Clinical Genetics at CBI's Fairfax Identity Laboratories
Fairfax Identity Laboratories, a member of the CBI group of companies, has a Clinical Genetics Division to support a wide range of Clinical Trials. Our Clinical Genetics Division is CLIA-certified and GLP compliant to assist you at any stage of your clinical trial. From pre-clinical studies to validation of your method to Phase III-IV testing, FIL can support your investigational new drug (IND) submission to the FDA and perform the genetic analysis necessary to move your product forward.
 Clinical Genetic Services
FIL supports a wide variety of clinical trials, performing services from mutation detection in blood samples to comparative microsatellite analysis of patient samples. Our clients include researchers from government, academic, and the pharmaceutical industry. FIL is CLIA certified and GLP compliant to assist in the generation of data for an investigational new drug (IND) submission to the FDA.
- Custom Assay Development
- Mutation detection by capillary electrophoresis
- Single nucleotide polymorphism (SNP) validation
- Short Tandem Repeat (STR) (microsatellite) analysis
- Quantitative (real-time) PCR analysis (qPCR)
- DNA sequencing: normal vs tumor tissue
- Mitochondrial DNA (mtDNA) sequencing and/or SNP analysis
- Genotyping by capillary electrophoresis
Any sample type is acceptable: blood, buccal swabs, urine, cerebrospinal fluid, saliva.
We also offer CLIA-certified immunoassay sample analysis and GLP vaccine lot testing services.
Assay Development and Validation
FIL can develop custom assays during the pre-clinical phase and adapt these assays for human studies. Alternatively, sponsor developed assays can be qualified and validated for use in human clinical trial testing.
Additional Clinical Trial Support
FIL offers additional services to facilitate clinical trial sample collection and testing:
- FIL will provide kits for sample collection
- FIL tracks all of its samples using an electronic LIMS database
STR Authentication of Cell lines
The NIH has recently recommended that cell lines used in research undergo authentication to verify their identity (NIH Notice Number OT-OD-08-17) and stated that "(g)rant applications that fail to employ such practices would not be considered of the highest quality and such manuscripts would not fare well in the journal review process."
Human Cell lines
FIL uses the 13 core STR loci that comprise the Combined DNA Index System (CODIS) convicted offender database to identify human-derived cell banks. These are the same loci used by ATCC to test their cell lines.
Human Herpes Virus (HHV) Testing
Fairfax Identity Laboratories (FIL) has developed a proprietary panel of DNA-based tests that can identify and quantify the eight known human herpes viruses in the blood. The panel is variant-specific and can therefore detect each subtype even in the presence of other, closely related members of the family. For more information, please visit our website at www.herpes-testing.com.
Contact:
Sarah Helber, PhD, Group Leader, Clinical Genetics
601 Biotech Dr.
Richmond, VA 23235 USA
Phone: 800-735-9224
Fax: 804-348-2641
E-mail:
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