First FDA-cleared Alzheimer’s blood test now available from Labcorp

Burlington-based Labcorp has launched the first blood-based test cleared by the U.S. Food and Drug Administration (FDA) for aiding in the diagnosis of Alzheimer's disease. 

Available nationwide, the Lumipulse® pTau-217/Beta Amyloid 42 Ratio blood test is designed to detect amyloid plaques associated with the disease in adult patients 50 and older with signs and symptoms of the disease. 

Although amyloid plaques in a patient’s brain are a hallmark of Alzheimer’s disease, they are typically detected using positron emission tomography (PET) scans or by testing cerebrospinal fluid (CSF) acquired through a lumbar puncture. The new blood test provides similar information using only a blood draw, making it less invasive, more affordable, and easier to access.

According to Fujirebio Diagnostics Inc., which developed the test, clinical studies showed that the blood test results closely matched those from amyloid PET imaging and amyloid CSF, exhibiting a positive predictive value of 92% and a negative predictive value of 97%. 

Simplifying Alzheimer’s testing

"The path to an Alzheimer's diagnosis has long meant a diagnostic journey requiring years of invasive procedures and expensive imaging," said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. "Clinicians need better ways to diagnose their patients more quickly, enroll them in clinical trials, or start therapies. 

By offering this FDA-cleared blood test nationwide, Labcorp is leading the way in delivering innovative solutions for Alzheimer's disease and other neurological conditions by helping patients, families and physicians get answers sooner." 

The launch of the new test comes just after the Alzheimer's Association released a new clinical guideline supporting the use of blood-based biomarkers to help evaluate patients suspected of Alzheimer's disease in specialty care settings. The guideline reflects expanding clinical agreement around these tools and emphasizes the need for greater access.

The Lumipulse pTau-217/Beta Amyloid 42 Ratio is intended for adults aged 50 years and older with signs and symptoms of cognitive decline who are being seen in a specialized care setting. It is not designed for screening or as a stand-alone diagnostic tool, and results should be interpreted together with the patient’s other clinical information.

After the test is ordered, patients can have their blood drawn at a healthcare provider’s office or at a Labcorp Patient Service Center.