24/7 Market News- FDA Approves Guardant Health’s Shield Blood Test as a Primary CRC Screening Option

July 29, 2024

DENVER, Colo., Jul 29, 2024 (247marketnews.com)- Guardant Health, Inc. (NASDAQ:GH) stated that the U.S. Food and Drug Administration (FDA) approved Guardant Health’s Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease, making it the first blood test to be approved by the FDA as a primary screening option for CRC.

The approval means that healthcare providers can offer Shield as the first blood test for CRC screening that meets the requirements for Medicare coverage.

Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, stated, “The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people.

“The FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved.”

Guardant Health’s co-CEO, AmirAli Talasaz, commented, “The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable.

“We are now getting ready to launch this test in the near future and are very excited to empower physicians with a viable blood-based screening option to tailor the screening regimen to the unique needs of their patients.”

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