Roche CINtec PLUS Cytology Test Approved by CFDA for Cervical Cancer Prevention

On March 9, 2016, Roche announced that the China Food and Drug Administration (CFDA) approved the CINtec PLUS cytology test to improve the detection and early intervention of cervical precancerous lesions.

A multicenter study conducted by five hospitals in China showed that CINtec PLUS cytology tests determine which women have a higher risk of developing cervical cancer than traditional screening methods (such as Pap smear cytology). Overall performance is better, sensitivity and specificity are higher. This is consistent with previously published data and provides a basis for the CFDA to approve the test.

Almost all cervical cancers are caused by human papillomavirus (HPV) infection, but only women who have sustained HPV infection and have developed high-grade cervical precancerous lesions should take treatment. CINtec PLUS cytology is used to detect two biomarkers that may cause cancer after persistent HPV infection, distinguishing them from infections that may heal themselves.

There are about 62,000 new cases of cervical cancer in China every year, and about 30,000 women die of cervical cancer each year.

“By introducing the fully automated CINtec PLUS cytology test, we provide the most comprehensive cervical cancer screening product line for Chinese women, thus fulfilling our commitment to helping women prevent cervical cancer,” said Huang Baixing, general manager of Roche Diagnostics Greater China. “CINtec PLUS cytology testing can help reduce overdiagnosis and increase the detection rate of cervical precancerous lesions for early intervention.”

“CINtec PLUS cytology is a powerful technology for combating cervical disease and an important part of Roche's product line for the diagnosis and prevention of cervical diseases,” said Ann Costello, head of diagnosis and diagnosis of Roche Diagnostics. “It is well known that HPV is a cancer of the cervix. The cause is completely preventable. The clinically validated Roche Diagnostic Cervical Cancer Series - cobas HPV for screening, CINtec PLUS cytology for risk stratification and diagnosis, and CINtec histology - CFDA approved , greatly improving our ability to reduce the burden of the disease on a global scale."

Currently, the product is available in China, Europe, Asia, Latin America and Canada, and fully automated CINtec PLUS cytology can be performed using Roche Diagnostics with more than 10,000 installed diagnostic instruments worldwide.