Guardant's (GH.US) colorectal cancer screening method Shield has been approved by the FDA and is expected to be included in Medicare.
Guardant Health (GH.US) said its blood test for detecting colorectal cancer or rectal cancer has been approved by the US Food and Drug Administration (FDA) and is moving towards being covered by Medicare in the US.
Shares of the company rose nearly 7% on Monday to close at $35.28, boosted by the news.
The test is approved for adults aged 45 and above with an average risk of colorectal cancer.
Colonoscopy is considered the “gold standard” for screening for colorectal cancer, but colonoscopy rates remain low due to barriers such as inconvenience.
“Many people don’t get screened for various reasons, and we don’t have the ability in the US to screen more people through colonoscopy,” said AmirAli Talasaz, Guardant’s chief executive.
Guardant’s test, called Shield, has been available in the US since 2022 for $895, not including Medicare coverage.
Talasaz expects Shield to be commercially available soon and added that the test would immediately qualify for Medicare coverage for people aged 65 and above because it meets the regulatory criteria for health plans.
Guardant did not disclose the price of the Shield version approved by the FDA.
In terms of cancer screening, blood tests are easier than stool tests, such as the Cologuard test by Exact Sciences (EXAS.US).
A study showed that the Guardant Shield test detected 83% of colorectal cancer, according to an FDA document. The Cologuard test by Exact Sciences detected 92.3% of colorectal cancer.
According to the FDA, about 150,000 people are diagnosed with colorectal cancer in the US each year, making it the second-leading cause of cancer deaths in the US.
William Blair analyst Andrew Brackmann said: “The focus is now shifting to the commercialisation of Shield, which will be a long and expensive process in primary care.”