The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) test for evaluating amyloid pathology in individuals under assessment for Alzheimer’s disease and other cognitive decline causes.
The test claims to be the first blood-based IVD test in the country cleared by the regulator to help detect those with amyloid pathology associated with the illness.
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According to the company, this test offers a minimally invasive and accessible pTau 217 and β-Amyloid 1-42 concentration measurement in plasma, serving as an indicator of β-Amyloid plaque pathology presence in the brain.
Intended for use in adults aged ≥ 50 years presenting with cognitive decline symptoms, the test was evaluated in a clinical trial of 499 subjects, reflecting US demographics, and using a dual cut point.
In the trial, it showed positive and negative predictive values of 92% and 97%, respectively, with 20% of subjects needing further testing for amyloid pathology.
It operates using the company’s fully automated LUMIPULSE G1200 instrument system.
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By GlobalDataThe new ratio test reportedly complements the previously FDA-authorised Lumipulse G β-Amyloid Ratio (1-42/1-40) for use in cerebrospinal fluid (CSF), in May 2022.
The agency noted that the test measures the levels of two proteins, pTau217 and β-amyloid 1-42, in human plasma and calculates their ratio.
This ratio correlates with the presence or absence of amyloid plaques in the patient’s brain, potentially minimising the requirement of a positron emission tomography (PET) scan.
Fujirebio Diagnostics CEO and president Monte Wiltse said: “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 Alzheimer’s 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.”
Last July, Fujirebio introduced the Lumipulse G GFAP assay in the US, a neurological research tool tailored for measuring glial fibrillary acidic protein (GFAP).
