Guardant's blood-based cancer test moves closer to Medicare coverage with FDA approval

By Leroy Leo

(Reuters) - Guardant Health said its blood test to detect cancer that starts in the colon or rectum got an approval from the U.S. Food and Drug Administration, with the test moving closer toward gaining coverage under the country's Medicare insurance program.

The company's shares were up 3.4% at $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 test, but screening rates for the type of cancer remain low due to issues such as their perceived inconvenience.

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

Guardant's test, known as Shield, has been available in the U.S. since 2022 for use by laboratories, for a self-pay price of $895, but is not covered under Medicare.

Talasaz expects Shield to be commercially available in the near future, adding that the test would be immediately eligible under Medicare coverage for ages 65 and above as it meets criteria outlined by the agency that regulates the health plans.

Guardant did not provide the self-pay price of the FDA-approved version of Shield.

Blood-based tests are also more convenient than feces-based tests, such as Exact Sciences' Cologuard, for cancer screening.

According to the FDA's documents, a study showed Guardant's Shield test detected 83% of colorectal cancers. Exact Sciences' stool test Cologuard had a 92.3% sensitivity rate.

Colorectal cancer occurs in about 150,000 patients in the U.S. annually and is the second-leading cause of cancer fatalities in the country, according to the FDA.

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

(Reporting by Sneha S K, Leroy Leo and Sriparna Roy in Bengaluru; Editing by Shounak Dasgupta)