Bay Area biotech Guardant Health announced the commercial launch of its early-detection colon cancer test on Monday, marking the latest twist in an escalating race to spot cancer sooner and more accurately.
The company’s test, known as Shield, is available to adults 45 and older who aren’t up to date with current screening guidelines, don’t have symptoms, and are at average risk of colon cancer. Shield is a lab-developed test, meaning that it hasn’t been approved by the Food and Drug Administration and that each sample (about a tablespoon of blood) must be sent to Guardant’s lab.
That could change soon, says co-CEO AmirAli Talasaz, who notes that Guardant will announce data around the middle of this year from a clinical trial measuring how accurately Shield detects colon cancer in those who have the disease but don’t yet have symptoms. The biotech plans to use those results to seek FDA approval and Medicare reimbursement for the test. That would put the company one step closer to reaching a target population of 130 million individuals 45 to 84 years old.
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