Exciting News: HPV Genotyping Real-Time PCR Kit Achieves CE-IVDR Registration

Bioer Technology is pleased to announce that its HPV Genotyping Real-Time PCR Kit (Fluorescent PCR) has successfully obtained CE-IVDR registration, marking another important milestone in our commitment to advancing molecular diagnostics and supporting global cervical cancer prevention.

Addressing a Growing Global Need for HPV Testing

Human papillomavirus (HPV) is one of the most common sexually transmitted infections worldwide. Persistent infection with high-risk HPV types is the primary cause of cervical cancer, with almost all cervical cancer cases linked to high-risk HPV infection. According to the World Health Organization (WHO), cervical cancer remains a major global public health challenge, with approximately 604,000 new cases and 280,000 deaths reported in 2024.

At the same time, cervical cancer is highly preventable through vaccination, screening, early detection, and timely treatment. As countries accelerate implementation of cervical cancer elimination strategies, the demand for reliable, high-performance HPV molecular testing continues to grow.

Importantly, HPV testing is evolving beyond simple positive/negative detection. In its 2026 guideline, WHO highlights the role of HPV DNA genotyping in risk stratification and molecular triage, enabling screening programmes to better identify women at higher risk and prioritize appropriate follow-up and clinical management.

This shift toward genotype-specific information is creating new opportunities for molecular diagnostic technologies that can combine broad HPV coverage, reliable performance, workflow efficiency, and actionable genotyping information.

Introducing the HPV Genotyping Real-Time PCR Kit

The HPV Genotyping Real-Time PCR Kit (Fluorescent PCR) is a qualitative in vitro diagnostic assay designed for the detection of HPV nucleic acids in cervical specimens collected by healthcare professionals.

The assay provides differentiated detection of 17 HPV genotypes, including HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, and 68. In addition, HPV genotypes 26, 73, and 82 are detected collectively, providing broader coverage of clinically relevant HPV infections.

The assay is designed to support laboratories seeking a practical and comprehensive molecular approach to HPV detection and genotyping.

Key Product Advantages

Broad Genotype Coverage

The assay covers multiple clinically relevant HPV genotypes, including the high-risk types HPV 16 and HPV 18, as well as other oncogenic and low-risk types, supporting more comprehensive HPV testing.

Reliable Diagnostic Performance

Clinical performance was evaluated using 908 clinical specimens across four independent clinical sites, demonstrating:

Diagnostic Sensitivity: 99.84% (99.11%–99.97%)

Diagnostic Specificity: 99.27% (97.39%–99.80%)

Diagnostic Accuracy: 99.67% (99.03%–99.89%)

With the CE-IVDR registration of the HPV Genotyping Real-Time PCR Kit, Bioer Technology is strengthening its ability to support this global shift toward molecular HPV screening and precision-oriented cervical cancer prevention.

This is more than a regulatory milestone. It is another step in our journey to make high-quality molecular diagnostics more accessible to laboratories and healthcare systems worldwide.