Bay Area biotech Guardant Health on Thursday announced results from a massive trial of its blood-based test for the early detection of colon cancer that, while good enough for Medicare reimbursement, underwhelmed observers.
The company announced that a study of more than 20,000 people, dubbed ECLIPSE, detected colon cancer 83% of the time it was actually there and correctly returned a negative result 90% of the time — characteristics of a test known as sensitivity and specificity, respectively. But those results disappointed market observers, who noted that earlier and smaller studies indicated the test, known as Shield, would spot 91% of colorectal cancer cases and correctly return negative results 92% of the time.
Both the company and market analysts point out that these results still meet the bar that the Centers for Medicare & Medicaid Services has set for reimbursing such a test: sensitivity of 74% and specificity of 90%. And Guardant is planning to apply in the first quarter of next year for Food and Drug Administration approval of Shield, which is currently offered as a lab-developed test.
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