27 September 2023 [Press release]

DiagCor Life Science's GenoFlow HPV Array Test Kit Receives Saudi Arabia's Medical Device Registration Certification

On September 27, 2023, DiagCor Life Science's GenoFlow^TM 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 DiagPuro^TM Nucleic Acid Extraction System and Reagent, Genesis 96T Thermal Cycler and FT^PRO 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 GenoFlow^TM 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 theDiagPuro^TM Nucleic Acid Extraction System and Reagent, Genesis 96T Thermal Cycler and FT^PRO Auto System (or FT^PRO 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.