Companion Diagnostic for ALK Mutations

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N43CO201000132
Agency Tracking Number: N43CO201000132
Amount: $200,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2010
Solicitation Year: 2010
Solicitation Topic Code: NCI
Solicitation Number: PHS2010-1
Small Business Information
111 10th Ave. South Suite 110, NASHVILLE, TN, 37203-
DUNS: 190114962
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 David Hout
Business Contact
Phone: (615) 255-8880
Research Institution
Kinase inhibitors such as Gleevec and Tarceva have markedly improved cancer therapy. Essential to the use of such inhibitors are companion diagnostics enabling determination of the mutational status of th eir kinase targets in tumors. Anaplastic lymphoma kinase (ALK) fusion oncogenes have emerged as an important cause of lung cancer, and ALK inhibitor programs (by Pfizer, Lil ly, Ariad, Astell as, Zenobia, and others) are in progress, ALK inhibition causes marked anti-tumor responses, but only in patients whose tumors conta in mutant ALK. Both immunohistochemistry (IHe) and fluorescence in situ hybridization (FISH) can identify ALK mutations, but each has multiple limitations Herein, we propose development of a microarray¿based test to ident ify ALK fus ions (EML4¿ALK. NPM¿ALK, CL TC-ALK, and others) from FFPE tissues as a rapid, highly specific and sensit ive companion diagnostic. Insight Genetics has established collaborations with experts in the genetics of ALK and lung cancer, as well as collaborations with pharmaceutical companies developing ALK inhibitors. In the studies proposed, we wi ll establish and validate our ALK mutation detection platform using lung cancer specimens. many also characte rized by ALK FISH and/or IHC to benchmark our assay against these methodolog ies. The Insight Genetics ALK microarray will enable personalized therapy by caregive rs, tra ns lating to improved patient outcomes.

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

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