Shanghai Rightongene Biotechnology Co., Ltd (SHA: 688217), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its BCR-ABL P210 fusion gene detection kit, which uses the fluorescence reverse transcription polymerase chain reaction (RT-PCR) method. The kit is designed for the in vitro quantitative detection of the leukemia-related fusion gene BCR-ABL P210 RNA in peripheral blood samples from patients with chronic myeloid leukemia (CML), as well as for monitoring the response to CML treatment.
Having previously obtained two Category III device approvals in the field of leukemia, Rightongene Bio’s latest approval is recognized as the sole Category III device approval for quantitative tracking and screening in leukemia within China.- Flcube.com