China FDA approves Roche's cervical test CINtec

The China FDA has approved cervical disease test CINtec PLUS Cytology from Basel-based Roche ($RHBBY), bolstering the company's offerings in China where nearly 62,000 new cases of cervical cancer are reported annually.

Roland Diggelmann, COO of Roche Diagnostics

Roche said in a release the test is designed to improve detection and provide the opportunity for early intervention of precancerous cervical disease.

Approval followed a multicenter study of the device at five participating hospitals throughout China for patients at higher risk of developing cervical cancer when compared to conventional screening methods like Pap cytology.

Screening for the human papillomavirus (HPV) in China is considered a public health priority in studies cited in Nature and elsewhere as other treatments and prevention therapies lag.

Vaccines from Merck ($MRK), Gardasil/Gardasil 9, and GlaxoSmithKline ($GSK), Cervarix, are available in many parts of Asia, but not Mainland China though Hong Kong and Macau provide access through physicians.

Roche said that the CINtec PLUS Cytology test was developed to detect "two biomarkers associated with persistent HPV infections that may lead to cancer, distinguishing them from those that are likely to resolve on their own."

Roche noted the CINtec p16 Histology test "helps pathologists confirm the presence or absence of cervical pre-cancers in biopsies obtained during colposcopy."

The test is part of a broader offering in cervical screening that includes the cobas test, aimed at the highest-risk genotypes, HPV 16 and HPV 18, which was approved by the U.S. FDA in April of 2014 for primary screening of cervical cancer.

- here's the release