Biomarker test to ID Alzheimer’s wins FDA breakthrough designation

Elecsys pTau217 assay measures the levels of phosphorylated tau 217

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

Share this article:

Share article via email
An illustration shows hands together in a circle giving the thumbs-up sign.

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Elecsys Phospho-Tau 217 (pTau217), a blood-based biomarker test that can help distinguish Alzheimer’s disease from other neurodegenerative disorders.

The test, developed by Roche in collaboration with Eli Lilly, is intended to support a more accurate Alzheimer’s diagnosis in adults, ages 60 and older, when used with other clinical assessments.

Breakthrough device designation is granted to medical devices that provide a more effective way of treating or diagnosing a life-threatening or irreversibly debilitating disease. The designation is meant to speed the device’s development toward regulatory approval.

If approved, the test would allow patients a more swiftly diagnosis and access to early treatment, according to Roche.

“We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease, a condition where Roche Diagnostics is committed to improving the lives of patients worldwide. We plan to leverage our installed base of diagnostic systems, which is the largest in the world, to ensure we are able to create access to this test for those who need it the most,” Matt Sause, CEO of Roche Diagnostics, said in a company press release.

Recommended Reading
gantenerumab named FDA breakthrough therapy/Alzheimer's News Today/woman with megaphone announcement illustration

FDA Grants Breakthrough Therapy Designation to Gantenerumab

A more accurate Alzheimer’s diagnosis

Diagnosing Alzheimer’s disease relies mostly on clinical symptoms, including cognitive assessments. Since symptoms can develop over several years, patients are usually diagnosed in advanced stages of the disease, however.

“The incidence of dementia is growing worldwide, with 75 percent of cases remaining undiagnosed. Consequently, there is a critical role for [Roche] to play in addressing this global health challenge,” Sause said.

In Alzheimer’s, amyloid-beta and phosphorylated tau proteins accumulate to toxic levels in the brain. This begins early on in the disease course and contributes to nerve cell death. For this reason, the proteins are considered early biomarkers of the disease.

The Elecsys pTau217 assay measures the levels of phosphorylated tau 217. A positive outcome indicates a person has a higher probability of having Alzheimer’s, which would be confirmed with a positive beta-amyloid result in a PET scan or sample of cerebrospinal fluid (CSF), which surrounds the brain and spinal cord.

“The development of the Elecsys pTau217 plasma assay is another milestone in our collaboration with Roche Diagnostics that will advance the Alzheimer’s diagnostic ecosystem,” said Anne White, executive vice president of Eli Lilly and president of Lilly Neuroscience. “We’re excited to help meet the growing need for additional diagnostic tools to enable a timely and accurate diagnosis for people with Alzheimer’s disease.”

Last year, the FDA cleared two Roche tests to measure the levels of beta-amyloid and phosphorylated tau 181, another form of phosphorylated tau, in CSF samples.