Roche Diagnostics scores another FDA victory

Roche won another FDA approval for its Cobas 4800 diagnostics platform.--Courtesy of Roche

With the FDA's blessing, Roche Diagnostics ($RHHBY) is the first test maker cleared to let clinicians load samples straight from vials onto the company's genotyping analyzer to screen for HPV, allowing Roche to grow its already mighty presence in the U.S. diagnostics market.

Now, samples gathered through Roche's ThinPrep Pap can be inserted directly into the company's Cobas 4800 system, testing for high-risk HPV faster and more efficiently, the company said. Roche has already soared to snag about 20% of the global diagnostics market, and this latest regulatory win will allow it to expand further in the U.S., according to the company.

"With new clinical guidelines for cervical cancer screening issued last year, the demand for HPV co-testing has the potential to increase significantly," Roche Diagnostics CMO Alan Wright said in a statement. "Giving labs the option to use the same primary vial from a Pap test for HPV testing lets them eliminate a complete step in their workflow process and lower the risk of errors in sample handling, helping to ensure that patients receive accurate test results."

Roche's has thus far ridden its Cobas analyzers and their attendant assays to continued success. In May, the company won FDA approval for an EGFR mutation test, and, in March, it secured the agency's OK for a viral load hepatitis C test on the same platform.

But while clinical tests have lined the Swiss company's pockets, Roche Diagnostics is still shuffling the rest of its operations to get revenue in line. In April, Roche unveiled plans to dissolve its applied science business, cutting 170 jobs around the world and discontinuing a host of research-use products. In the fall, Roche announced it would cut about 100 jobs from its shaky diabetes diagnostics business, putting its test-development operation in Indianapolis while shipping insulin pump R&D to Germany.

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