Roche has won a monumental approval from FDA that stands to enhance its cervical cancer detection offerings. The Basel, Switzerland-based company has received a nod for its cobas Human Papillomavirus (HPV) Test as a first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid.
"Before today, laboratories did not have an FDA-approved HPV test available that could cover all of the HPV screening options supported in professional guidelines and be used with both of the primary Pap test collection media," Ann Costello, Head of Roche Tissue Diagnostics, said in a release. "With this additional approval for the cobas HPV Test, laboratories and clinicians now have an approved option that can be used for all of their HPV screening indications and sample types, so they can more easily provide the most appropriate options for their patients."
The cobas HPV Test, introduced in 2011, helps healthcare providers identify women at risk for cervical cancer by individually identifying the presence of the DNA of HPV genotypes 16 and 18—the two genotypes responsible for about 70% of all cervical cancer—and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. Roche received the first FDA approval to use an HPV test for primary cervical cancer screening (without an accompanying Pap test) for the cobas HPV Test in 2014.
The approval comes on the heels of the company making a significant acquisition. In June, Roche spent $2.4 billion to acquire the remaining shares of Foundation Medicine, a company that develops genomic profiling assays to pair cancer patients with relevant treatments and clinical trials.