Grifols has secured EU regulatory approval to market an innovative suite of Alzheimer’s disease blood tests through its subsidiary, Arachlon Biotechnology. The two diagnostic tools, ABtest-MS and ABtest-IA, carry CE marking and are designed to help clinicians assess the risk of developing Alzheimer’s by measuring amyloid peptides in blood samples. The certification covers the European Union countries as well as Iceland, Liechtenstein, and Norway, marking a meaningful milestone in early detection and proactive disease management.
ABtest-MS uses mass spectrometry to quantify Aβ40 and Aβ42 proteins in biological samples, while ABtest-IA employs the ELISA technique for the same purpose. Currently, ABtest-MS offers plasma-based testing, and ABtest-IA supports plasma as well as cerebrospinal fluid testing, subject to regulatory permissions and inspection approvals within the European framework. The tests are positioned as a quicker, less invasive, and cost-efficient option to augment standard clinical practices, according to Grifols’ assessment.
Arachlon Biotechnology specializes in researching and developing diagnostic and treatment options for Alzheimer’s disease. The use of plasma-based tests provides clinicians with a new triage criterion that can help stratify patient risk, potentially reducing the cost of recruiting participants for clinical trials of novel therapies.
Recent studies, presented at major international conferences, indicate strong predictive capability for ABtest-MS in identifying cerebral amyloid burden at very early stages of the disease. ABtest-IA demonstrates a close association between plasma β-amyloid levels and the extent of amyloid deposition in the brain. Together, these tests support the identification of individuals at higher risk of progressing to dementia and are being integrated into research on potential treatments. A clinical trial named Ambar is in Phase III, the final stage before a therapeutic drug may reach the market.
In practice, these tests offer clinicians a minimally invasive and rapid approach to risk stratification, enabling more informed decisions about patient care, enrollment in clinical studies, and early intervention strategies. The implications extend to pharmaceutical research by potentially streamlining participant selection and reducing overall study costs, while maintaining rigorous scientific and regulatory standards. The ongoing Ambar trial underscores the industry-wide momentum toward translating biomarker insights into actionable treatment pathways for Alzheimer’s disease.
With continuous advances in biomarker technology and collaborative efforts across research centers, the ABtest family represents a notable example of how blood-based assays can complement imaging and CSF analyses in creating a more nuanced, person-centered approach to brain health.