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IGF::OT::IGF OTHER FUNCTIONS - RandD BIOMEDICAL (BASIC RESEARCH)

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2012 / SBIR
Agency Tracking Number:
N43CO120086
Solicitation Year:
2012
Solicitation Topic Code:
NCI
Solicitation Number:
Small Business Information
INSIGHT GENETICS, INC.
111 10th Ave. South Suite 110 NASHVILLE, TN 37203-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2012
Title: IGF::OT::IGF OTHER FUNCTIONS - RandD BIOMEDICAL (BASIC RESEARCH)
Agency: HHS
Contract: N43CO120086
Award Amount: $199,576.00
 

Abstract:

Lung cancer is the main cause of cancer mortality worldwide with 80% non-small cell lung cancer (NSCLC) in type and mainly driven by three mutually exclusive oncogenes, EGFR, KRAS and ALK (collectively between 30-60% of all NSCLC cases). Oncogenic driverssuch as ROS1 and RET fusions and DEPDC1 over-expression have been identified as clearly recurrent, collectively constituting up to ~12% of all NSCLC cases. Preclinical studies have demonstrated ROS1-driven cancers to be exquisitely sensitive to small-molecule tyrosine kinase inhibitors (TKIs) as well as Hsp90 inhibitors that are now under development by several pharma and biotech firms. Similarly, ambiguous TKI treatments have also been used against non-NSCLC RET and DEPDC1 driven cancers in ongoing Phase Iand Phase II clinical trials with good efficacy. These trials should encourage numerous pharmaceutical companies to follow suit and conduct similar clinical trials using therapeutics specifically targeting RET and DEPDC1-driven NSCLC. Unfortunately, no regulatory-approved, high-throughput commercial diagnostic tests are readily available to reliably and efficiently diagnose ROS1 or RET fusions nor DEPDC1 over expression in NSCLC patients. We propose to complete the development and validation of both a comprehensive panel of quantitative polymerase chain reaction (qPCR)-based assays and a fluorescence in situ hybridization (FISH) assay to collectively be used as a broad-based NSCLC detection panel to classify a previously unidentified, yet significant, cohort of NSCLC patients readily treatable with available therapeutics. All validations will establish clinical utility by ultimately testing a large cohort of clinical specimens to unequivocally demonstrate statistical significance for sound patient selectionof inhibitor therapy. All potential companion diagnostics will then enter co-development with an IVD partner for full commercialization of each assay as a FDA-approved companion diagnostic.

Principal Investigator:

Dr. david Hout
615-255-8880
DHOUT@INSIGHTGENETICSINC.COM

Business Contact:

Dr. david Hout
615-255-8880
DHOUT@INSIGHTGENETICSINC.COM
Small Business Information at Submission:

INSIGHT GENETICS, INC.
2 International Plaza Drive Suite 510 NASHVILLE, TN 37217

EIN/Tax ID: 120212289
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No