Sansure Biotech Inc., a molecular diagnostics specialist based in China and listed on the Shanghai Stock Exchange (SHA: 688289), has announced that it has received marketing approval from the National Medical Products Administration for its human papillomavirus (HPV) nucleic acid detection kit. This kit, which uses the PCR fluorescent probe method, is designed for the in vitro qualitative detection of high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, and 68 DNA in female cervical epithelial cell samples. Notably, it can also simultaneously classify and identify high-risk HPV types 16 and 18. This marks the product as the only screening product currently available in China that covers 15 common high-risk types of HPV.
This diagnostic tool is primarily intended for screening patients who have returned ASC-US (atypical squamous epithelial cells of uncertain significance) results in cervical cytology examinations, helping to determine the necessity of further vaginal colposcopy. For women aged 30 and above, it aids in cervical cancer screening by testing for high-risk HPV infection in conjunction with cervical cytology examination. The test integrates the assessment of cytological history, other risk factors, and aligns with clinical diagnostic and treatment protocols, as well as screening guidelines, to inform patient management. This comprehensive approach supports medical professionals in making informed decisions regarding patient care.- Flcube.com
