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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: N43CA130019
Agency Tracking Number: N43CA130019
Amount: $241,044.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: N/A
Timeline
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
2150 WOODWARD STREET SUITE 100
AUSTIN, TX 78744-1840
United States
DUNS: 622988330
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 PH.D BROWN
 (512) 681-5246
 JBROWN@ASURAGEN.COM
Business Contact
 PH.D BROWN
Phone: (512) 681-5246
Email: JBROWN@ASURAGEN.COM
Research Institution
 Stub
Abstract

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

* Information listed above is at the time of submission. *

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