Wells Bio Obtains CE IVDR Certification for 8 Molecular Diagnostic Kits for Infectious Diseases

Setting a New Standard in Multiplex Infectious Disease Testing Across Europe and Beyond

Wells Bio, a specialized in vitro diagnostics company, announced on the 19th that eight of its multiplex molecular diagnostic reagents for infectious disease detection have obtained conformity certification (CE-IVDR) under the European Union’s In Vitro Diagnostic Medical Device Regulation. Wells Bio is a subsidiary of Access Bio, whose largest shareholder is PharmGen Science, and possesses key in vitro diagnostic technologies for disease detection including precision molecular diagnostics, rapid immunodiagnostics, and biosensor-based point-of-care testing.

The CE-IVDR, implemented since 2022, significantly strengthens performance, quality, and safety standards compared to the previous directive (IVDD). It is also a mandatory certification for entering the European market.

The certified reagents include six for sexually transmitted infections and two for tick-borne infections, all of which are in vitro diagnostic medical devices based on high-sensitivity, simultaneous multiplex detection Real-Time PCR technology.

A representative product, the careGENE™ STD-12 Detection Kit, can simultaneously detect 12 major pathogens that cause sexually transmitted diseases. By applying TaqMan-based diagnostic technology, the kit achieves enhanced sensitivity and accuracy. The product is currently expanding in domestic major medical institutions and has rapidly growing exports to Europe, Asia, South America, and Africa. Last year, it also entered the U.S. market after obtaining LDT approval in CLIA-certified laboratories.

The careGENE™ HPV Screening Kit H enables the identification of 14 high-risk human papillomavirus (HPV) types associated with cervical cancer, while the careGENE™ HPV Detection Kit M can analyze 7 high-risk and low-risk HPV types and screen for 18 HPV types in total.

In addition, the careGENE™ Scrub Typhus Real-Time PCR Kit and the careGENE™ SFTS Virus RT-PCR Kit are diagnostic products for scrub typhus and severe fever with thrombocytopenia syndrome (SFTS), both tick-borne infectious diseases.

Lee Min Jun, CEO of Wells Bio, stated:

“This certification demonstrates the excellence of our multiplex molecular diagnostic technology and infectious disease diagnostic reagents. Through continuous research, development, and technological advancement, we will strengthen our competitiveness and expand our market share in Europe and the global market.”