Wells Bio, a subsidiary of Access Bio, said Wednesday that it has received sales approval for its careGENE™ HPV screening kit-H, a human papillomavirus (HPV) screening kit, from the Ministry of Food and Drug Safety.
The kit is a one-step diagnostic kit that can detect high-risk HPV types 16, 18 and 12, which are major risk factors for cervical cancer, using viral nucleic acid extracted from a cervical swab.
Cervical cancer is the fourth most common cancer among women in the world, and seventh most common cancer in Korea and more than 99 percent start from an HPV infection. Of the more than 100 types of HPV, type 16 and 18 accounts for more than 70 percent of the cases.
In addition to the existing Pap smear method, experts have recognized molecular screening tests (DNA tests) that can select high-risk HPV types as an essential tool to prevent disease.
“We have demonstrated the superiority of the product performance through our recent clinical trials,” a company official said. “We are planning to advance into the domestic market by securing a foothold for applying our products to HPV screening tests in hospitals through the approval of this diagnostic kit.”
Also, as the age at which the recommended screening of domestic cervical cancer has been lowered from 30 to 20 years old, the company expects that the HPV screening diagnostic market will grow at home and abroad, he added.
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