GenDx Biotech Secures Indonesian Import License for GENEYE® HPV ERA Assay.
updated time:2025-04-25
updated time:2025-04-25
Recently, GenDx Biotech self-developed rapid molecular diagnostic test assay for HPV, utilizing vaginal swab samples, was awarded an import medical device license by the Indonesian government. This milestone marks the recognition of GENEYE® ERA Technology by the Indonesian government.
As a Chinese company with the global exclusive patent for ERA technology, GenDx Biotech has pioneered a Easy, Rapid and Accurate nucleic acid detection solution. With the characteristics of delivering results in 20 minutes and being fully enclosed without the need to open the lid after sampling, it has gained favor in the Indonesian market and provided more comprehensive support for global HPV prevention and control efforts.
In the Guidelines for Screening and Treatment of Cervical Precancerous Lesions released by the World Health Organization (WHO) in 2021, it is explicitly stated that HPV-DNA testing should serve as the preferred method for primary screening of cervical cancer. Guidelines from institutions such as the American College of Obstetricians and Gynecologists (ACOG), the European Research Organization on Genital Infections and Neoplasms (EUROGIN), and China’s National Health Commission, along with large-scale studies, all support HPV testing as the preferred primary screening method. Practices in China and other countries have also demonstrated its feasibility. In the future, with technological iterations and policy support, HPV molecular diagnostics will play a more critical role in global cervical cancer prevention and control.
Facing this global challenge, GenDx Biotech has launched a rapid molecular diagnostic reagent for HPV testing using vaginal swab samples. The GENEYE® HPV ERA Assay combines high performance, low cost, speed, and convenience, making it an ideal choice for home testing and highly effective in resource-limited primary healthcare settings.
