SAN CARLOS, Calif.--(BUSINESS WIRE)--IncellDx, Inc., a global leader in single-cell diagnostics, announces approval by the Costa Rican Ministry of Health of its Next Generation HPV/cervical cancer assay, OncoTect 3Dx. This novel assay is the only test to simultaneously detect and quantify 3 molecular markers of cervical cancer—overexpression of oncogenes (E6, E7 mRNA), proliferation, and aneuploidy. Using high throughput flow cytometry, 96 cervical cytology samples can be tested and resulted in less than 4 hours, without having to examine slides.
“We are thrilled to have received approval for the HPV OncoTect 3Dx assay, thanks to the perseverance of our team and our international collaboration with IncellDx,” said Dr. Rodrigo Mora, Ph.D., Professor of Medical Virology, Faculty of Microbiology, University of Costa Rica. “We are so looking forward to start offering this test to women in Costa Rica who are currently at risk of over-treatment. Now, we will finally be able to distinguish and separate HPV infection from HPV disease to contribute to the health of our women and reduce the psychological burden associated with HPV.”
Nearly 1.9 million women are at risk of cervical cancer in Costa Rica, and it is the 3rd most common female cancer in the country. Human Papillomavirus (HPV) infection has been directly linked to the development of cervical intraepithelial lesions and increased risk for cervical cancer. The HPV OncoTect 3Dx assay aids in the determination of which patients need to be further evaluated for the presence of high-grade cervical intraepithelial neoplasia.
Dr. Bruce Patterson, chief executive officer of IncellDx, added, “We appreciate the hard work done by Dr. Mora and his team in validating this assay for staging of cervical cancer using the only test in the world that combines three molecular biomarkers in a single assay in intact cells from a liquid-based cytology specimen. This assay is the next step after determining infection with a high-risk HPV genotype to determine the biological behavior of high-risk HPV infections when the overwhelming majority of these infections will not progress to cervical cancer.”
About IncellDx, Inc.
IncellDx, Inc., located in San Carlos, California, is a molecular diagnostics company dedicated to revolutionizing healthcare, one cell at a time. By combining molecular diagnostics with high throughput cellular analysis, the company’s focus is on critical life threatening diseases in the areas of COVID-19, infectious disease and oncology, specifically cervical, head and neck, lung, bladder, breast and prostate cancers.