Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer’s disease
Roche announced it has received CE Mark for its Elecsys pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer’s disease.
The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative.
With a negative Elecsys pTau181 blood test, people can avoid further unnecessary investigations for Alzheimer’s using positron emission tomography (PET) or cerebrospinal fluid (CSF) assessment and can identify the care pathway that is right for them.
Clinical study results support that the test can be implemented effectively across care settings, including primary care, where most patients first seek help for cognitive concerns. Those with positive results are then able to undergo further testing, supporting earlier identification of Alzheimer’s pathology.
The CE Mark for the Elecsys pTau181 blood test was based on data from a prospective, multicenter study, which included 787 patients across the US, Europe and Australia. The study showed the test was able to rule out Alzheimer’s disease with a high negative predictive value (NPV) of 93.8% based on a 22.5% prevalence of amyloid positivity according to positron emission tomography (PET) scans, with 83.6% sensitivity. The rule out performance of the test was only minimally impacted by the patients’ age, gender, body mass index or impaired kidney function.
This global, prospectively collected, diagnostic registrational clinical study was the first of its kind in the industry to investigate the test’s clinical performance in a diverse patient population, aged 55-80 years old that reflects as closely as possible the patients who could benefit from the test. It involved a subset of patients from a wider study looking at a highly diverse set of patients with broad inclusion criteria, to ensure the test could be used effectively across different geographies and ethnicities.
Roche is also developing the Elecsys pTau217 blood test, an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) in human plasma for use as an aid in identifying amyloid pathology.
