FDA gives breakthrough designation to blood-based test for early prediction of Alzheimer’s

The FDA has granted breakthrough device designation to Diadem U.S. Inc. for AlzoSure Predict, its blood-based test for early prediction of Alzheimer’s disease.

The company’s blood-based biomarker prognostic assay is intended to determine with high accuracy whether people older than 50 years with signs of cognitive impairment may or may not progress to AD up to 6 years before the appearance of definitive symptoms.

Diadem supported its application to the FDA on positive data from a longitudinal study with 482 participants in this patient population. The study’s second phase includes biobank data from more than 1,000 additional participants from the U.S. and Europe and is set for completion in the coming months, according to a company release.

“Obtaining this FDA breakthrough device designation reinforces our view that AlzoSure Predict is a potential game changer for the early identification and management of [AD], which afflicts millions of patients and their families worldwide,” Paul Kinnon, CEO of Diadem, said in the release. “We see the breakthrough device designation as an important step in supporting the future commercialization of AlzoSure Predict in the U.S and globally, and we look forward to working closely with the FDA to complete our clinical studies and expedite the regulatory review process.”