FDA grants breakthrough device designation to blood-based Alzheimer’s biomarker assay

Key takeaways:

• The in vitro immunoassay is being developed by Roche in partnership with Eli Lilly & Co.
• Blood-based biomarker assays aid health care providers in more rapidly identifying amyloid pathology.

The FDA has granted breakthrough device designation to a blood-based biomarker test to more quickly detect amyloid presence in individuals with suspected Alzheimer’s disease, according to the manufacturer.

In a press release, Roche said its Elecsys phospho-tau 217 assay, which is being developed in collaboration with Eli Lilly & Co., is intended to be an in vitro diagnostic immunoassay to quantitatively determine presence of the disease-specific protein taken in human plasma from individuals aged 60 years and older.

“We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease, a condition where Roche Diagnostics is committed to improving the lives of patients worldwide,” Roche Diagnostics CEO Matt Sause said in the release.

A phosphorylated fragment of the protein tau, p-tau 217 has previously demonstrated the ability in research settings to distinguish AD from other neurodegenerative disorders, along with strong performance relative to other biomarkers, per the release.

Breakthrough designation for Roche’s assay comes just over a month after the FDA granted the same status for a similar p-tau 217 biomarker assay from Quanterix.

“Blood-based tests for Alzheimer’s can be run inexpensively and at scale in large populations,” Brad Moore, president and CEO of Roche Diagnostics North America, told Healio in an email. “Roche is working to ensure worldwide access to timely Alzheimer’s diagnosis for patients and [health care providers].”