The new assay measures pTau217 protein to help clinicians identify amyloid pathology in patients experiencing cognitive decline.
Roche received the CE mark for its Elecsys pTau217 blood test, an assay designed to detect Alzheimer’s disease pathology. Developed in collaboration with Eli Lilly and Company, the test measures phosphorylated tau (pTau) 217 protein, which serves as an indicator of amyloid pathology.
The test is intended to rule in or rule out amyloid pathology in individuals presenting with symptoms or complaints of cognitive decline. According to the company, the assay can be used in both primary and secondary care settings using the same high and low cutoffs.
“The launch of pTau217 marks a significant step in providing a simple, blood-based tool to diagnose Alzheimer’s much earlier in the patient journey,” says Matt Sause, CEO of Roche Diagnostics, in a release. “By bringing this advanced test into routine care, we are helping physicians to support patients and families with an earlier assessment that is critical for timely intervention, while reducing pressure on healthcare systems.”
Currently, diagnosing dementia takes an average of 3.5 years, and an estimated 75% of people living with dementia remain undiagnosed, according to the release. While positron emission tomography scans and cerebrospinal fluid assessments are the current standards for confirming amyloid pathology, these methods can be expensive or difficult to access. The Elecsys pTau217 test is designed to provide a minimally invasive alternative via routine blood draw with accuracy comparable to spinal fluid diagnostics.
“For millions of families navigating the uncertainty of Alzheimer’s, a timely diagnosis is the first and most critical step toward meaningful care,” says Carole Ho, MD, executive vice president and president, Lilly Neuroscience, in a release. “Lilly’s collaboration with Roche on the Elecsys pTau217 assay was driven by a shared commitment to bringing this innovation into routine practice, overcoming complexity in testing and enabling patients to make informed decisions about the future.”
The CE mark was granted based on data from retrospective studies involving populations at the earliest stages of the disease, including those with subjective cognitive decline, mild cognitive impairment, and mild dementia. Detecting amyloid pathology early allows patients and caregivers to access appropriate care and plan for the cause of symptoms, according to the press release.
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