Bio-Rad PCR system and CML detection kit have been approved by FDA.

  • 2019-02-16

As a leader in life science and clinical diagnosis, Bio-Rad Laboratories Inc. recently announced that QXDx AutoDG ddPCR system (QX200 Droplet Digital PCR Dx system) and QXDx BCR-ABL%IS kit have been approved by FDA. According to information, it is the first digital PCR product that has been approved by FDA. In the past year, QXDx BCR-ABL%IS kit had also been approved by CE-IVD. Joint application of this digital PCR system and kit can help precisely detect the molecular reaction in chronic myeloid leukemia patients.

Annette Tumolo, Bio-Rad EVP and President of Life Science Group, announced proudly to possess the first FDA-cleared liquid biopsy test in oncology.“It is understood that QXDx AutoDG ddPCR system and QXDx BCR-ABL %IS are the first digital PCR method to detect and quantify the molecular reaction to tyrosine kinase inhibitor (TKI) in CML patients.”

Notably, QXDx AutoDG ddPCR is both applicable in clinical in vitro diagnosis and scientific research in laboratories.