Blood Test of Alzheimer’s Risk in Mild Dementia Patients OK’d in Europe
A biomarker blood test called AlzoSure Predict that can help to identify people with mild cognitive impairment who are likely progress to Alzheimer’s disease — years before symptoms are evident — has been approved for use in the European Union (EU) and the U.K., its marketer, Diadem, announced.
“This first regulatory approval for AlzoSure Predict … represents a significant advance for the millions of patients and their families in Europe at risk from Alzheimer’s disease,” Paul Kinnon, CEO of Diadem, said in a press release.
The test received the European Conformity In-Vitro Diagnostic Medical Devices (CE IVD) certification, a requirement for marketing medical devices in the EU. It also enables market development across other countries.
AlzoSure Predict is rapid and non-invasive blood test designed to predict the likelihood of Alzheimer’s progression in people ages 50 or older with signs of cognitive impairment.
Diadem reported that its test can predict risk up to six years in advance of evident Alzheimer’s symptoms. The test’s accreditation was supported by the results of a retrospective study in 482 individuals taking part in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study. Launched in Australia in 2006, AIBL aims to unveil predictors — including biomarkers, cognition and lifestyle factors — of Alzheimer’s risk.
All adults who entered the study with either asymptomatic or diagnosed with early stage Alzheimer’s or mild cognitive impairment.
Results, reported by researchers that included Diadem scientists, showed that the biomarker test outperformed standard positron imaging tomography (PET) of the amyloid-beta protein in distinguishing asymptomatic and mild cognitive impaired adults from those with Alzheimer’s. Toxic aggregates of amyloid-beta are found in the brains of Alzheimer’s patients and these clumps are thought to be involved in disease onset.
A second phase of this study will include biobank data from some 1,000 additional patients in Europe and the U.S, and it should be complete in the coming months, Diadem stated in the release.
The test requires a small amount of blood — one milliliter (ml) — and uses Diadem’s proprietary and patented antibody to detect, by mass spectrometry, a specific protein, called the U-p53AZ protein. Mass spectrometry can identify and quantify proteins based on their mass-to-charge ratio, and is shown to have high sensitivity and accuracy.
U-p53AZ is the misfolded conformational variant of the p53 protein, which has been associated with prodromal and clinical progression into full-blown Alzheimer’s disease.
Diadem reports that test results of Alzheimer’s risk are available in three to four days. This will allow clinicians to better advise patients on the likely course of disease progression.
The U.S. Food and Drug Administration designated AlzoSure a breakthrough device in January. This status is given to support the development of medical technologies that may provide more effective treatment or diagnosis for life-threatening or debilitating diseases or conditions.