The First FDA-Cleared Blood Test for Alzheimer’s Diagnosis Now Available on the Market

The first blood test, Lumipulse pTau-217/Aβ42, is now on the market for aiding Alzheimer’s diagnosis following FDA clearance for early detection of amyloid pathology. Developed by Fujirebio, the assay demonstrated a 92% positive predictive value and 97% negative predictive value, delivering performance comparable to PET imaging and CSF analysis—while offering a far less invasive, more accessible alternative through a simple blood draw.

Labcorp has announced the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based test cleared by the U.S. Food and Drug Administration (FDA) to assist in diagnosing cognitive symptoms of Alzheimer’s disease.

"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 by helping patients, and physicians get answers sooner.”

Until now, objective biomarker evidence for Alzheimer’s pathology largely required cerebrospinal fluid (CSF) analysis via lumbar puncture or amyloid PET imaging—accurate but invasive, costly, or difficult to access. The Lumipulse blood test is designed to detect Alzheimer’s-related pathology indirectly by quantifying plasma phosphorylated tau-217 (pTau-217) relative to beta-amyloid 42 (Aβ42).

According to Fujirebio’s clinical data, the assay showed a positive predictive value of 92% and a negative predictive value of 97%, offering performance that the company describes as comparable to CSF and PET-based approaches while being far less invasive.

The launch of this test closely follows the release of a new clinical guideline from the Alzheimer's Association, which supports the use of blood-based biomarkers to help evaluate patients suspected of Alzheimer's disease in specialty care settings. The guideline highlights the growing clinical consensus around these tools and reinforces the importance of expanding access.

The Lumipulse pTau-217/Beta Amyloid 42 Ratio is intended for adults aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. It is not intended as a screening or stand-alone diagnostic test and must be interpreted in conjunction with other clinical information of the patient. Once ordered, patients can complete the blood draw in a healthcare provider's office or any of Labcorp's more than 2,200 Patient Service Centers (PSCs) nationwide.