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

The FDA has granted breakthrough device designation to a phospho-tau 217 blood-based biomarker to assist in the diagnosis of Alzheimer’s disease, according to the manufacturer.

In a company press release, Quanterix Corp. said the Simoa assay is a semi-quantitative in vitro diagnostic immunoassay intended to measure p-tau 217 concentration in plasma using the Quanterix HD-X immunoassay system.

The assay may be a valuable diagnostic tool for individuals presenting to a clinical setting with cognitive impairment who are also being evaluated for AD risk. The test is not intended as a standalone diagnostic; test results are meant to be interpreted in conjunction with other diagnostic tools to establish an accurate diagnosis, the company said.

Blood-based biomarkers offer the potential for a rapid, noninvasive diagnostic method in contrast to traditional methods of positron emission tomography or lumbar puncture for cerebrospinal fluid.

Breakthrough designation is typically granted to products with potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need; however, it does not guarantee that the subsequent FDA review and approval process will be shortened or an application will be approved.

“New resources available to aid in diagnosis and treatment of Alzheimer’s disease have contributed to a more optimistic environment for patient care,” Kirk Erickson, PhD, director of translational neuroscience at the AdventHealth Neuroscience Institute, told Healio. “The availability of blood-based biomarker testing to the AdventHealth network has the potential to help a wide population concerned about mild cognitive impairment and aid physicians in their diagnosis.”