FDA approval of CINtec PLUS Cytology as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for HPV using the cobas® 4800 HPV Test.- Roche

Roche announced the 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. 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. The 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 US to clinically validate CINtec PLUS Cytology as a triage test in different screening scenarios. Publication of study data is pending. CINtec PLUS Cytology is expected to be widely commercially available in the US later in 2020. About the CINtec PLUS Cytology test- The Roche cobas 4800 HPV Test, used in combination with CINtec PLUS Cytology and CINtec Histology, offers clinicians and labs in the US powerful support they have not had before. The dual-stain biomarker technology included in the CINtec PLUS Cytology test detects the simultaneous presence within a single cell of the two biomarkers -- p16 and Ki-67. This abnormality is associated with HPV infections that are transforming and can, if left untreated, progress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease. The ability of CINtec PLUS Cytology to distinguish those women who are at higher risk for cervical disease provides labs, clinicians and women, in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines information, to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money. 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 US, the CINtec PLUS Cytology test, which runs on the BenchMark ULTRA IHC/ISH system, had been used as a triage test for HPV-positive results and mildly abnormal Pap cytology results in Europe, Asia, South America and Australia.