., Ph.D., on Delfi’s vision of the future.
“This platform is essentially the same in all cancers,” Velculescu said. “We’re very optimistic that this will allow the development of these tests for other cancer types to be much faster than it has historically been. We think we can get to additional products very quickly.”
Delfi’s commercial launch was announced alongside presentations at the HLTH conference in Las Vegas and the annual meeting of the American College of Chest Physicians in Honolulu. The company plans to start off Firstlook Lung as a lab-developed test within a select number of U.S. health systems this fall.