Guardant Health's stock up after FDA approves its blood test for colon-cancer screening

By Ciara Linnane

Test called 'Shield' is first to be approved in the U.S. and first to meet requirements for Medicare coverage

Guardant Health Inc.'s stock rose 2.4% Monday, after the company said the Food and Drug Administration has approved its blood test for colon-cancer screening in adults 45 and older who are at average risk for the disease.

It's the first such blood test to receive regulatory approval in the U.S. and the first that meets the requirements for Medicare coverage, the Palo Alto, Calif.-based company (GH) said in a statement.

The test, called Shield, is expected to offer clear benefits as colon cancer is highly treatable if caught early. Colon, or colorectal cancer to give it its full name, is the second-leading cause of cancer-related death in the U.S., with more than 150,000 diagnoses expected in 2024 and more than 53,000 deaths.

"More than three out of four individuals who die from CRC are not up to date with their screening," Guardant said. "Early detection is critical."

The five-year relative survival rate is 91%, when the cancer is quickly detected, a rate that falls to 14% if it spreads to other parts of the body.

The current screening rate is about 59%, below the National Colorectal Cancer Roundtable's goal of 80% for eligible individuals. Most screening is done by stool-based tests or colonoscopy, which many find invasive and unpleasant.

"This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era," Dr. Daniel Chung, a gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, said in prepared remarks.

The FDA approval was based on a study involving more than 20,000 patients at more than 200 clinical sites in rural and urban communities in 37 states.

Guardant's stock has gained 25% in the year to date, while the SPDR S&P Biotech ETF XBI has gained 12% and the S&P 500 SPX has gained 15%.

-Ciara Linnane

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07-30-24 0814ET

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