Roche clears FDA hurdle with Alzheimer's testing products

Roche announced on Friday that the US Food and Drug Administration (FDA) has granted ‘Breakthrough Device Designation’ to ‘Elecsys beta-Amyloid (1-42) CSF and ‘Elecsys’ Phospho-Tau (181P) CSF.

The Swiss drugmaking giant said the in vitro diagnostic immunoassays were for the measurement of the beta-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF), in adult patients with cognitive impairment who were being evaluated for Alzheimer's disease (AD) or other causes of dementia.

Currently, the diagnosis of AD was largely based on clinical symptoms, including cognitive testing, with a significant number of patients diagnosed when their disease had already advanced.

Roche said a diagnosis of AD based on cognitive measures alone was only correct in between 70% and 80% of cases.

Measuring biomarkers with CSF immunoassays, associated with AD pathology, apparently increased the certainty of a diagnosis of AD, and could help to evaluate the progression of the disease.

The Breakthrough Device Designations were for indication of use with Elecsys beta-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF in concordance with amyloid PET visual read result and risk of cognitive or functional decline.

Roche said the Breakthrough Devices Program was a voluntary program for certain medical devices that provided for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition.

The programme was designed to expedite the development and review of such medical devices.

"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 Roche Diagnostics chief executive officer Roland Diggelmann.

“Roche was one of the first companies to use biomarkers in clinical trials and we will continue to explore high-performing diagnostic and disease-monitoring solutions.”