Roche receives FDA approval for cytology test to help improve cervical cancer prevention

March 24, 2020

Roche announced U.S. Food and Drug Administration (FDA) approval of CINtec PLUS Cytology as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas 4800 HPV Test. This biomarker technology simplifies clinical decision-making by providing easy-to-understand results so that clinicians and women are clear on next steps.

The CINtec PLUS Cytology test identifies those women whose HPV infections are most likely to be associated with cervical pre-cancers. It enables clinicians to more confidently determine which women should be referred to immediate further diagnostic procedures, helping to prevent women from developing more advanced cervical disease.

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. Persistent infection with HPV is the principal cause of cervical cancer, with the virus implicated in more than 99 percent of cervical cancers worldwide.

CINtec PLUS Cytology provides definitive information about which HPV-positive women may benefit most from immediate referral to colposcopy versus repeat testing. This is a major step forward to individualize a woman’s care and prevent both overtreatment and undertreatment.

FDA considered data from the Roche-sponsored registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which enrolled more than 35,000 women in the U.S. to clinically validate CINtec PLUS Cytology as a triage test in different screening scenarios. The CINtec PLUS Cytology test is expected to be widely commercially available in the U.S. later in 2020.

The new test can be performed using the same liquid sample that is used for HPV or Pap cytology testing. This eliminates the need for additional or repeat sample collection or time spent waiting to find out if an infection is clearing. Primary screening by the cobas 4800 HPV DNA test with triage using the CINtec PLUS Cytology test demonstrated the high sensitivity and specificity to detect transforming HPV infections reliably and cost-effectively.

Prior to FDA approval for use in the U.S., the CINtec PLUS Cytology test, which runs on the BenchMark ULTRA IHC/ISH system, was used as a triage test for HPV-positive results and mildly abnormal Pap cytology results in Europe, Asia, South America and Australia.

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