NeoDx Biotech Labs Pvt Ltd announces BCR ABL Product Launch

Summary: BCR-ABL1 translocation is detected in 90-95% of chronic myelogenous leukemia (CML) cases. Detection of the BCR-ABL translocation not only aids the initial diagnosis of CML but is also useful for monitoring tyrosine kinase inhibitor response status and monitoring minimal residual disease (MRD).

NeoDx Biotech Labs, an IVD Developer, and manufacturer, has expanded its portfolio with the BCR-ABL Range of Real-Time PCR Detection Kit, an in-vitro diagnostic product for aiding in the diagnosis of Chronic Myeloid Leukemia (or CML) and monitoring TKI response.

The World Health Organization (WHO) classifies CML as a “myeloproliferative neoplasm,” a type of disease in which the bone marrow makes too many white blood cells. CML usually gets worse over time, as the extra cells build up in the blood and/or bone marrow. The accumulation of WBCs may eventually cause fatigue, bleeding, and other problems.

The GLOBOCAN 2020, reported 19.2 million new cancer cases and 9.9 million deaths globally. By 2040, cancer incidence and mortality are expected to rise to 29.5 million and 16.3 million, respectively.

BCR-ABL1 translocation is detected in 90-95% of CML cases. A portion of the ABL1 gene from chromosome 9 translocates and fuses with the remaining portion of the BCR gene on chromosome 22. The translocated piece of chromosome 9 results in an oncogene called BCR-ABL1 t(9;22)(q34;q11) (BCR-ABL1: BCR - Breakpoint cluster gene; ABL1 - Abelson Kinase 1), also known as the “Philadelphia chromosome.”

The breakpoint in the BCR gene influences the size of the fusion protein encoded by BCR-ABL. To date, Three breakpoint cluster regions have been characterized: Major (M-bcr), Minor (m-bcr), and Micro (µ-bcr).

NeoDx’s BCR-ABL Qualitative and Quantitative is a one-step, multiplex format along with ABL amplification in a single tube. It eliminates the need for additional cDNA conversion and detects all three Major, Minor, and Micro transcripts.

The Quantitative kits were standardized using WHO reference standards, so as to allow an analysis of deep molecular response up to 4.5 log reduction. The assay run time for both qualitative and quantitative is under 90 minutes.

While developing the kit was a challenge, NeoDx’s team of scientists said “We wanted to design a product that would help healthcare professionals better understand their patient’s prognosis; thereby supporting the overall treatment outcomes for the patients.”

“High or rising BCR-ABL RNA levels may increase the risk of leukemic relapse and drug-resistance mutations during TKI therapy. Our kit design eliminates the cDNA step, a feature that ensures that doctors get quick results that can help them make treatment decisions.”

NeoDx’s BCR ABL Kit is a CDSCO-approved IVD Kit that identifies over 14 BCR-ABL Major transcripts making it one of the most unique indigenously developed kits.