Labcorp is now offering Roche Diagnostics’ recently FDA-cleared Alzheimer’s disease blood test to help primary care doctors rule out the disease in people 55 and older with symptoms of cognitive decline, the company announced Feb. 11.
The diagnostic testing giant first indicated its plans to offer the minimally invasive Elecsys pTau181 test last October, shortly after the FDA cleared it for primary care use. The test also received CE mark certification last July, authorizing its sale in Europe.
The test measures phosphorylated Tau (pTau) 181 protein in the blood, which has been linked to the abnormal buildup of amyloid plaque in the brain, a hallmark sign of Alzheimer’s.
With an estimated 7.2 million people in the U.S. living with the disease—a number that’s expected to double by 2050—the new test could help expand early detection, Labcorp said in a release.
“Primary care clinicians are often the first point of contact for patients with concerns related to cognitive symptoms, yet Alzheimer’s testing has historically required a visit to a specialist,” Labcorp Chief Medical and Scientific Officer Brian Caveney, M.D., said in a statement.
“By making this first-of-its-kind blood test available nationwide, Labcorp is giving primary care clinicians a powerful tool to help patients get answers sooner and guide next steps with confidence,” he said.
Roche’s test is performed using a simple blood draw, which can be done in a doctor’s office or at one of Labcorp’s 2,200 testing sites. Patients with negative results can be evaluated for other causes of cognitive decline, while those with positive results can be referred for additional testing.
The test has a 97.9% negative predictive value and may help patients avoid more expensive or invasive tests such as brain scans and lumbar punctures, Labcorp said.
