Roche has secured the US Food and Drug Administration (FDA) approval for its CINtec PLUS Cytology test that provides additional information for HPV-positive women at risk of developing cervical cancer.
The approval comes from data of the Roche-sponsored registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial.
CINtec PLUS Cytology is a biomarker-based triage test, claimed to provide precise information that HPV-positive women may stand to benefit the most from immediate referral to colposcopy versus repeat testing.
Persistent HPV virus infection is implicated in more than 99% of cervical cancers globally, considered to be one of the leading causes of the disease.
Most HPV infections are said to reduce on their own. However, in some women, whose co-testing results are inconclusive, HPV-positive and Pap cytology-negative, it may develop pre-cancerous cervical lesions. If left untreated, these lesions may progress to cervical cancer.
Early identification of women who are at most risk is vital for determining the treatment.
Roche Diagnostics CEO Thomas Schinecker said: “Despite being nearly 100% preventable, cervical cancer is still one of the most common cancers in women worldwide.
“To address this, Roche is dedicated to investing in next-generation biomarkers that will significantly advance screening strategies and support global efforts to eradicate this disease. We are committed to providing women with the protection and care they deserve.”
According to the American Cancer Society, around 13,800 new cases of invasive cervical cancer will be diagnosed this year in the US, and approximately 4,300 women could die from the disease.
Roche claims that its test will prevent both overtreatment and undertreatment in cervical cancer cases.
CINtec PLUS Cytology should be commercially available in the US later this year.
Last December, Roche Molecular Systems also gained marketing authorisation from the FDA for a diagnostic test to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacteria.