[Edaily Reporter NA EUN-KYUNG ] Earlypap®, a self-collection brush for cervical cancer screening developed by BIODYNE CO., LTD.(314930), has passed the European Medical Device Regulation (MDR) conformity assessment, bringing the company one step closer to commercialization overseas.

With only administrative procedures for certificate issuance remaining, the company is expected to obtain European Conformity (CE) certification by the end of the year. Following the recent publication of a paper in an international academic journal, the company’s entry into markets not only in South Korea but also in Russia, the Commonwealth of Independent States (CIS), and Vietnam is becoming a reality, drawing attention to its goal of launching domestic and international sales by the end of the year.

“Beyond HPV Testing to LBC”… Setting Sights on the Self-Collection Market

According to the pharmaceutical and biotech industry on the 22nd, it has been confirmed that EarlyPop recently passed the MDR conformity assessment conducted for sterile medical devices (Class I). Currently, only administrative procedures, such as the issuance of the MDR report, remain.

A representative of BIODYNE CO., LTD. stated, “In early June, EarlyPop passed the MDR conformity assessment for both self-collection and professional-use devices,” adding, “We expect it will take about four months to issue the MDR report, followed by approximately two months for the CE certification process.”

The MDR (Medical Device Regulation) is a medical device regulation implemented by the European Union (EU) characterized by significantly stricter clinical evidence and quality control standards compared to the existing CE certification system.

EarlyPop falls under Class Is, which covers sterile medical devices and requires a more rigorous conformity assessment by certification bodies than the general Class I category.

Previously, the Ministry of Food and Drug Safety approved EarlyPop as a product for professional use. If the company obtains CE certification for the self-collection product by the end of the year, it is expected to become the first in the global market to commercialize a self-collection brush based on liquid-based cytology (LBC).

EarlyPop refers to a self-collection brush designed to allow users to collect cervical cells on their own, without the assistance of a doctor at a hospital. Recently, HPV testing products utilizing self-collected specimens have been launched one after another in the global market. In fact, global diagnostic companies such as Roche and Becton Dickinson (BD) have commercialized HPV testing products that use self-collected specimens.

However, existing products have focused on detecting HPV infection, limiting their use for liquid-based cytology, which identifies morphological abnormalities in cervical cells. BIODYNE CO., LTD. has designed EarlyPop with a proprietary brush structure that ensures sufficient cervical cells—necessary for liquid-based cytology—can be collected even in a self-collection setting. BIODYNE CO., LTD. plans to launch EarlyPop as the world’s first self-collection brush based on liquid-based cytology.

The medical device industry is paying close attention to self-collection technology because it has the potential to increase cervical cancer screening rates. Since cervical cell collection is typically performed during gynecological examinations, there are many countries where women avoid screening for cultural or religious reasons. In some low- and middle-income countries (LMICs), regular screenings are difficult to conduct due to a shortage of obstetricians and gynecologists and inadequate screening infrastructure. In contrast, the self-collection method offers the advantage of improving access to screening, as individuals can collect their own samples without being limited by location.

In fact, the World Health Organization (WHO) and national health authorities are actively exploring self-collection methods as a means to increase cervical cancer screening participation rates. BIODYNE CO., LTD. expects that once the technology is applicable to liquid-based cytology, it will be able to expand beyond the existing self-collection market—which is centered on HPV testing—into the market for more precise cervical cancer screening.

Expectations are also rising for the first sale of EarlyPop within the year, as BIODYNE CO., LTD. recently signed a Memorandum of Understanding (MOU) with a local partner regarding EarlyPop.

A BIODYNE CO., LTD. official stated, “We plan to supply EarlyPop samples so that our partners in Russia, the CIS, and Vietnam can begin sales efforts. In addition, we have already signed MOUs with some university hospitals in Korea regarding the use of EarlyPop,” adding, “We expect full-scale marketing and sales activities to begin both domestically and internationally following the sample evaluation.”

Study Demonstrates Potential for ‘All-in-One Self-Collection’

BIODYNE CO., LTD. is accelerating efforts not only to navigate regulatory procedures but also to establish a solid academic foundation. The company recently secured clinical evidence to support its expansion into overseas markets following the publication of a study evaluating EarlyPop’s self-collection performance in the international academic journal *Diagnostics*. This prospective study compared EarlyPop self-collected samples with those collected by medical professionals in a cohort of 520 women.

Currently, the global self-collection market is effectively centered on HPV testing. Major self-collection devices—including Rovers’ Evalin Brush, as well as FlockSwab, BiVaBrush, and Q-BinTip—are mostly evaluated and used for HPV molecular diagnostics.

In contrast, EarlyPop is designed to enable liquid-based cytology, HPV testing, and sexually transmitted infection (STI) testing to be performed using a single self-collection sample. BIODYNE CO., LTD. explained that, based on currently published literature, this is the only study to date to have simultaneously validated all three tests using a single self-collection sample.

The study found that EarlyPop detected more lesions and HPV-positive cases than samples collected by healthcare professionals. A significant number of these additional findings were confirmed as actual lesions through biopsy. Notably, the kappa coefficient—an indicator of agreement in cytology testing—was 0.67. However, BIODYNE CO., LTD. interprets this not as a sign of inaccuracy but as a result of the detection of additional lesions.

A representative of BIODYNE CO., LTD. explained, “While a kappa coefficient of 0.67 may seem low, this is not because EarlyPop is inaccurate, but rather because EarlyPop detected additional lesions that specialists had missed,” adding, “Since these cases were confirmed as actual lesions through biopsy, we view this as a meaningful result.”

In the actual study, abnormal findings detected solely by EarlyPop were verified via biopsy in accordance with standard guidelines, and a significant number were confirmed to be actual lesions. This result overturns the prevailing perception that self-collection methods, while convenient, may have lower accuracy.

BIODYNE CO., LTD. representative said, “While the self-collection market is currently centered on HPV testing, EarlyPop stands out because it can perform liquid-based cytology, HPV testing, and sexually transmitted infection (STI) screening using a single specimen,” adding, “Building on our CE certification, we plan to accelerate our expansion into not only the Russian, CIS, and Southeast Asian markets but also global markets such as the U.S. and Europe.”