Summary:
Labcorp has launched a nationwide blood-based biomarker test, the pTau-217/Beta Amyloid 42 Ratio, to aid in diagnosing Alzheimer’s disease, providing a less invasive alternative to PET and CSF testing.

Key Takeaways:

  1. The test offers results comparable to PET imaging and cerebrospinal fluid testing, streamlining Alzheimer’s diagnosis.
  2. Alzheimer’s cases in the U.S. are expected to nearly double by 2050, increasing the need for faster diagnostic methods.
  3. Labcorp’s new test aims to reduce diagnostic delays, easing the burden on patients and families.

Labcorp, a global provider of innovative and comprehensive laboratory services, has announced the nationwide launch of its pTau-217/Beta Amyloid 42 Ratio, a powerful new blood-based biomarker test to aid in the diagnosis of Alzheimer’s disease. The new test further expands Labcorp’s leading blood-based biomarker portfolio for Alzheimer’s disease and dementia.

Blood-Based Biomarker Test Is Comparable to PET and CSF Testing

The pTau-217/Beta Amyloid 42 Ratio supports neurologists, dementia specialists and their patients by offering results that are comparable to positron emission tomography (PET) imaging and cerebrospinal fluid (CSF) testing obtained through lumbar puncture. Labcorp’s blood-based biomarker test meets performance criteria to confirm the presence of amyloid pathology consistent with Alzheimer’s disease, and, in connection with clinical findings, supports an accelerated path to diagnosis in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline.

Alzheimer’s Diagnoses Expected to Double by 2050

An estimated 6.9 million Americans are living with Alzheimer’s disease, a number expected to nearly double by 2050. The average time between onset of symptoms and diagnosis of Alzheimer’s disease is approximately 2.8 years. Today, an Alzheimer’s diagnosis often involves amyloid PET imaging and invasive CSF testing, which can be costly, time-consuming and uncomfortable.

“For too many patients and their families, the journey from symptoms to diagnosis of Alzheimer’s disease can be long, difficult and uncertain,” says Brian Caveney, MD, Labcorp’s chief medical and scientific officer. “Our pTau-217/Beta Amyloid 42 Ratio is a significant breakthrough, improving the diagnostic process for a complex disease. This test has the potential to reduce the time and anxiety associated with identifying Alzheimer’s disease, enabling patients and their families to make more timely and informed treatment decisions.”

Key Features of Labcorp’s pTau-217/Beta Amyloid 42 Ratioi

  • An immunoassay measuring two distinct blood-based biomarkers known as indicators of Alzheimer’s disease: pTau-217 and Beta Amyloid 42, in ratio.
  • Offers a sensitivity and specificity of 95%, which is substantially equivalent to the performance of amyloid PET imaging and CSF testing.
  • Patient blood draws can be completed in a physician’s office or any of Labcorp’s more than 2,000 Patient Service Centers (PSCs) nationwide.
  • Available for use in clinical trials in addition to clinical patient care.

Featured Image: Labcorp

Reference

i This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. This test is not intended as a screening test for Alzheimer’s disease in asymptomatic individuals.