Dx Focus: Quidel RSV/hMPV Test Gets 510(k); Labceutics, Asuragen Partner on BCR-ABL1 Standardization
Quidel said this week that it has received 510(k) clearance from the US Food and Drug Administration for its Quidel Molecular RSV + hMPV assay for the detection of respiratory syncytial virus and human metapneumovirus.
Labceutics and Asuragen announced this week that that they will conduct an international, multi-center quality assurance study to track standardization across labs conducting BCR-ABL1 testing on the International Scale.
Asuragen will develop Armored RNA Quant BCR-ABL1 RNA International Scale calibrators and laboratory software reporting tools to help laboratories standardize testing when treating Philadelphia chromosome-positive chronic myelogenous leukemia patients with Novartis' Gleevec.
Asuragen is developing BCR-ABL calibrators that "are intended to be compatible with several widely used assays," as well as a software reporting tool that is "expected to help standardize how BCR-ABL1 RT-qPCR results are reported according to the International Scale."