AlzoSure Predict is a non-invasive biomarker blood-based test that measures blood levels of a conformational variant of the p53 protein that has been linked to the pathophysiology of AD
Quest Diagnostics has licensed Diadem’s AlzoSure Predict prognostic test in the US. (Credit: Tatiana from Pixabay)
Diadem has signed an exclusive US licensing agreement with Quest Diagnostics for its AlzoSure Predict prognostic technology to enhance access to blood tests for assessing the risk of Alzheimer’s disease (AD).
AlzoSure Predict is said to be a rapid, accurate, and cost-effective non-invasive biomarker blood-based test. It is intended to measure blood levels of a conformational variant of the p53 protein, that has been linked to the pathophysiology of AD, by using a proprietary antibody U-p53AZ.
As per the agreement, Quest Diagnostics, which is an American diagnostic information services provider, has secured exclusive US rights to the intellectual property of AlzoSure Predict.
Quest Diagnostics will develop, validate, and sell a diagnostic service designed in a laboratory for patients and providers in the US.
The agreement’s financial details were not disclosed.
Quest Diagnostics neurology VP and general manager Kathleen Valentine said: “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.
“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.”
According to a large body of clinical data, AlzoSure Predict is useful in predicting whether people over 50 will face significant cognitive decline from Alzheimer’s disease up to six years before the appearance of symptoms.
The results confirmed the strong prognostic performance of AlzoSure Predict based on longitudinal data from 479 people aged 60-85 who took part in the Australian Imaging, Biomarkers and Lifestyle (AIBL).
AlzoSure Predict has received breakthrough device designation from the US Food & Drug Administration (FDA) and CE-IVD marking in the European Union.
Diadem CEO Paul Kinnon said: “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 commercialisation of test options in the US based on our AlzoSure Predict technology.”
“The decade of work by our researchers and collaborators to clinically validate this important technology is bearing fruit as new therapies and growing knowledge about Alzheimer’s disease are providing hope that early interventions may slow or stop disease progression.”