Guardant  Health, Inc. (Nasdaq: GH), a leading precision oncology company, today  announced the U.S. Food and Drug Administration (FDA) has approved the  company’s Shield™ blood test for colorectal cancer (CRC) screening in  adults age 45 and older who are at average risk for the disease. It is  the first blood test to be approved by the FDA as a primary screening  option for CRC, meaning healthcare providers can offer Shield in a  manner similar to all other non-invasive methods recommended in  screening guidelines. Shield is also the first blood test for CRC  screening that meets the requirements for Medicare coverage.

Read More: https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Healths-Shield-Blood-Test-Approved-by-FDA-as-a-Primary-Screening-Option-Clearing-Path-for-Medicare-Reimbursement-and-a-New-Era-of-Colorectal-Cancer-Screening/default.aspx

Shield™ early colorectal cancer screening is a non-invasive blood  test that allows for early detection of colorectal cancer. It utilizes a  multimodal approach, integrating genomics, epigenomics, and proteomics,  to provide highly sensitive and specific detection of early signs of  colorectal cancer in average-risk adults aged 45 and above.

In validation studies, Shield demonstrated a sensitivity of 91% for   colorectal cancer and a sensitivity of 20% for advanced adenomas, with a   specificity (true negative rate) of 92% in normal cases.

ECLIPSE  is a registered study involving over 12,750 patients, aiming  to  further validate the effectiveness of this technology in detecting   early signs of colorectal cancer in average-risk adults.

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