Guardant Well being has not too long ago introduced that its Protect blood take a look at has been authorized by the FDA as a brand new technique to display screen and search for indicators of colorectal most cancers (CRC) in adults aged 45 and older who’re at common danger. This marks a medical milestone as being the first-ever blood take a look at to be granted the FDA’s approval.
The Guardant Protect take a look at might be a noninvasive, handy various to the extra generally carried out strategies like colonoscopy. Colonoscopies are usually disagreeable for many, and that continues to be a motive many keep away from having the process carried out. This new blood take a look at is anticipated to enhance screening charges, which presently stand at solely 59% within the U.S., effectively beneath the Nationwide Colorectal Most cancers Roundtable’s aim of 80%.
“The FDA approval of the Protect take a look at is a major victory for sufferers and an vital milestone in Guardant Well being’s mission to beat most cancers with knowledge. Protect can assist enhance colorectal most cancers screening charges so we will detect extra cancers at an early stage, when they’re treatable. We at the moment are on the brink of launch this take a look at within the close to future and are very excited to empower physicians with a viable blood-based screening choice to tailor the screening routine to the distinctive wants of their sufferers.”
AmirAli Talasaz, Guardant Well being co-CEO through Guardant Well being Press Launch
Colorectal most cancers stays a number one reason for cancer-related deaths within the U.S., however early detection considerably boosts survival charges for these identified. Protect, with a demonstrated 83% sensitivity for CRC detection and 90% specificity for superior neoplasia, has proven excessive affected person adherence since its introduction in Might 2022. This new take a look at additionally meets Medicare protection necessities.
In line with the Related Press, the take a look at detects DNA fragments launched by tumor cells and precancerous growths. A research printed in March recognized 83% of cancers utilizing this take a look at however detected only a few of the precancerous growths with a colonoscopy, which is taken into account the “gold normal for colon most cancers screening.” The take a look at didn’t determine 17% of cancers, a efficiency stage much like that of stool-based exams.
Guardant Well being plans to launch Protect quickly and can focus on the approval in an investor convention name on July 29, 2024. The take a look at, accessible by prescription, is anticipated to be lined for Medicare beneficiaries and doubtlessly for these with industrial insurance coverage as pointers evolve.
