Shanghai GeneoDx Biotech Co., Ltd, a medical diagnosis unit of Sinopharm, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its “human ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 gene methylation detection kit (fluorescent PCR method).” This marks the first approval in China for a cervical cancer HPV primary screening methylation shunting product.
Product Details
The product uses a methylation – specific PCR method to detect the methylation status of six genes in human cervical exfoliated cells. This helps determine whether further colposcopy is needed for individuals who have been initially screened for HPV. If the test result is negative, it indicates no cervical lesion or a low – grade lesion, allowing patients to avoid colposcopy and tissue biopsy and opt for regular follow – up instead. A positive result suggests a high – grade cervical lesion, necessitating further colposcopy and/or tissue biopsy.
Advantages Over Cytology
Compared with traditional cytology, the sensitivity of this product is non – inferior, but its specificity is significantly better. Using this product for shunting can reduce the need for colposcopy in over 60% of the population (approximately 40 million women), offering a more accurate and efficient cervical cancer screening method and reducing the physical, psychological, and economic burden on patients.-Fineline Info & Tech
