Asuragen launches new response monitoring kit for CML


US-based molecular diagnostics firm Asuragen has launched the QuantideX qPCR BCR-ABL minor Kit designed to monitor molecular response in patients with chronic myeloid leukaemia (CML).

Based on its predecessor, QuantideX qPCR BCR-ABL IS Kit, which quantifies major BCR-ABL1 fusion transcripts in the disease, the new kit will measure minor BCR-ABL1 fusion transcripts.

Asuragen diagnostic systems feature a combination of chemistry and software to provide simple and reliable performance through instrument platforms.

The QuantideX BCR-ABL line is intended to allow laboratories to monitor patients with leukaemia, enabling them to obtain the latest tyrosine-kinase inhibitor (TKI) treatments.

With multiplexed assay design, the kits use a single reaction to identify fusion transcripts and controls, while their Armored RNA-based standards ensure precise RNA quantification.

"The expanded QuantideX BCR-ABL portfolio demonstrates our commitment and focus on changing how diagnostics impact care."

Asuragen president and CEO Matthew McManus 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.

“The expanded QuantideX BCR-ABL portfolio demonstrates our commitment and focus on changing how diagnostics impact care.”

Both the major and minor kits are reported to possess clinical sensitivities that can identify even 0.002% and 0.0025% ratio of residual disease amounts using human RNA.

Following a review of ABL1 copy number, the firm is also increasing the capabilities of QuantideX qPCR BCR-ABL IS Kit’s accompanying analysis software QuantideX Reporter to enable reporting of accurate clinical sensitivity for CML patient disease burden.