Roche Holdings AG (OTCQX:RHHBY) on Tuesday said it received European CE Mark approval for Elecsys pTau217, a blood test designed to help detect amyloid pathology linked to Alzheimer's disease earlier in patients showing signs of cognitive decline.
Roche Wins CE Mark For Alzheimer's Blood Test
Eli Lilly and Co. (NYSE:LLY) collaborated with Roche to develop the test to measure phosphorylated Tau 217 protein, or pTau217, a biomarker associated with Alzheimer's pathology.
Roche said the same high and low cutoff values can be applied across both primary and secondary care settings to help clinicians rule in or rule out amyloid pathology in patients reporting memory or cognitive concerns.
Roche And Lilly Highlight Need For Earlier Diagnosis
According to Roche, early identification of amyloid pathology can help patients, families, and caregivers better understand symptoms and access appropriate care sooner.
"Today, many people face a long and difficult path to a diagnosis," said Matt Sause, CEO of Roche Diagnostics. He added that the blood-based test could help bring Alzheimer's assessment into routine care while reducing reliance on specialized procedures.
Carole Ho, executive vice president and president of Lilly Neuroscience, said timely diagnosis remains critical for families navigating Alzheimer's disease.
Blood Test Could Reduce Reliance On Invasive Procedures
Roche cited global challenges in Alzheimer's diagnosis, noting that many dementia patients remain undiagnosed and often wait years after symptoms first appear before receiving a diagnosis.
The company said current approaches, such as PET scans and cerebrospinal fluid assessments, can be expensive, difficult to access, and more invasive than blood testing.
A positive Elecsys pTau217 result indicates a high likelihood of amyloid pathology, while a negative result suggests a low likelihood, potentially helping physicians avoid additional invasive testing.
Indeterminate findings would still require further assessment.
Roche Eyes Broader Rollout Following CE Mark
The CE Mark approval was supported by retrospective studies involving patients in the earliest stages of Alzheimer's disease, including subjective cognitive decline, mild cognitive impairment, and mild dementia.
Roche said the assay is compatible with its installed instrument base and supports automated, high-throughput laboratory workflows.
Following the approval, the company plans to expand availability across countries, recognizing the CE mark. Roche also said the test could potentially expand into the U.S. market pending FDA approval later this year.
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Price Action
Eli Lilly is currently trading at about $976 per share on Tuesday, according to Benzinga Pro. Over the past month, LLY has gained about 2.8% versus a 9.1% rise in the S&P 500 and is down roughly 10% year-to-date compared to the index’s 7.8% gain.
Image: Shutterstock
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