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Last $0.35 USD
Change Today +0.015 / 4.55%
Volume 107.6K
RGDX On Other Exchanges
Symbol
Exchange
NASDAQ CM
As of 11:05 AM 06/2/15 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

1640 Marengo Street

7th Floor

Los Angeles, CA 90033

United States

Phone: 323-224-3900

Fax: 323-224-3096

Response Genetics, Inc., a life sciences company, is engaged in the research and development of clinical diagnostic tests for cancer. The company sells its ResponseDX diagnostic tests and provides clinical trial testing services to pharmaceutical companies. The company’s proprietary technologies enable it to extract ribonucleic acid (RNA) and deoxyribonucleic acid from tumor specimens that are stored as formalin-fixed and paraffin-embedded (FFPE) specimens and thereby to analyze genetic information contained in these tissues. Its technologies also enable the company to use the FFPE patient biopsies for the development of diagnostic tests. Tests Launched During 2013, the company added four additional tests to its ResponseDX offering, such as HER2 mutation detection, KIT mutation detection, MET FISH (Fluorescence in Situ Hybridization), and UGT1A1 SNP. In addition, it expanded its suite of profiles to include ResponseDX: Thyroid. HER2 Mutation Detection: In 2013, the company launched testing for HER2 mutations in non-small cell lung cancer (NSCLC). Activating mutations within the tyrosine kinase domain of the HER2 gene exist within a subset of NSCLC patients, and recent clinical studies suggest that NSCLC patients carrying these mutations might benefit from HER2-targeting therapies, such as trastuzumab and afatinib. The company’s Sanger sequencing based HER2 mutation detection test could be performed for patients for whom the company has stored a residual nucleic acid sample. cKIT Mutation Detection: In 2013, the company also began offering cKIT mutation detection in its ResponseDX: Melanoma and ResponseDX: Gastric panels. The company’s cKIT assay is a Sanger sequencing based test aimed to identify cKIT mutations, which are to be a major oncogenic event in melanoma and gastrointestinal stromal tumors (GIST). Imatinib (Gleevec), an oral tyrosine kinase inhibitor initially developed for treatment of chronic myelogenous leukemia, has been shown to inhibit cKIT. Mutations in cKIT have been proven to be predictive of response to imatinib and other drugs for both GIST and melanoma. Sunitinib, another tyrosine kinase inhibitor that targets cKIT, is approved for use with imatinib-resistant GIST, among other tumor types. MET Gene Amplification (FISH): Amplification of MET is associated with poor patient prognosis in NSCLC, brain, breast, colorectal, gastric, and head and neck carcinomas, and associated with resistance to radiotherapy in NSCLC patients and with resistance to anti-EGFR therapies in both colorectal and lung carcinomas. In 2013, the company introduced a FISH test for MET gene amplification, which replaces its previous RNA expression assay for cMET. UGT1A1 Test: In 2013, the company added UGT1A1 testing to its ResponseDX: Colon panel. UGT1A1 is the primary enzyme for the clearance of the chemotherapy drug irinotecan, which is administered to metastatic colorectal cancer patients. Certain polymorphisms in the UGT1A1 gene are associated with increased potential for adverse clinical outcomes upon treatment with irinotecan, including neutropenia and elevated levels of diarrhea, and the U.S. Food and Drug Administration (FDA) provides guidelines on prescribing irinotecan based on UGT1A1 genotyping prior to therapy. The company added five additional tests to its ResponseDX offering, such as ROS1 FISH, ROS1 RT-PCR, c-MET, HER2 FISH, and VEGFR2. In addition, it made its NRAS assay available to its ResponseDX: Melanoma offering after publications showed that NRAS mutational status might be predictive for BRAF inhibitor response in metastatic melanoma patients. Technologies ResponseDX: Lung, ResponseDX: Colon, ResponseDX: Gastric, ResponseDX: Melanoma, ResponseDX: Thyroid, and ResponseDX: Breast The company developed ResponseDX in part by using its technology to extract genetic information from FFPE tumor specimens. Its technology provides gene expression, mutation detection and gene amplification/rearrangement information for each patient’s tumor tissue specimen. ResponseDX: Lung comprises tests grouped into ‘Driver’, ‘Expanded Driver’, and ‘Academic’ profiles. The Driver profile includes EGFR

 

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