SBIR TOPIC 315: DEVELOPMENT OF COMPANION DIAGNOSTICS: ENABLING PRECISION MEDICINE

Asuragen is developing a sensitive, accurate, and reliable test (BCR-ABL1 RT-qPCR Test), for quantification of BCR-ABL1 fusion transcripts to monitor residual disease in patients with chronic myeloid leukemia (CML). Molecular testing for the presence and relative amount of the BCR-ABL1 translocation marker is important for risk stratification and for detecting a loss of response or suboptimal response to therapy. CML patients undergoing tyrosine kinase inhibitor treatment are monitored every 3 months because of the prognostic value of BCR-ABL1 relative expression levels. Early identification of treatment failure allows for a revised, potentially life-saving, therapeutic strategy. The BCR-ABL1 RT-qPCR Test offers a sensitive assay design with superior controls and innovative standards and improves laboratory operations for cost saving. To improve the availability of accurate, reliable testing, our goal is to gain regulatory approval as an FDA-cleared IVD. During phase I we will complete the development of theBCR-ABL1 RT-qPCR Test, incorporating control materials traceable to the WHO primary standards and completing internal design verification testing. PUBLIC HEALTH RELEVANCE