Guardant Health said its blood test to detect a cancer that starts within the colon or rectum got an approval from the U.S. Food and Drug Administration, sending the corporate’s shares up 16% in premarket trading on Monday.
The test, generally known as Shield, has been available within the U.S. as a laboratory-developed test (LDT) since 2022 and is on the market for a self-pay price of $895.
LDTs are designed, manufactured and used inside a single laboratory, but FDA’s approval takes Shield a step closer to becoming the primary blood test for colorectal cancer (CRC) screening that’s eligible for Medicare insurance coverage for older adults.
Guardant didn’t provide the self-pay price of the FDA-approved version of the test. If covered under certain Medicare plans for people aged 65 and older, patients normally don’t have to bear out-of-pocket cost for such tests.
Advisers to the FDA voted to approve the blood test in May, with the regulator allowing its use for adults aged 45 years and older.
Blood-based tests are more convenient than feces-based tests, akin to Exact Sciences’ Cologuard, for cancer screening.
The FDA decision helps Shield test goal greater than 50 million individuals who remain unscreened, Leerink Partners analyst Puneet Souda said.
Shield’s approval is the second for a blood-based test for CRC screening in the US after Epigenomics’ Epi proColon, which was approved in 2016 but failed to satisfy the federal government’s 74% or more sensitivity criteria for Medicare coverage.
In response to the FDA’s documents, a study showed Guardant’s Shield test detected 83% of colorectal cancers. Exact Sciences’ stool test Cologuard had a 92.3% sensitivity rate.
Colonoscopy is taken into account the gold standard test for CRC.
CRC occurs in about 150,000 patients within the U.S. annually and is the second-leading reason behind cancer fatalities within the country, with greater than 50,000 deaths every year, in keeping with the FDA.
Guardant Health said its blood test to detect a cancer that starts within the colon or rectum got an approval from the U.S. Food and Drug Administration, sending the corporate’s shares up 16% in premarket trading on Monday.
The test, generally known as Shield, has been available within the U.S. as a laboratory-developed test (LDT) since 2022 and is on the market for a self-pay price of $895.
LDTs are designed, manufactured and used inside a single laboratory, but FDA’s approval takes Shield a step closer to becoming the primary blood test for colorectal cancer (CRC) screening that’s eligible for Medicare insurance coverage for older adults.
Guardant didn’t provide the self-pay price of the FDA-approved version of the test. If covered under certain Medicare plans for people aged 65 and older, patients normally don’t have to bear out-of-pocket cost for such tests.
Advisers to the FDA voted to approve the blood test in May, with the regulator allowing its use for adults aged 45 years and older.
Blood-based tests are more convenient than feces-based tests, akin to Exact Sciences’ Cologuard, for cancer screening.
The FDA decision helps Shield test goal greater than 50 million individuals who remain unscreened, Leerink Partners analyst Puneet Souda said.
Shield’s approval is the second for a blood-based test for CRC screening in the US after Epigenomics’ Epi proColon, which was approved in 2016 but failed to satisfy the federal government’s 74% or more sensitivity criteria for Medicare coverage.
In response to the FDA’s documents, a study showed Guardant’s Shield test detected 83% of colorectal cancers. Exact Sciences’ stool test Cologuard had a 92.3% sensitivity rate.
Colonoscopy is taken into account the gold standard test for CRC.
CRC occurs in about 150,000 patients within the U.S. annually and is the second-leading reason behind cancer fatalities within the country, with greater than 50,000 deaths every year, in keeping with the FDA.
