A new Labcorp technique for early detection of Alzheimer鈥檚 disease for adults ages 50 and older has become available nationwide, the Burlington company announced recently.
The Food and Drug Administration has authorized the use of the blood-based in-vitro diagnostic test that works by testing the amyloid plaques associated with the disease in certain patients.
The test has been developed by Fujirebio Diagnostics Inc.
The test is being focused on specialized care settings with patients showing potential signs and symptoms of cognitive decline.
鈥淚t is not intended as a screening or stand-alone diagnostic test and must be interpreted in conjunction with other clinical information of the patient,鈥� Labcorp cautioned.
An estimated 6.7 million Americans are currently living with Alzheimer鈥檚 disease, a figure projected to more than double to 13.8 million by 2060.
Labcorp said the test 鈥渙ffers results that are comparable to existing methods that support a diagnosis of Alzheimer鈥檚 disease 鈥� cerebrospinal fluid testing obtained through lumbar puncture and positron emission tomography scans.鈥�
The new test involves a blood draw, 鈥渕aking it more affordable, more accessible and less invasive,鈥� Labcorp said.
Fujirebio reports that in clinical studies, the test demonstrated a positive predictive value of 92% and a negative predictive value of 97%.
鈥淭he path to an Alzheimer鈥檚 diagnosis has long meant a diagnostic journey requiring years of invasive procedures and expensive imaging,鈥� said Dr. Brian Caveney, chief medical and scientific officer at Labcorp.
鈥淐linicians need better ways to diagnose their patients more quickly, enroll them in clinical trials or start therapies.
鈥淏y offering this FDA-cleared blood test nationwide, Labcorp is leading the way in delivering innovative solutions for Alzheimer鈥檚 disease and other neurological conditions by helping patients, families and physicians get answers sooner.鈥�
The launch of this test closely follows the release of a new clinical guideline from the Alzheimer鈥檚 Association, which supports the use of blood-based biomarkers to help evaluate patients suspected of Alzheimer鈥檚 disease in specialty care settings.
The guideline highlights the growing clinical consensus around these tools and reinforces the importance of expanding access.
鈥淥nce ordered, patients can complete the blood draw in a health care provider鈥檚 office or any of Labcorp鈥檚 more than 2,200 patient service centers.鈥�
The FDA-cleared test builds on and replaces a similar pTau-217/Beta Amyloid 42 Ratio test that the company launched in April 2025.
For more information about Labcorp鈥檚 portfolio of blood-based biomarkers for Alzheimer鈥檚 disease and dementia, go to .
In March 2024, Labcorp debuted a test designed to identify the presence or absence of a pivotal blood biomarker designed to aid in the diagnosis of Alzheimer鈥檚 disease.
The test focuses on phosphorylated tau 217 (pTau217). The test also assists in the monitoring of patients undergoing treatment with new Alzheimer鈥檚 disease therapies.
The pTau217 marker has been used in Alzheimer鈥檚 drug trials to monitor patients on anti-amyloid therapy.