Biomarker Tests for Alzheimer's Disease Gain FDA Breakthrough Designation

JULY 20, 2018
Cecilia Pessoa Gingerich
FDA, SYMTUZA, HIVThe US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Roche’s Elecsys beta-Amyloid (1-42) and Elecsys Phospho-Tau (181P) cerebrospinal fluid assays.

The diagnostic immunoassays measure the beta-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of dementia. The assays are intended to help diagnose Alzheimer’s disease by using the biomarkers instead of relying on clinical symptoms alone.

The Elecsys cerebrospinal fluid immunoassays can help clinicians detect Alzheimer’s disease at an earlier stage, alerting clinicians and patients. There are currently no cures for Alzheimer’s disease, but a variety of treatments directed at alleviating symptoms of the disease.

Research done by Shana Stites, PsyD, Perelman School of Medicine, University of Pennsylvania, highlighted the potential pitfalls of biomarker-based information about Alzheimer’s disease, due to the stigma still common regarding the disease.

"The Genetic Information Nondiscrimination Act of 2008 (GINA) helps to protect against discrimination on the basis of genetic data so this may offer assurance and protection to those who learn their genetic risk of Alzheimer's," Stites told MD Magazine® previously. "But currently there are no policies to offer similar protections for individuals on the basis of a biomarker result.”

The Elecsys beta-Amyloid (1-42) CSF, Elecsys Phospho-Tau (181p) CSF, and Elecsys(R) Total-Tau CSF immunoassays are currently approved in countries accepting the CE Mark. Voluntary participation in the Breakthrough Device Program will help expedite the development and FDA review of the CSF assays.

"We are excited about FDA's recognition of the potential clinical benefit the Elecsys CSF assays can bring to clinicians, laboratories, and their patients in diagnosing AD at an early stage," said Roland Diggelmann, CEO of Roche Diagnostics, in a statement.

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