Roche Tissue Diagnostics has won U.S. Food and Drug Administration approval for a test for women with the human papillomavirus infection who are at risk of cervical cancer.
The CINtec PLUS Cytology test identifies those women whose HPV infections are most likely to be associated with cervical pre-cancers, said Roche, which has its U.S. headquarters and major development and manufacturing operations in Oro Valley.
While most HPV infections heal on their own, some women who test positive for the virus or whose co-testing results are inconclusive may develop pre-cancerous cervical lesions that, if left untreated, may progress to cervical cancer, Roche said.
About 13,800 new cases of invasive cervical cancer will be diagnosed in the U.S. in 2020, according to the American Cancer Society, and about 4,290 women will die from the disease this year, Roche noted.
Persistent infection with HPV is the principal cause of cervical cancer, with the virus implicated in more than 99 percent of cervical cancers worldwide, the company said.
The new test is expected to be widely commercially available in the U.S. later this year, Roche said.
