(Reuters) -The U.S. Meals and Drug Administration authorized Guardant Well being’s blood take a look at on Monday to detect a most cancers that begins within the colon or rectum.
The take a look at, often known as Defend, has been accessible within the U.S. as a laboratory-developed take a look at since 2022.
Advisers to the FDA voted to approve the blood take a look at in Could, with the regulator permitting its use for adults aged 45 years and older.
The FDA approval takes it a step nearer to probably changing into the primary take a look at for colorectal most cancers (CRC) screening to be eligible for Medicare insurance coverage protection for older adults.
Blood-based checks are extra handy than feces-related checks, equivalent to Actual Sciences’ Cologuard, for most cancers screening.
Defend’s approval is the second for a blood-based take a look at for CRC screening in america after Epigenomics’ Epi proColon, which was authorized in 2016.
Nevertheless, Epi proColon was not chosen for Medicare protection as a result of it didn’t meet the Facilities for Medicare & Medicaid Providers (CMS) standards of 74% or extra sensitivity.
Based on the FDA’s paperwork, a examine confirmed Guardant’s Defend take a look at detected 83% of colorectal cancers. Actual Sciences’ stool take a look at Cologuard had a 92.3% sensitivity price.
Colonoscopy is taken into account the gold normal take a look at for CRC, and is used for its prognosis.
CRC happens in about 150,000 sufferers within the U.S. yearly and is the second-leading explanation for most cancers fatalities within the nation, with greater than 50,000 deaths annually, based on the FDA.
(Reporting by Sneha S Okay, Leroy Leo and Sriparna Roy in Bengaluru; Modifying by Shounak Dasgupta)