NEW YORK – Guardant Health said Monday that the US Food and Drug Administration had approved its Guardant Shield assay as a primary colorectal cancer screening option, following an FDA advisory committee meeting in May that concluded with a majority recommendation.
Data considered by the committee came from Guardant's ECLIPSE study, which enrolled more than 20,000 patients, demonstrating 83 percent sensitivity for the detection of CRC, with 90 percent specificity.
The blood-based test is now approved for use in adults aged 45 and older who are at average risk for CRC. With the FDA's nod, Shield now meets requirements for coverage established by the Centers for Medicare and Medicaid Services in a 2021 national coverage determination.
Guardant has been offering Shield as a laboratory-developed test since May 2022, and has said that more than 90 percent of patients offered the test clinically have completed it. According to the company, prior studies have shown that when patients are offered other clinically available tests, which include stool-based options and colonoscopy, the maximum number that actually comply is around 70 percent.
Shield enables primary care physicians to initiate screening with a simple blood draw during a routine office visit.
A lingering question for Guardant has been whether the FDA's label for Shield would contain specific language around the test's lower sensitivity for cancer precursor lesions known as advanced adenomas.
In a note to investors, Dan Brennen of investment bank TD Cowen said that the language in the newly minted label is "a bit more strongly worded" on the test's stage I and adenoma detection than expected.
The label cautions doctors and patients that "Based on data from clinical studies, Shield has limited detection (55 percent to 65 percent) of Stage I colorectal cancer and does not detect 87 percent of precancerous lesions. One out of 10 patients with a negative Shield result may have a precancer that would have been detected by a screening colonoscopy."
In another note, Vijay Kumar of investment bank Evercore said that while Medicare's requirements have been met, future commercial payor coverage could rest more on the US Preventive Services Task Force's take, which could put more weight on adenoma detection.
He added that the approval nevertheless bodes well for other companies expected to enter the market for blood-based CRC screening, including Freenome, which recently presented its own pivotal data, and Exact Sciences, which is expected to share results in coming months.