FDA Clears First BCR-ABL1 Monitoring Test for Chronic Myeloid Leukemia

Asuragen has received Food and Drug Administration (FDA) clearance for the QuantideX qPCR BCR-ABL IS kit, which is intended for monitoring treatment response and assessing disease clearance in chronic myeloid leukemia (CML) patients. With improved CML therapies like imatinib (Gleevec) and other tyrosine kinase inhibitors, an important part of disease management is monitoring levels of the BCR-ABL1 fusion transcript—a marker for the presence and amount of transcriptionally active Philadelphia-chromosome positive leukemia cells in CML patients. The QuantideX qPCR BCR-ABL IS assay is the first test that FDA has cleared for this purpose. The assay was evaluated through FDA’s de novo 510(k) premarket review pathway and secured clearance with a limit of detection of 4.7 log molecular reduction (MR) from 100% International Scale. The limit of detection was determined using real human RNA, not human-derived cell lines, ensuring that the assay reproducibly detects BCR-ABL1 RNA in ≥95% of patients at MR 4.7.

New Wave of Zika Tests Authorized for Use

As Zika continues to spread, new tests for the virus are being developed and authorized for use both in the U.S. and abroad. Most recently, the Food and Drug Administration (FDA) gave emergency use authorizations to Siemens Healthcare Diagnostics and Luminex for their respective Zika tests, while Vela Diagnostics has also received the CE mark for a Zika assay.

Both Siemens’ real-time PCR assay, the Versant Zika RNA 1.0 assay (kPCR) kit, and Luminex’s multiplex nucleic acid test, the xMAP MultiFlex Zika RNA assay, are designed to detect Zika virus RNA, which can be an earlier indicator of infection than anti-Zika antibodies. Vela Diagnostics’ real-time PCR Sentosa SA ZIKV PCR test is designed to detect the virus in samples with low Zika viral load. Vela’s test can detect 82 Zika virus strains and has a limit of detection of 3 x 103 copies/mL for the ZIKV PRAVBC59 target gene and 6 x 103 copies/mL for the ZIKV MR-766 target gene. All three tests are validated for use with plasma, serum, and urine samples.

FDA Clears Two Tests for Influenza A/B and RSV

The Food and Drug Administration (FDA) has granted 510(k) clearances to Roche’s cobas Influenza A/B & RSV test, designed for use on the cobas Liat system, and Luminex’s Aries Flu A/B & RSV assay. Both tests detect and differentiate between influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).

Roche’s test uses real-time PCR technology to target well-conserved regions of influenza A/B and RSV RNA to provide broad strain coverage. It produces results in about 20 minutes and has been validated using more than 40 common strains of influenza A and B and seven common strains of RSV. FDA has also given a CLIA waiver to the test, making Roche the first manufacturer to extend CLIA-waived molecular testing beyond flu A/B and strep A to include RSV.

Using PCR, Luminex’s qualitative test directly detects influenza A/B and RSV nucleic acid from nasopharyngeal swab specimens. The assay allows for panel customization, giving users the ability to report only the results of interest.