New Blood Test for Early Detection of Colorectal Cancer Approved by FDA

HI INDIA NEWS DESK

The Food and Drug Administration on Monday approved Guardant Health’s blood test, called Shield, to screen for colon cancer. The test isn’t meant to replace colonoscopies, but is generating enthusiasm among doctors who say it has the potential to boost the dismal rate of screenings for the second-highest cause of cancer death in the United States.
Shield, previously available to doctors for $895, is now likely to be covered by Medicare and private insurance following FDA approval, making it more accessible. Dr. Arvind Dasari from the University of Texas MD Anderson Cancer Center called the approval a “welcome development” but cautioned about its impact on screening and mortality.

The American Cancer Society (ACS) estimates over 53,000 colorectal cancer deaths this year. Research in March showed Shield is 83% effective at detecting colorectal cancers by identifying DNA from tumors in the bloodstream, particularly in later-stage cancers. However, it detected only 13% of early-stage polyps.

Shield should be administered every three years starting at age 45. A positive result necessitates a colonoscopy to confirm cancer and locate tumors. Robert Smith of the ACS emphasized that a colonoscopy is essential following a positive Shield test.

Colon cancer in people under 55 has been rising by 1-2% annually since the mid-1990s, while cases in those over 60 have declined. Screening rates are low, with less than 60% compliance among eligible people. Dr. Sapna Syngal of Dana-Farber Cancer Center believes Shield could increase screening rates significantly. Dr. William Grady noted adults in their 40s and 50s are often the least compliant due to busy lives and the unpleasantness of colonoscopy preparation. A blood test like Shield could be more acceptable to many.