Roche Files for FDA Approval of Elecsys BRAHMS Assay

Roche Holdings, Inc. RHHBY announced that the company has submitted the Elecsys BRAHMS PCT (procalcitonin) assay for premarket notification (510k) with the FDA.

The assay is designed to provide full automation and is a specific biomarker for bacterial infection. The solution has been developed for testing patients with severe sepsis or septic shock. Roche believes that a change in procalcitonin levels over time in accordance with other clinical assessments, will enable physicians to assess the 28-day risk of mortality for patients with severe sepsis or septic shock who have been admitted to an intensive care unit.

As per the company, sepsis leads to approximately 1.6 million hospitalizations annually in the U.S. Upon approval, the assay will provide will provide fast (18-minute) and reliable results to help clinicians to determine the necessary care for managing sepsis.

Apart from providing therapeutic products and services for diverse medical needs, Roche also focuses on innovative diagnostic solutions for the early detection and treatment of diseases. Its diagnostics segment is being driven by solid performance of the professional diagnostics unit, which was, in turn, fueled by the immunodiagnostics business.

In 2015, Roche launched 7 tests and 8 instruments, including the new cobas 6800 and cobas 8800 systems, in Molecular Diagnostics, and the Ventana HE 600 system in Tissue Diagnostics. The company plans to invest further in its diagnostics segment in 2016.

Roche currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the healthcare sector include Corcept Therapeutics CORT, Sucampo Pharmaceuticals SCMP and ArQule, Inc. ARQL. All the three stocks sport a Zacks Rank #1 (Strong Buy).

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