[Edaily Reporter Na Eun-kyung] #BioDyne announced on the 18th that a research paper evaluating the clinical efficacy of “EarlyPap,” a self-collection cervical cancer screening device, has been published in the international journal *Diagnostics*. *Diagnostics* is an SCI(E)-indexed international journal covering research in the field of medical diagnostics.

Titled “Integrated Cervical Self-Sampling for Cytology, High-Risk Human Papillomavirus, and Sexually Transmitted Infection Testing: A Prospective Study,” this paper presents the results of a study conducted by researchers at Chungbuk National University Hospital.

The research team compared and analyzed self-collected samples using EarlyPop with samples collected by medical staff from 520 women. The results confirmed a high degree of concordance in liquid-based cytology (LBC), high-risk human papillomavirus (hrHPV), and sexually transmitted infection (STI) testing.

Cervical cancer screening is typically performed by healthcare professionals collecting cervical cells. Recently, self-collection methods have garnered attention as a way to increase access to screening, and demonstrating the diagnostic accuracy of self-collected specimens is considered a key challenge for commercialization.

According to the paper, 511 participants (98.5%) successfully collected their own samples on the first attempt, and 92.1% reported preferring self-collection over collection by healthcare professionals. The test agreement rates were 95.4% for high-risk human papillomavirus (HPV), 97.0% for sexually transmitted infections (STIs), and 91.7% for liquid-based cytology. The study found that the overall combined agreement rate was 88.7%, and the Kappa coefficient—which measures agreement in test results excluding chance agreement—was 0.72. A Kappa coefficient closer to 1 indicates a higher degree of agreement.

The research team explained that they confirmed the possibility of simultaneously performing Pap smears, high-risk HPV testing, and STI testing using a single self-collected sample.

The publication of this paper is expected to support BioDyne’s ongoing efforts to expand its overseas business. BioDyne is working to comply with the European Medical Device Regulation (MDR) and enter overseas markets, and plans to utilize the clinical study results in its collaborations with overseas medical institutions and partners.

A BioDyne representative stated, “The final publication of EarlyPop-related research results in an internationally reputable academic journal is a significant achievement that objectively demonstrates the product’s clinical excellence and market potential,” adding, “We will continue to strive for global market expansion and the promotion of women’s health.”