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Address:
Gentris Corporation
133 Southcenter Court, # 400
Morrisville, NC 27560
Phone:(919) 465-0100
Website:http://www.gentris.com
COMPANY INFORMATION
Gentris Corporation is a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions. As pioneers in the field of pharmacogenomics, Gentris helps pharmaceutical companies and clinical research organizations effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective compounds to the market more quickly.
Gentris is developing diagnostic test kits and validated reference controls that will bring the promise of personalized medicine to physicians and patients, which will enhance patient management, improve patients' response to therapy and revolutionize medicine through pharmacogenomics.
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OVERVIEW
Gentris Corporation is transforming global drug development with clinical pharmacogenomic solutions that can accelerate drug development and significantly reduce costs, resulting in more predictable response to drug therapy and less frequent, less severe adverse drug reactions (ADRs).
For every 5,000 drug candidates that enter pre-clinical testing, the Food and Drug Administration will approve only one. As a result, pharmaceutical organizations are under pressure to reduce costs and to address the key reasons for drug failure - ADRs, lack of efficacy and unfavorable pharmacokinetics/drug metabolism properties.
ADRs are currently the fourth leading cause of death and the fifth leading cause of illness in the United States. Gentris helps reduce this statistic with clinical pharmacogenomic testing that will identify patients that may exhibit drug intolerance earlier in the development cycle. With better characterization of patient populations, pharmacogenomics can help reduce drug failure rates by enabling drug companies to modify patients' exposure to drugs based on their drug-response genotype. This can offer the added benefit of making drugs that might otherwise not be approved or withdrawn to become available to patients with compatible pharmacogenomic profiles. Other benefits include shorter and more focused clinical trials that offer the promise of getting drugs to market faster, with higher safety profiles and at lower cost.
Company Mission
Gentris Corporation will lead the new paradigm in healthcare by enabling the administration of medication based on individual genetic variation by offering high quality pharmacogenomic laboratory testing services and diagnostic products.
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Services
Gentris Clinical Genetics performs clinical pharmacogenomic testing services in
a GLP and CLIA-compliant laboratory environment that exceeds the standards for
quality, reliability and consistency. Our clients have the assurance that the
data generated to support their clinical trials is robust and will meet
regulatory submission standards.
Extensive validation procedures and a comprehensive Quality Assurance program support our success rate in repeatedly passing rigorous on-site client audits.
Nucleic Acid Extraction and Purification
- High throughput proven methods to extract DNA or RNA from a variety of samples
- High quality and yield - test immediately or store for future analysis
- Stringent integrity checks performed
Nucleic Acid Banking and Repository
- Creates an inexpensive safeguard for drug development programs - samples always available for retrospective analysis and future research
- Automated redundant backup systems preserve sample stability
- 21CFR11-compliant Laboratory Information Management System that tracks samples and maintains chain-of-custody
- Flexible options for anonymizing samples to preserve confidentiality
Clinical Genotyping
- Platform-independent - we choose from a variety of platforms to deliver the best results
- Full GLP control and documentation
Drug Metabolism Enzymes (DMEs)
The FDA and other regulatory agencies require clinical trial data on defined populations of subjects for new investigational drugs, so pharmaceutical companies, clinical research organizations and site management organizations have an immediate need for genotyping services. To help clients confirm safety and efficacy, Gentris scientists use its leading Cytochrome P450 Panel - designed to capture 99% of the most important mutations that predict patient outcome - and other individual tests to categorize poor, extensive or ultra-rapid metabolizers.
Efficacy Markers
In addition to DME tests, much is known about markers that predict if a drug will be effective for a select number of therapeutic areas.
Gene Expression Assays
The scientific team at Gentris has extensive experience in mRNA profiling and qRT-PCR allowing us to design and develop quantitative and specific assays to examine gene induction or repression. Gentris offers both custom and pre-optimized quantitative RT-PCR assays for use with the ABI 7900HT managing all aspects of the project from assay design to data analysis.
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Products
Gentris is leveraging its know-how to develop GentriSure™ Human Genomic DNA Reference Controls and diagnostic test kits that can be used to make pharmacogenomic profiling accessible to physicians and patients. After obtaining FDA clearance for six controls in 2006, our 2007 goals include pursuing clearance for the rest of our product line.
Gentris currently offers controls for cytochrome P450 polymorphisms – CYP2D6, CYP2C19 and CYP2C9 - and VKORC1. Controls for other relevant polymorphisms such as UGT1A1 are under development.
GentriSure controls are isolated from B-lymphoblastoids derived from individual donors. A proprietary prescreening process was used to identify potential sources for these reference controls from a group of properly consented subjects. All sequences have been verified by bi-directional sequencing. These controls can be used for assay validation, staff training and proficiency testing, and as a quality control in routine in vitro diagnostic testing. Each vial contains 10 µL at a concentration of 50 ng/µL.
GentriSure Human Genomic DNA Reference Controls are listed at the Genetic Testing Quality Control Materials Program of the Centers for Disease Control and Prevention, (CDC) website. The polymorphisms designated were confirmed by reference testing (sequencing) and, in some cases, multi-laboratory testing.
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