Guardant's Blood Cancer Test Nears Medicare Coverage with FDA Approval

Guardant's blood-based cancer test has gained FDA approval, bringing it one step closer to Medicare coverage. This significant milestone in cancer detection promises improved access for patients, potentially leading to earlier and more accurate diagnosis. The test, which identifies cancer through a simple blood draw, represents a major advancement in non-invasive cancer screening, offering new hope for better patient outcomes and streamlined treatment options.

Guardant Health (GH.O) announced that its blood test for detecting cancer in the colon or rectum has received approval from the U.S. Food and Drug Administration, moving it closer to Medicare coverage.

The company's shares rose by 3.4% to $34.13 on Monday. The test is approved for adults aged 45 and older who are at average risk for colorectal cancer. Colonoscopies are considered the gold standard for cancer screening, but rates remain low due to perceived inconvenience.

"Many people avoid the procedure for various reasons, and the U.S. lacks the capacity to screen more people via colonoscopy," said Guardant CEO AmirAli Talasaz.

Guardant's test, Shield, has been available in the U.S. since 2022 for laboratory use at a self-pay price of $895, but it is not covered under Medicare. Talasaz anticipates Shield's commercial availability soon, noting it will be immediately eligible for Medicare coverage for those aged 65 and above, meeting criteria set by the regulating agency.

Guardant did not disclose the self-pay price of the FDA-approved Shield version. Blood-based tests are more convenient than feces-based tests like Exact Sciences' Cologuard for cancer screening.

According to FDA documents, a study showed Guardant's Shield test detected 83% of colorectal cancers, while Exact Sciences' Cologuard had a 92.3% sensitivity rate. Colorectal cancer affects about 150,000 people in the U.S. annually and is the second-leading cause of cancer deaths in the country, according to the FDA.

"The focus now turns to commercialization for Shield, which will be a long and costly process in primary care," said William Blair analyst Andrew Brackmann.

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Source: Reuters‍