Roche's Next-Generation HPV Test CINtec® PLUS Approved by FDA as First Biomarker-Based Triage Assay for Cervical Cancer Screening

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When classifying HPV-positive screening results, it is more sensitive than Pap cytology testing. The FDA has approved the first biomarker-based test for further triage of HPV-positive/Pap-negative results, improving cervical cancer prevention in women.

On March 11, Roche announced that the U.S. FDA had approved its next-generation cytology test, CINtec^®PLUS, as the first biomarker-based classification assay, is used via cobas^®4800 HPV Test for Primary Cervical Cancer Screening in Women Positive for Human Papillomavirus (HPV)

The cobas 4800 HPV Test System is Roche’s current testing product for early cervical cancer prevention and screening, providing screening results for HPV types 16, 18, and 12 other high-risk subtypes. Clinical practice employs the cobas 4800 HPV DNA test for initial screening, followed by the use of CINtec^®PLUS Cytology Testing for Further Classification to Detect Malignant Transformation in Women with HPV Infection

Roche states that the CINtec PLUS Cytology Test can identify women with HPV infections most likely associated with cervical cancer. It enables clinicians to more confidently determine which women should be immediately referred for colposcopy or other diagnostic procedures to maximize benefit, thereby helping to prevent the progression to more severe cervical disease. This biomarker technology simplifies clinical decision-making by providing easy-to-understand results, allowing both clinicians and patients to clearly ascertain the next steps. This represents a significant step toward personalized care for women, preventing both overtreatment and undertreatment.

Thomas Schinecker, CEO of Roche Diagnostics, stated, “Although cervical cancer is nearly 100% preventable, it remains one of the most common cancers among women worldwide. To address this issue, Roche is committed to investing in next-generation biomarkers that will significantly enhance screening strategies and support global efforts to eradicate this disease.”

Although most HPV infections can be cleared by the immune system, some women who test positive for HPV or have indeterminate co-testing results (e.g., HPV-positive but with negative Pap cytology) may develop precancerous cervical lesions. Without timely treatment, these lesions may progress to cervical cancer; therefore, early identification of women at highest risk is crucial. According to data from the American Cancer Society, there were approximately 13,800 new cases of invasive cervical cancer in the United States in 2020, and about 4,290 women died from the disease. Persistent HPV infection is the primary cause of cervical cancer, with the virus being associated with more than 99% of cervical cancer cases worldwide.

CINtec PLUS Cytology Test incorporates dual-stain biomarker technology to detect the simultaneous presence of the biomarkers p16 and Ki-67 within individual cells. This abnormality is associated with the malignant transformation of HPV infections, which may progress to precancerous lesions or cancer if left untreated. A positive result for both biomarkers in a single cell indicates an elevated risk of cervical cancer in women. The test’s ability to identify women at high risk for cervical cancer provides laboratories and clinicians with valuable information for assessment, integrating screening history, other risk factors, and professional guidelines, while simultaneously reducing the number and frequency of follow-up outpatient visits, thereby saving time and costs. Furthermore, CINtec PLUS can be performed using the same liquid-based sample collected for HPV or Pap cytology testing. This eliminates the need for additional or repeat sample collection and avoids the wait time associated with clearing the infection.

With this approval, the FDA considered data from Roche’s pivotal IMPACT trial (Improving Management of Patients with Abnormal Cervical Cytology through Triage), which enrolled more than 35,000 women in the United States to validate the performance of the CINtec PLUS Cytology Test as a clinical triage test across various screening scenarios. Detailed study results are forthcoming. Roche expects to launch broad commercialization in the United States later in 2020.

Prior to FDA approval, the CINtec PLUS Cytology Test was used in Europe, Asia, South America, Africa, and other regions as a triage test for HPV-positive results and mild abnormalities in Pap cytology.

As early as March 2016, the former China Food and Drug Administration (CFDA) approved the market launch of Roche’s CINtec PLUS Cytology Test to improve the detection and early intervention of cervical precancerous lesions. The approval was based on a multicenter study involving five hospitals in China. Data showed that, compared with traditional Pap smear screening, the CINtec PLUS Cytology Test demonstrated a balanced performance in both sensitivity and specificity while better identifying women at higher risk of developing cervical cancer.

Reference Source: FDA Approves Roche HPV Test Add-On for Identifying Women with Higher Risk of Cervical Cancer

Original Title:Roche’s Next-Generation HPV Test Approved for Market Launch, Marking the First Biomarker-Based Classification Assay!