Key Takeaways
- Guardant Health’s colon cancer screening “Shield” blood test has been approved by the FDA.
- According to the company, SHIELD is the first blood test approved by the FDA as a primary screening option for colorectal cancer.
- Guardant Health shares rose in intraday trading on Monday on the news.
Guardant Health (GH) shares rose on Monday after the company announced that its Shield colon cancer screening blood test has received U.S. Food and Drug Administration (FDA) approval.
According to the company, SHIELD is the first blood test approved by the FDA as a primary screening test for colon cancer and the first to meet Medicare coverage requirements for average-risk adults age 45 and older.
FDA approval a ‘big win’
“The FDA approval of the SHIELD test is a major win for patients and a key milestone in Guardant Health’s mission to defeat cancer with data,” said co-CEO Amir-Ali Tarazaz. “SHIELD will help improve colon cancer screening rates, allowing us to detect more cancers at an earlier, treatable stage.”
According to the company, one study showed that the Shield test had an 83% sensitivity for detecting colorectal cancer and a 90% specificity for aggressive tumors.
Guardant Health shares were up 3% to $34.00 as of 2:15 p.m. ET on Monday and are up 25% this year.
