Roche Receives CE Mark for Elecsys® pTau217 Blood Test for Alzheimer’s Diagnosis

Elecsys® pTau217 is a new diagnostic blood test that has been CE marked by global health care company Roche and is now available in the entire European Union to help detect the pathological process of Alzheimer's disease based on a blood draw. Developed in collaboration with Eli Lilly and Company and utilises a biomarker for Alzheimer's disease and amyloid pathology called phosphorylated Tau (pTau) 217. The blood test Elecsys® pTau217 is the first to be used in Algeria to be used in both primary and secondary care, and the newest Alzheimer's blood test available for use in primary care.

Advancing Early Alzheimer’s Detection

The CE Marking will be expected to give Roche further confidence in being able to launch early diagnostics solutions for the growing Alzheimer's Disease Diagnostics Market. Getting diagnosed early provides patients and their families with earlier treatment options and starts to make informed healthcare choices.

The launch of pTau217 in routine care is helping to get the diagnosis earlier in the patient journey for those with Alzheimer's, and it will make a positive difference to the family with simplicity, said Matt Sause, CEGO at Roche Diagnostics. This will also help to relieve the strain on health systems.”

Carole Ho, Lilly’s Executive Vice President and President of Lilly Neuroscience, added, “Lilly was working on the Elecsys pTau217 assay, in parallel with Roche; we were both passionate about developing this innovation to become a routine practice that can empower patients to decide on their future treatment.”

According to Precedence Research, the Alzheimer’s Disease Diagnostics Market size was calculated at USD 9.40 billion in 2025 and is predicted to increase from USD 10.42 billion in 2026 to approximately USD 26.21 billion by 2035, expanding at a CAGR of 10.80% from 2026 to 2035, driven by increasing prevalence of Alzheimer's disease, improvement in biomarker testing, and blood-based diagnosis technologies.

Industry Impact and Outlook

Roche is working on a larger portfolio of candidate products to treat Alzheimer's disease, which spans investigational therapeutics, including trontinemab and nivegacetor, and numerous biomarker assays and digital diagnostic solutions. Roche's own approach to testing developed in the lab could open the door to the broad adoption of testing, leveraging the company's large portfolio of multiplex diagnostic instruments for patients within healthcare systems across the globe.