The CINtec PLUS Cytology is an advanced cytology test that leverages biomarker technology and runs on the BenchMark ULTRA IHC/ISH system
Roche gets expanded FDA approval for CINtec PLUS Cytology test. (Credit: F. Hoffmann-La Roche Ltd.)
Roche has received an expanded the US Food and Drug Administration (FDA) approval for CINtec PLUS Cytology, a triage test that leverages biomarker technology.
The CINtec PLUS Cytology is an advanced biomarker cytology test that works on the BenchMark ULTRA IHC/ISH system and is performed using a similar sample used for HPV or liquid-based Pap cytology tests.
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). High-risk HPV is the primary cause of cervical cancer, which is most common among women.
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.
Roche said that the additional information provided by the test would support the clinical decisions on determining which women would get more relief 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.
“The biomarker information helps to clarify a woman’s risk of disease, reduce the potential for over- or under-treatment, and is a major step forward in individualising a woman’s care.”
CINtec PLUS Cytology is designed to detect the presence of p16 and Ki-67 biomarkers
The test is designed to simultaneously detect the presence of two biomarkers, including p16 and Ki-67, within a single cell. Screening of HPV DNA would identify the women at risk for cervical cancer.
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, the test has been used to triage HPV-positive patients and those with mildly abnormal Pap cytology, in Europe, Asia, South America, Canada and Australia.
The approval enabled laboratories to access the company’s complete Cervical Cancer Portfolio offering in the US, including the cobas HPV Test, CINtec PLUS Cytology and CINtec Histology.
Also, the labs can fully automate the high volume of assays and leverage biomarker technology to offer more advanced cytology solutions, said the company.