In a significant development in cancer diagnostics, Guardant Health announced that its blood test designed to detect colorectal cancer has received approval from the U.S. Food and Drug Administration (FDA). This approval brings the test, known as Shield, one step closer to being included in the country's Medicare insurance program.

The FDA-approved Shield test is specifically intended for adults aged 45 and older who have an average risk of developing colon or rectal cancer. While colonoscopies are considered the gold standard for screening, the low screening rates are attributed to factors such as inconvenience and other concerns.

Guardant CEO AmirAli Talasaz emphasized the need for alternative screening methods, stating, "Many people for different reasons are not going through that [colonoscopy] procedure, and in the United States, we don't have a lot more capacity to screen a lot more people through colonoscopy either."

Shield has been available in the United States since 2022 for use by laboratories, at a self-pay price of $895. However, it is not currently covered by Medicare. Talasaz anticipates that Shield will be commercially available in the near future and would be eligible for Medicare coverage for individuals aged 65 and above, meeting the criteria outlined by the health plans regulatory agency.

While Guardant did not disclose the self-pay price for the FDA-approved version of the Shield test, the company aims to provide a more convenient and accurate screening option for colorectal cancer compared to existing methods. Blood-based tests, like Shield, have an advantage over feces-based tests, such as Exact Sciences' Cologuard, in terms of convenience.

According to documents from the FDA, a study showed that Guardant's Shield test detected 83% of colorectal cancers, while Exact Sciences' Cologuard had a sensitivity rate of 92.3%. Colorectal cancer affects approximately 150,000 patients in the United States annually and ranks as the second-leading cause of cancer-related deaths in the country.

Looking ahead, the focus now shifts to the commercialization of Shield, which is expected to be a challenging and costly process in primary care, according to William Blair analyst Andrew Brackmann.

Guardant Health's FDA-approved blood test brings renewed hope in the early detection of colorectal cancer, potentially enabling more individuals to access screening and improve their chances of successful treatment.