OTHER FUNCTIONS DEVELOPMENT OF A COMPANION DIAGNOSTIC FOR ALK MUTATIONS.

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N44CO120047
Agency Tracking Number: N44CO120047
Amount: $1,495,220.00
Phase: Phase II
Program: SBIR
Awards Year: 2012
Solicitation Year: 2012
Solicitation Topic Code: NCI
Solicitation Number: N/A
Small Business Information
INSIGHT GENETICS, INC.
2 International Plaza Drive, Suite 510, NASHVILLE, TN, 37217
DUNS: 190114962
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 DAVID HOUT
 (615) 255-8880
 DHOUT@INSIGHTGENETICSINC.COM
Business Contact
 DAVID HOUT
Phone: (615) 255-8880
Email: DHOUT@INSIGHTGENETICSINC.COM
Research Institution
 Stub
Abstract
Constitutively activated forms of ALK caused by genetic aberrations have been shown to cause an expanding variety of human cancers. The FDA recently approved the Pfizer drug Xalkori (crizotinib) to treat patients with non-small cell lung cancers (NSCLC) that express ALK. Numerous other pharmaceutical companies (ARIAD, Novartis, Synta, Xcovery, others) have ongoing ALK small-molecule inhibitor programs. The current diagnostic standard an ALK break-apart FISH assay has low sensitivity and is difficult tointerpret, creating a precarious situation for clinicians attempting to select the proper patients for ALK inhibitor treatment. Insight Genetics has therefore designed a qPCR platform, Insight ALK Screen , to provide highly sensitive and unambiguous identification of the complete spectrum of oncogenic ALK. During Phase I development, Insight ALK Screen was shown to be agnostic with regard to the 5 fusion partner of ALK, highly sensitive in cell line dilution studies, and highly specific in FFPE NSCLC patient specimens. Phase II will demonstrate clinical utility of the assay by testing a large cohort of clinical specimens to unequivocally demonstrate statistical significance in sound patient selection for ALK inhibitor therapy. The product will then enter co-development with IVD partner, QIAGEN, for commercialization of the assay as a FDA-approved companion diagnostic.

* information listed above is at the time of submission.

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