PANAGENE Inc. a genetic molecular diagnostic company, reported that PANA Realtyper™ HPV screening Kit received a medical device item approval from the Ministry of Food and Drug Safety.

PANA Realtyper™ HPV screening kit is a medical device for in-vitro diagnostic analysis that is qualitatively detected by real-time PCR.

A single test can detect 14 high-risk groups of HPV (Genotyping 16,18 / Screening 31,33,35,39,45,51,52,56,58,59,66,68), two major risk factors for cervical cancer, and 2 low-risk groups (Genotyping 6,11) for vaccine prescription.

The need for a first-line primary screening test to identify the risk of cervical cancer is emerging worldwide, and it is expected that the market for HPV screening diagnostics will grow as the existing uterine cell test method is replaced by more accurate and sensitive molecular diagnosis.

PANAGENE Inc. PANA Realtyper™ HPV Screening Kit is designed for overseas markets in line with this trend. It is suitable for screening diseases because the HPV kit can easily detect high-risk groups in a single reaction.

In the future, Korea is expected to increase the necessity of screening kits that can easily replace the cell test method as the global trend is. However, in consideration of the practical needs of domestic clinical sites, PANAGENE Inc. reported that it was developed to detect low-risk groups, which are currently targeted for cervical cancer vaccine prescription.

An official from PANAGENE Inc said, "We plan to expand into overseas market with our HPV screening product, launched together with our STD diagnosis product."

Also, "We will do our best to be recognized in the global infectious disease market with PANAGENE’s technology in cancer-related molecular diagnosis."