Beckman Coulter Licensing Alzpath's P-tau 217 Antibody for Use in Alzheimer's Blood Tests

Original from: 360dx

Alzpath said Monday that it has signed a licensing agreement with Beckman Coulter Diagnostics for use of the Alzpath phosphorylated-tau 217 antibody in a blood-based test for Alzheimer's disease.

Beckman Coulter will use the antibody as part of a p-tau 217 in vitro diagnostic on its DxI 9000 Immunoassay Analyzer to aid in the diagnosis of Alzheimer's.

Financial and other terms of the agreement were not disclosed.

P-tau 217 has emerged as an important biomarker for Alzheimer's disease, allowing clinicians to assess whether an individual has the amyloid brain pathology characteristic of the condition without requiring more expensive and invasive procedures like PET or cerebrospinal fluid testing.

Such tests are likely to play a role in qualifying patients for treatment with anti-amyloid therapies, including Eisai and Biogen's Leqembi (lecanemab), which was approved by the US Food and Drug Administration last year, and Eli Lilly's Kisunla (donanemab), which was approved by the FDA this month.

"Alzheimer's disease affects tens of millions of people worldwide, but many remain undiagnosed and are consequently unable to be identified for clinical trials or get access to emerging treatments," Alzpath President and CEO Chad Holland said in a statement. "Collaborating with Beckman Coulter to integrate our p-tau 217 antibody into a highly accurate blood-based test run on their DxI 9000 analyzers will significantly expand access to precise testing and early diagnosis for patients around the world."

"We selected Alzpath's p-tau 217 antibody following rigorous evaluation due to its high performance in detecting amyloid pathology and ability to integrate into our advanced DxI 9000 platform to support broad-based testing," Kathleen Orland, senior VP and general manager of Chemistry and Immunoassay for Beckman Coulter Diagnostics, said in a statement. "We are excited about the combination of Alzpath and Beckman Coulter innovations coming together to develop a new fully automated, high-throughput, blood-based Alzheimer's disease test for the millions of patients who suffer from dementia worldwide."

The deal follows a licensing agreement Alzpath signed in June with Roche for its p-tau 217 antibody.

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Source: Beckman Coulter Licensing Alzpath's P-tau 217 Antibody for Use in Alzheimer's Blood Tests