Sam Brusco, Associate Editor01.18.22
Diadem U.S. has earned breakthrough designation from the U.S. Food and Drug Administration (FDA) for its AlzoSure Predict blood-based biomarker prognostic assay, which identifies whether people over 50 with cognitive impairment symptoms will or won’t progress to Alzheimer’s disease up to six years before definitive symptoms become apparent.
The company’s application was supported by a 482-patient study showing AlzoSure can identify whether people will progress to fully fledged Alzheimer’s up to six years before the illness is apparent. Subjects were 50 year or older any asymptomatic or at the easly stages of Alzheimer’s or other dementias. The study’s second phase is due to be complete in the coming months—it will include biobank data on over 1,000 additional U.S. and European patients.
"Obtaining this FDA Breakthrough Device designation reinforces our view that AlzoSure Predict is a potential game changer for the early identification and management of Alzheimer's disease, which afflicts millions of patients and their families worldwide," Paul Kinnon, Diadem’s CEO told the press. "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."
AlzoSure Predict is a simple, non-invasive plasma-based biomarker test. The firm’s technology uses an analytical method with a proprietary, patented antibody that binds to U-p53AZ and its target sequences. U-p53AZ is a conformational variant of the p53 protein implicated in the pathogenesis of Alzheimer’s in multiple studies.
The company’s application was supported by a 482-patient study showing AlzoSure can identify whether people will progress to fully fledged Alzheimer’s up to six years before the illness is apparent. Subjects were 50 year or older any asymptomatic or at the easly stages of Alzheimer’s or other dementias. The study’s second phase is due to be complete in the coming months—it will include biobank data on over 1,000 additional U.S. and European patients.
"Obtaining this FDA Breakthrough Device designation reinforces our view that AlzoSure Predict is a potential game changer for the early identification and management of Alzheimer's disease, which afflicts millions of patients and their families worldwide," Paul Kinnon, Diadem’s CEO told the press. "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."
AlzoSure Predict is a simple, non-invasive plasma-based biomarker test. The firm’s technology uses an analytical method with a proprietary, patented antibody that binds to U-p53AZ and its target sequences. U-p53AZ is a conformational variant of the p53 protein implicated in the pathogenesis of Alzheimer’s in multiple studies.