Labcorp (NYSE:LH) announced Monday the nationwide availability of the Lumipulse pTau-217/Beta Amyloid 42 Ratio, the first blood-based test cleared by the U.S. Food and Drug Administration to aid in diagnosing Alzheimer’s disease.
The test, developed by Fujirebio Diagnostics, Inc., detects amyloid plaques associated with Alzheimer’s through a simple blood draw, offering a less invasive alternative to traditional diagnostic methods such as cerebrospinal fluid testing and PET scans.
According to clinical studies cited in the press release, the test demonstrated a positive predictive value of 92% and a negative predictive value of 97%.
"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.
The test is intended for adults aged 50 and older who show signs of cognitive decline in specialized care settings. It is not designed as a standalone diagnostic tool and must be interpreted alongside other clinical information.
This launch follows the recent release of new clinical guidelines from the Alzheimer’s Association supporting the use of blood-based biomarkers for evaluating patients suspected of having Alzheimer’s disease in specialty care settings.
Patients can access the test through a healthcare provider’s order and complete the blood draw at any of Labcorp’s more than 2,200 Patient Service Centers nationwide.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.