▲ ‘Gain Pad’ approved by the US FDA as a medical device (Source = BL Science)
BL Science, a subsidiary of BL Pharmtech, announced on the 4th that it has received FDA medical device approval for ‘Gain Pad’, a self-diagnosis kit for women’s diseases.
‘Gain Pad’, which has been approved as a medical device by the FDA, is a sanitary pad-type test kit developed by ‘BL Science’, a company specializing in in vitro diagnostic medical devices and molecular diagnostics.
‘Gain Pad’ can diagnose human papillomavirus (HPV), the cause of cervical cancer in women, and sexually transmitted infections (STD) that cause vaginitis and sexually transmitted diseases.
In particular, it is a medical device that purchases a test kit without visiting a hospital, collects a sample by yourself, and sends only the kit to an analysis institution to receive test results.
A company official said, “Gain Pad’s test method is a completely non-invasive diagnostic kit that can be safely and easily self-tested, and the accuracy of the test is also high. In addition, it has the advantage that women who avoid examinations due to visits to obstetricians and gynecologists and earthquakes can receive privacy protection without feeling repulsive.”
In recognition of such competitiveness, ‘Gain Pad’ won the ‘Jang Yeong-sil Award’, the highest authority in the field of science and technology in 2018, and was selected as a ‘next-generation world-class product’ by the Ministry of Trade, Industry and Energy.
BL Pharmtech expects that ‘Gain Pad’ will be able to grow meaningfully in the US market due to the uniqueness of the US medical environment.
In the United States, in order to receive a diagnosis of a woman’s disease using the conventional method, it is necessary to go through treatment procedures such as connection and treatment to an obstetrician and gynecologist after consultation with the attending physician, request for examination by a testing agency, and notification of the results. Due to such a complex procedure, it may take up to 2-3 months to reach the final treatment.
However, the company explained that the gain pad test can greatly improve user convenience as it can receive notification of test results via e-mail or social media within a few days.
An official from BL Science said, “This FDA registration is meaningful in that we have a bridgehead not only to enter the US market but also to enter the global in vitro diagnostic market.” We are negotiating for that,” he said.