Roche Diagnostics Takes Initiative to Raise Awareness on the Importance of Early Detection of Cervical Cancer

Korea Roche Diagnostics announced that it successfully held the ‘CINtec PLUS Symposium’ for the early diagnosis of cervical cancer on the 24th. The symposium was conducted for obstetrics and gynecology pathology medical staff to introduce the CINtec PLUS test and provide education on its interpretation. Professor Yoo Jong-woo from the Department of Pathology at the National Cancer Center served as the chairperson.

[Photo by Korea Roche Diagnostics]

The CINtec PLUS test is an immunocytochemical assay that evaluates the risk of cervical cancer through dual staining of the p16 and Ki-67 biomarkers. p16 is expressed when the tumor suppressor function is impaired during the carcinogenesis process within cells. Ki-67 is a protein indicating cell proliferation, and when co-expressed with p16, it suggests precancerous or cancerous changes. This allows for the detection of precancerous changes in cervical cancer regardless of human papillomavirus (HPV) infection status, which is commonly known as a cause of cervical cancer, thereby supporting more precise diagnosis and treatment decisions for HPV-positive patients.

The symposium covered patient cases applicable for the CINtec PLUS test, reflecting the 2024 American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines. The applicable cases included ▲ patients with cervical cytology results showing atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL), ▲ patients testing HPV positive in HPV DNA testing, and ▲ patients who underwent both cervical cytology and HPV DNA testing simultaneously, where cytology results were normal but HPV DNA testing was positive, showing discordant results.

Last month, the World Health Organization (WHO) included Roche Diagnostics’ CINtec PLUS test in its cervical cancer prevention recommendations for accurate risk stratification and treatment of HPV-positive screened patients. This WHO recommendation highlights the clinical significance of the CINtec PLUS test and is expected to play a crucial role in the early detection and prevention of cervical cancer.

HPV DNA testing, one of the main methods for cervical cancer screening, detects HPV infection, most of which naturally clears within 1 to 2 years. However, in cases with high-risk HPV positive results, the use of the CINtec PLUS test allows for the confirmation of persistent HPV infection and the presence of precancerous cells, enabling a more accurate assessment of the potential progression to cervical cancer.

Kit Tang, CEO of Korea Roche Diagnostics, stated, “The ability to detect cervical cancer early through innovative diagnostic solutions like the CINtec PLUS test is a significant advancement that can provide better treatment outcomes for patients.” He added, “Korea Roche Diagnostics will continue to support the diagnosis of various diseases, including cervical cancer, based on innovative technologies and strive to improve patients’ quality of life.”

Professor Yoo Jong-woo, who chaired the symposium, also commented, “The CINtec PLUS test is an important tool that goes beyond HPV infection status to deeply assess the potential risk of cervical cancer.” He evaluated, “It will play a key role in enhancing the accuracy and utility of cytopathology tests and in the early diagnosis and prevention of cervical cancer.”