A molecular diagnostic kit for human papillomavirus (HPV) independently developed by Wells Bio has received marketing approval by Korean health authorities, the company’s parent Access Bio said on Monday.

The new test dubbed ‘careGENE™ HPV detection kit-M’ is an in vitro diagnostic medical device that helps diagnose HPV infection by detecting DNA extracted from a woman’s cervical cell sample using real-time PCR technology.

Some types of HPVs can cause several cancers, including cervical cancer.

The test was designed for targeting 25 HPV types with high prevalence in Central and South America.

Data from a clinical trial conducted in Korea showed excellent clinical performance, with over 90 percent in sensitivity and 98 percent in specificity. Another advantage is that it has a low-concentration detection capability that can detect the virus even if only 10 DNAs are present in a sample.

Wells Bio plans to accelerate its entry into the Latin American market, where demand for HPV testing is high. In Latin America, about 60,000 women are diagnosed with cervical cancer every year, with half of them dying.

According to data, the global HPV diagnosis-related market is estimated at about 1 trillion won, with an average annual growth rate of 8.6 percent. Latin America accounts for 9 percent of global demand. Wells Bio plans to launch the product in the fourth quarter of this year and offer the product to the global market, starting with Latin America.

Wells Bio is a subsidiary of Access Bio, a Kosdaq-listed U.S. corporation acquired by Pharmgen Science, focused on diagnostic product development and production.

By Lee Byung-moon and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]