Freenome is looking to build a diagnostic test that can learn from its mistakes. The South San Francisco, CA- based company is using artificial intelligence to improve colorectal cancer screening.
To do this, Freenome has initiated AI-EMERGE, a clinical study for the AI-Genomics blood test, which will collect samples from up to 3,000 patients in the U.S. and Canada.
Freenome CEO, Gabe Otte said the infusion of AI is a natural step in the evolution of diagnostics that should have been taken years ago.
“If you look at the traditional molecular diagnostic tests that are out there – the PSA tests for example – you’ve seen that when they’ve launched they had a set of accuracy numbers on a certain amount,” Otte told, MDDI. “Over time as these tests have been on the market longer and longer that performance has dropped drastically. It’s not that the test got worse over time once it launched to the market. It’s the fact that we didn’t account for everything on the false positive side.”
He added, “If we want to essentially be able to have a diagnostic that doesn’t have those kinds of caveats we need to be able to build the next generation of diagnostics – a diagnostic that can learn over time and actually improve upon itself. That’s where the AI component really comes in here.”
The company is hoping to complete the study by the first quarter of 2019.
“We will do a follow-up study that is larger that will take us through to FDA approval for Centers for Medicare and Medicaid services coverage of our test,” Otte said.
One of the major forces in colorectal screening is Exact Sciences. The Madison WI-based company received FDA approval in 2014 for the Cologuard, which detects the presence of hemoglobin and biomarkers in DNA cells shed by large polyps as stool moves through the large intestine and rectum.
“Exact Sciences is definitely a competitor and a company that has done really well educating the market and making sure they show proof for their tests,” Otte said. “In a lot of ways as we think of the regulatory challenges and as we think of how we get reimbursement, we look to Exact Sciences and what they did with Cologuard as a model.”