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[junkie-alert style=”red”] Asuragen, Inc., a molecular diagnostics company changing the way diagnostics impact patient care in genetics and oncology, announced today the availability of their CE-marked QuantideX® qPCR BCR-ABL minor Kit*. Building on its best-in-class FDA-cleared and CE-marked QuantideX® qPCR BCR-ABL IS Kit for quantifying Major (e13a2, e14a2) BCR-ABL1 fusion transcripts in patients with chronic myeloid leukemia (“CML”), the addition of the QuantideX® qPCR BCR-ABL minor Kit allows laboratories to also quantify minor (e1a2) BCR-ABL1 fusion transcripts. [/junkie-alert]
Asuragen’s products are diagnostic systems composed of proprietary chemistry and software to deliver powerful answers using broadly installed instrument platforms. The simplicity, reliability and performance of its tests make it easy for laboratories to adopt. The QuantideX® BCR-ABL Portfolio provides laboratories with robust, reliable and comprehensive solutions for monitoring leukemia patients, allowing them to keep pace with advances in tyrosine-kinase inhibitor (“TKI”) therapy. Key benefits of the kits include unsurpassed sensitivity, simplified workflow, multiplexed assay design using a single reaction to amplify and detect both fusion transcripts and controls, and Armored RNA®-based standards that provide an accurate RNA quantification.
The QuantideX® qPCR BCR-ABL IS Kit and QuantideX® qPCR BCR-ABL minor Kit offer validated clinical sensitivities that detect residual amounts of disease down to 0.002% IS (MR4.7 LOD) and 0.0025% ratio (LR4.61), respectively, both determined using human RNA. The simple, streamlined and common workflow of both kits permits laboratories of all sizes to offer high quality, routine BCR-ABL1 testing.
As part of the diagnostic system, Asuragen will also be expanding the capabilities of QuantideX® Reporter, the analysis software that accompanies the CE-marked QuantideX® qPCR BCR-ABL IS Kit, to allow laboratories access to exceptional clinical sensitivity for reporting CML patient disease burden on the International Scale (“IS”) after reviewing ABL1 copy number, compliant with European LeukemiaNet (“ELN”) guidelines.
Principal Clinical Scientist at Western General Hospital in Edinburgh, UK, Anne Sproul notes, “Having the BCR-ABL minor Kit helps our lab as we have an occasional p190 positive CML patient.” We can fit both p210 and p190 samples on the same plate, the workflow from RNA to IS reporting is simplified, and the internal controls validated to the IS mean that we do not have to re-validate our assay annually. The addition of ABL1 copy number will allow our European clinicians to evaluate the quality of the specimen for themselves and keeps us compliant with ELN guidelines.”
Regarding sustained responses to TKI Therapy, Matthew McManus, MD, PhD, Asuragen’s President and CEO said, “For CML patients with sustained responses to TKI therapy, the goal of treatment-free remission is gaining momentum in the clinical community. Monitoring during therapy cessation will require accurate, reproducible, and highly sensitive measurement of disease burden.” He concluded, “The expanded QuantideX® BCR-ABL portfolio demonstrates our commitment and focus on changing how diagnostics impact care.”
*CE-marked for US export only.