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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.

The assay distinguishes between RSV and hMPV, viruses that cause respiratory infections with very similar symptoms. In general, the Quidel Molecular product line comprises PCR reagent kits for use by molecular diagnostic laboratories with their existing molecular testing infrastructure, such as Life Technologies' Applied Biosystems 7500 Fast Dx thermocycler.

The reagents provide simple transport and refrigerated (non-freezer) storage, convenient workflow, and short time to result, Quidel said. Because they share a common extraction protocol, the RSV + hMPV assay can be batched alongside other Quidel Molecular assays in the same multi-well panel for customized multiplexing capability.

The RSV + hMPV assay launched in Europe shortly after receiving the CE Mark last March. It is Quidel's third molecular PCR assay to receive 510(k) clearance. The company previously received FDA clearance for Quidel Molecular assays for Influenza A+B and hMPV. Quidel also received FDA clearance for its AmpliVue isothermal amplification-based Clostridium difficile assay in December.

Labceutics said this week that it has partnered with Asuragen to conduct an international multi-center quality assurance study on the standardization of BCR-ABL1 quantitative measurements on the International Scale.

The study will assess the inter-laboratory variability of molecular monitoring results in chronic myeloid leukemia patients treated with imatinib or second-generation tyrosine kinase inhibitors. Labceutics will perform, analyze, and report the study and Asuragen will provide analytical reference materials calibrated to the primary international reference standards of the World Health Organization, the BCR-ABL1 ARQ IS Calibrator Panels.

Molecular testing for the BCR-ABL1 fusion gene by real-time qPCR is the most sensitive routine approach for monitoring the response to therapy of patients with CML. In the context of TKI therapies, the technique is most appropriate for patients who have achieved cytogenetic response and can be used to further define specific molecular response levels associated with therapeutic milestones. Harmonization of the various laboratory procedures and reporting methods utilized worldwide is essential to standardize optimal treatment response criteria and facilitate comparison across laboratories and patients, the companies said.