Labcorp has launched the Lumipulse pTau-217/Beta Amyloid 42 Ratio, the first blood test approved by the US Food and Drug Administration (FDA) for diagnosing Alzheimer’s disease (AD).
Developed by Fujirebio Diagnostics, a US-based developer of in-vitro diagnostic (IVD) solutions, the test detects amyloid plaques associated with AD.
It provides a less invasive and more accessible alternative to traditional methods, such as cerebrospinal fluid testing and positron emission tomography (PET) scans.
The Lumipulse test is intended for adults aged 50 years and above, with cognitive decline symptoms, used alongside other clinical assessments.
Patients can access the test at healthcare facilities or any of Labcorp’s over 2,200 centres across the US.
Labcorp chief medical and scientific officer Brian Caveney said: “The path to an Alzheimer’s diagnosis has long meant a diagnostic journey requiring years of invasive procedures and expensive imaging.
“Clinicians need better ways to diagnose their patients more quickly, enrol 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.”
Labcorp said the launch aligns with the Alzheimer’s Association’s recent endorsement of blood-based biomarkers for the evaluation of AD.
The Lumipulse test combines pTau-217 and Beta Amyloid 42 for enhanced accuracy and provides a cost-effective solution.
In clinical studies, the test showed a positive predictive value of 92% and a negative predictive value of 97% in identifying amyloid pathology linked to AD.
Earlier this year, Labcorp secured the CE mark for its PGDx elio tissue complete solution under the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR).
PGDx elio tissue complete is a qualitative next-generation sequencing (NGS)-based in vitro diagnostic device that enhances personalised cancer care in the EU.
