Bringing AI to Colorectal Cancer Screening

Industry news | 28 June, 2018 | CACLP

Freenome has initiated a clinical study tohelp bring an AI-Genomics blood test for colorectal cancer to the U.S. market.

Freenome is looking to build a diagnostictest that can learn from its mistakes. The South San Francisco, CA- basedcompany is using artificial intelligence to improve colorectal cancerscreening.

To do this, Freenome has initiatedAI-EMERGE, a clinical study for the AI-Genomics blood test, which will collectsamples from up to 3,000 patients in the U.S. and Canada.

Freenome CEO, Gabe Otte said the infusionof AI is a natural step in the evolution of diagnostics that should have beentaken years ago.

“If you look at the traditional moleculardiagnostic tests that are out there – the PSA tests for example – you’ve seenthat when they’ve launched they had a set of accuracy numbers on a certainamount,” Otte told, MDDI. “Over time as these tests have been on themarket longer and longer that performance has dropped drastically. It’s notthat the test got worse over time once it launched to the market. It’s the factthat we didn’t account for everything on the false positive side.”

He added, “If we want to essentially beable to have a diagnostic that doesn’t have those kinds of caveats we need tobe able to build the next generation of diagnostics – a diagnostic that canlearn over time and actually improve upon itself. That’s where the AI componentreally comes in here.”

The company is hoping to complete the studyby the first quarter of 2019.

“We will do a follow-up study that islarger that will take us through to FDA approval for Centers for Medicare andMedicaid services coverage of our test,” Otte said.

One of the major forces in colorectalscreening is Exact Sciences. The Madison WI-based company received FDA approval in 2014 for the Cologuard, which detects the presence of hemoglobin and biomarkersin DNA cells shed by large polyps as stool moves through the large intestineand rectum.

“Exact Sciences is definitely a competitorand a company that has done really well educating the market and making surethey show proof for their tests,” Otte said. “In a lot of ways as we think ofthe regulatory challenges and as we think of how we get reimbursement, we lookto Exact Sciences and what they did with Cologuard as a model.”

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