Qiagen is happy to announce the launch of the next CE-IVD assay for our PHC blood cancer portfolio: The ipsogen BCR-ABL1 Mbcr RGQ RT-PCR kit.

The ipsogen BCR-ABL1 Mbcr RGQ RT-PCR kit is an in-vitro diagnostic test to quantify the BCR-ABL1 fusion gene b3a2 (e14a2) and b2a2 (e13a2) transcripts in total RNA extracted from whole blood. It uses the RNeasy kit for extraction and runs on the Rotor-Gene Q MDx.

This is the first commercial kit to provide deep molecular response status for BCR-ABL1 transcripts present in patients diagnosed with chronic phase Philadelphia chromosome positive (Ph+) p210 chronic myeloid leukemia (CML). To achieve deep molecular response, quantification down to a limit of detection (LOD) lower than 0.0030% is required. The new ipsogen BCR-ABL1 Mbcr RGQ RT-PCR kit is hence the most sensitive commercial leukemia test on the market.
Such low levels of sensitivity are in-line with the latest oncohematology expert recommendations for the management of CML. If a patient under latest generation tyrosine kinase inhibitor therapy (e.g nilotinib) achieves deep molecular response, the levels of BCR-ABL1 in the blood are 4.5 logs, or 10,500 times, lower than they were before the treatment started. These patients are then considered to be in remission, and after a period of time may have the option of living free of drug therapy. This is another good example how QIAGEN sample-to-insight solutions can impact the treatment of life-threatening diseases such as leukemia and help to provide best therapy options for patients.