The trial data shows clear benefit in using Roche's CINtec PLUS Cytology test for women who are at higher risk of developing cervical cancer
Roche Diagnostics administration and R&D buildings. (Credit: F. Hoffmann-La Roche Ltd.)
Roche’s CINtec PLUS Cytology dual-stain biomarker technology showed positive outcomes as a triage test for women with high-risk human papillomavirus (HPV) in IMPACT trial.
IMPACT is an observational cervical cancer screening study that enrolled around 35,000 women aged 25 to 65 years, at 32 clinical sites in 16 states across the US.
It was designed to validate the clinical utility of cobas HPV testing for primary screening in combination with CINtec PLUS Cytology as a follow-up test for patients with positive screening results, said Roche.
The CINtec PLUS Cytology test runs on the BenchMark ULTRA IHC/ISH system and is performed using the same sample as HPV or liquid-based Pap cytology tests.
In the study, women with high-risk HPV received a follow-up triage test to determine if their cervical cells were transforming to cervical pre-cancer.
Triaging with CINtec PLUS Cytology showed a superior sensitivity in detecting cervical pre-cancers compared to Pap cytology, said the company.
Roche Diagnostics CEO Thomas Schinecker said: “Roche is committed to investing in and leading efforts such as the IMPACT trial to bring forth clinically validated solutions for women.
“The elimination of cervical cancer is within reach, and all countries must act now so that women, no matter where in the world they live, no longer die from this preventable disease.
“Our investment in HPV primary screening and next-generation biomarker technology gives clinicians even more powerful tools in the fight against cervical cancer.”
Women who test positive for the HPV may develop pre-cancerous cervical lesions that, if left untreated, may progress to cervical cancer.
According to the company, cervical screening offers a way to identify women at risk for disease before the invasive cancer develops.
Its CINtec PLUS Cytology may significantly improve the detection of cervical disease when women are screened for cervical cancer.
Also, it helps clinicians in determining women who are at high risk for cervical pre-cancer and require immediate diagnostic procedures, and women who may need repeat testing.
In September last year, the US Food and Drug Administration (FDA) has approved the expanded use of CINtec PLUS Cytology, to triage women who tested positive for cervical cancer.