The FDA approval expands the use of CINtec PLUS Cytology to triage women who tested positive for cervical cancer, with high-risk types of human papillomavirus (HPV)
FDA expands approval for CINtec PLUS Cytology test. (Credit: F. Hoffmann-La Roche Ltd.)
Roche has secured the US Food and Drug Administration (FDA) approval for expanded use of CINtec PLUS Cytology, a triage test that leverages biomarker technology.
The regulatory approval expands the use of CINtec PLUS Cytology to triage the women who tested positive in cervical cancer screening, with high-risk types of human papillomavirus (HPV).
The approval also enables the laboratories to use the test to triage positive results from the cobas HPV Test run on the fully automated cobas 6800/8800 Systems.
High-risk HPV is the main cause of cervical cancer, which is most common among women, and screening of HPV DNA help identify the women at risk for cervical cancer.
Roche said that the additional information provided by the test would support the clinical decisions on determining which women would get more benefits from immediate follow-up.
Roche Diagnostics CEO Thomas Schinecker said: “With our portfolio of cervical cancer tests and automated testing platforms, we are committed to providing clinicians and laboratories with the best tools possible to protect women’s health.
“This expanded indication for CINtec PLUS Cytology gives laboratories the flexibility to triage cobas HPV test results on their choice of cobas Systems and deliver accuracy needed to reliably detect HPV infections that are starting to cause cellular changes that could lead to cancer.”
CINtec PLUS Cytology test runs on the BenchMark ULTRA IHC/ISH system
The test is designed to simultaneously detect the presence of biomarkers p16 and Ki-67, within a single cell. The test runs on the BenchMark ULTRA IHC/ISH system.
BenchMark ULTRA system is an automated immunohistochemistry and in situ hybridisation slide staining system.
The test is performed using the same sample that is used for HPV or liquid-based Pap cytology tests, preventing the need for redundant sample collection, and saves time.
The expanded FDA approval is based on data from the Roche-sponsored registrational IMproving Primary screening And Colposcopy Triage (IMPACT) clinical trial. The trial enrolled around 35,000 women in the US to evaluate CINtec PLUS Cytology as a triage test in different screening scenarios.
Prior to the expansion of FDA approval, CINtec PLUS Cytology has been used as a triage test for patients tested HPV-positive and with mildly abnormal Pap cytology, in Europe, Asia, South America, Canada and Australia.