On September 27, 2023, DiagCor Life Science's GenoFlowTM HPV Array Test Kit, for identification of 33 high- and low-risk HPV genotypes, has has been approved by the Saudi Arabia FDA after strict review. The reagent has obtained the Medical Device Marketing Authorization, which qualifies it to enter the Saudi Arabia medical device market in in accordance with the Medical Devices Law issued by Royal Decree No. (M/54) dated 6/7/14 4 2 HA. This follows the successful approval of the company's DiagPuroTM Nucleic Acid Extraction System and Reagent, Genesis 96T Thermal Cycler and FTPRO Auto System in June 2023.
According to the World Health Organization (WHO), cervical cancer is the fourth most common form of cancer among women worldwide, with the disease claiming the lives of almost 350 000 women in 2022. In August 2020 the World Health Assembly adopted the Global Strategy for cervical cancer elimination, outlining three key pillars (vaccination, screening, treatment) and their corresponding targets. In July 2021, the WHO released the “WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition", which recommends using HPV DNA detection as the primary screening test rather than VIA or cytology in screening and treatment.
Cervical cancer is preventable and curable, as long as it is detected early and managed effectively. In contrast to screening, which ignores the subtle persistence of specific genotypes, and often leads to over-estimation of risk and unnecessary surgeries, DiagCor Life Science's GenoFlowTM HPV Array Test Kit can monitor 33 individual genotypes over time, to ensure persistent infection by specific HPV subtypes. These detailed and reliable genotype test results can help to prevent and control cervical cancer.
Used in conjunction with theDiagPuroTM Nucleic Acid Extraction System and Reagent, Genesis 96T Thermal Cycler and FTPRO Auto System (or FTPRO Flow-through System), laboratories can complete the entire process of nucleic acid extraction, PCR amplification and hybridization in only 3 steps. The results are accurate and reliable.
About DiagCor
Headquartered in Hong Kong with ISO 13485 accredited Quality Management System, DiagCor has been dedicated solely to molecular diagnostics (MDx) since 2006. The global leader in flow-through hybridization technology, the company offers a range of products, solutions and services related to RNA and DNA analysis. As well as providing MDx laboratory services to Asia Pacific practitioners, DiagCor develops and manufactures MDx products and solutions, and offers MDx medical translation services and MDx consulting.
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