WellsBio Obtains Domestic Approval for Human Papillomavirus Diagnostic Reagent

WellsBio Human Papillomavirus Diagnostic Reagent.

[Asia Economy Reporter Lee Gwan-joo] WellsBio, a subsidiary of Access Bio, announced on the 19th that its independently developed human papillomavirus (HPV) molecular diagnostic kit, 'careGENE™ HPV detection kit-M,' has obtained domestic approval.

This product is an in vitro diagnostic medical device that helps diagnose HPV infection by detecting DNA extracted from liquid-based cervical cytology specimens of women using real-time polymerase chain reaction (Real-time PCR).

It was designed by selecting 25 types of HPV with high prevalence in the Latin American region, enabling simultaneous detection to enhance user convenience and diagnostic testing efficiency. Clinical trials conducted domestically showed performance exceeding 90% sensitivity and 98% specificity. It also has low-concentration detection capability, able to detect even when only 10 DNA copies are present per test.

HPV is a common virus that causes warts on the human body, with over 100 types identified to date. Among these, types classified as high-risk can cause various cancers, including cervical cancer.

WellsBio plans to accelerate its entry into the Latin American market, where demand for HPV molecular diagnostic reagents is high. Latin America is a region with a rising screening rate trend, where approximately 60,000 women are diagnosed with cervical cancer annually, and about 30,000 of them die.

A WellsBio official stated, “More than 600,000 women worldwide are diagnosed with cervical cancer annually, and over 300,000 die, highlighting the growing importance of early diagnosis through excellent diagnostic reagents,” adding, “With this domestic approval, we will not only successfully launch domestically but also actively pioneer the Latin American market through collaboration with our US-headquartered parent company, Access Bio.”

WellsBio is a diagnostic product specialized development and manufacturing company established in 2013 for next-generation diagnostic product development. It is a subsidiary of Access Bio, a US corporation listed on KOSDAQ, whose largest shareholder is PharmGen Science.

This content was produced with the assistance of AI translation services.