Fujirebio has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test.
The test is designed to assess amyloid pathology in patients being evaluated for Alzheimer’s disease (AD) and other cognitive decline causes.
It is the first FDA-cleared blood-based IVD test in the US to aid in identifying patients with amyloid pathology linked to AD, said the company.
The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test offers an accurate and minimally invasive method to measure pTau 217 and β-Amyloid 1-42 concentrations in plasma. This measurement serves as a proxy for detecting β-Amyloid plaque pathology in the brain.
The test is intended for adults aged 50 and older who exhibit cognitive decline symptoms in specialised care settings. In a clinical study involving 499 participants, which reflected US demographics, the test achieved a positive predictive value of 92% and a negative predictive value of 97%. Only 20% of patients were uncertain to have amyloid pathology, necessitating further testing.
Fujirebio’s Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test operates on the fully automated LUMIPULSE G1200 instrument system, which is prevalent in clinical laboratories across the US.
The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), which the FDA authorised for cerebrospinal fluid use in May 2022.
Fujirebio Diagnostics president and CEO Monte Wiltse said: “The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment.
“The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective. “As part of our worldwide commitment to improve the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.”
