|Roche is seeking another FDA approval for its Cobas HPV Test.--Courtesy of Roche|
Roche ($RHHBY) is working to make its HPV test a first-line solution for cervical cancer testing, submitting new data to the FDA in hopes of widening its market share in diagnostics.
As it stands, the Cobas HPV Test is FDA-approved to detect genotypes of the virus, used in tandem with Pap cytology as part of the cervical cancer screening process. Now, Roche is pointing to three-year registry data of more than 47,000 women showing that the test's DNA detection can detect more cervical disease than Pap alone and filing a PMA to get it approved as a stand-alone.
"Our ATHENA study validates the value of HPV DNA detection, and we are confident that these data will demonstrate to the FDA that we have established the clinical utility of the Cobas HPV Test in primary screening for physicians and their patients," Roche Molecular Diagnostics Head Paul Brown said in a statement.
If the FDA agrees and Cobas HPV becomes a primary screening test for cervical cancer, the Swiss diagnostics giant will have a chance to further capitalize on the stateside market, adding to its 20% share of the global diagnostics pie.
Last month, the FDA approved a streamlined workflow process for Cobas HPV, allowing samples to be inserted directly into Cobas 4800 analyzers, the latest in a string of regulatory and commercial wins for Roche's banner diagnostics system. In May, the company won agency approval for an EGFR mutation test on the Cobas platform, and, in March, it secured the agency's OK for a viral load hepatitis C test on the same system.
However, while Roche piles up profits from point-of-care testing, the company is switching up the rest of its diagnostics segment to ward off flattening sales. In April, Roche revealed its plans to dissolve its applied science business en masse, cutting 170 jobs around the world and discontinuing a host of research-use products. On the diabetes side, Roche is slashing about 100 positions, shuffling its test-development operation to Indianapolis while shipping insulin pump R&D to Germany.
- read the announcement