Overview
- The FDA authorized marketing of Fujirebio’s Lumipulse G pTau217/Aβ1-42 test with distribution to 37 US memory clinics, including Mayo Clinic, by the end of June.
- A Mayo Clinic study of over 500 patients demonstrated the test’s 95% sensitivity and 82% specificity in detecting amyloid and tau protein markers.
- Researchers report the blood-based assay matches the accuracy of lumbar punctures and PET scans while offering a less invasive and lower-cost option.
- Next steps include validating the test in individuals without cognitive symptoms and in more diverse populations to ensure wide applicability.
- The UK’s Blood Biomarker Challenge aims to introduce comparable blood diagnostics into the NHS by 2029 to support a growing pipeline of dementia therapies.