NEW YORK — Diagnostics firm Diadem said Wednesday that it has licensed exclusive US rights to its AlzoSure Predict Alzheimer's blood test to Quest Diagnostics.
Under the agreement, Quest can develop, validate, and market the assay, which is intended to identify individuals likely to progress to Alzheimer's disease, as a laboratory-developed test in the US.
AlzoSure Predict measures a variant of the p53 protein that has been linked to Alzheimer's disease. According to Milan, Italy-based Diadem, the test can help identify whether individuals will experience significant cognitive decline due to Alzheimer's up to six years prior to the onset of symptoms. The test was granted breakthrough device designation by the US Food and Drug Administration in 2022.
"We are delighted to be working with Quest, an industry leader and innovator in novel prognostic and diagnostic tests for Alzheimer's disease, to advance the development and commercialization of test options in the US based on our AlzoSure Predict technology," Diadem CEO Paul Kinnon said in a statement.
"Reliable, convenient, and affordable blood tests are essential to the identification of AD risk in early stages, when interventions hold the greatest potential to slow disease progression," Kathleen Valentine, VP and general manager of neurology at Quest. "We are encouraged by the clinical research and FDA breakthrough designation for AlzoSure and the opportunity to broaden quality and access to AD testing options supporting better patient care."
Financial and other terms of the agreement were not disclosed.