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Company Profile

Gene Express Inc

Pages 793-796 | Published online: 03 Aug 2006

Bibliography

  • US Department of Health and Human Services. Medicare, Medicaid and CLIA programs: Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Fed. Regist.57, 7002–7186 (1992).
  • Chen B , O' Connell CD, Boone DJ et al.: Developing a sustainable process to provide quality control materials for genetic testing. Genet. Med.7, 534–549 (2005).
  • Gilliland G , PerrinS, BlanchardK, Bunn HF: Analysis of cytokine mRNA and DNA: detection and quantitation by competitive polymerase chain reaction. Proc. Natl Acad. Sci. USA87, 2725–2729 (1990).
  • Willey JC , CrawfordEL, KnightCR et al.: Standardized RT-PCR and the standardized expression measurement center. Methods Mol. Biol.258, 13–41 (2004).
  • Willey JC : Quality-controlled multigene expression management: an essential tool for discovery of drugs and diagnostic tests.PharmaGenomics,20–33 January (2004).

Websites

  • Guidance for Industry and US FDA Staff Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System, March 10 (2005). www.fda.gov/cdrh/oivd/guidance/1551.html#7
  • Guidance for Industry and US FDA Staff Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems, March 10 (2005). www.fda.gov/cdrh/oivd/guidance/1546.html
  • Gene Express Inc. www.geneexpressinc.com
  • US FDA Micro-Array Quality Control Project. http://edkb.fda.gov/MAQC/

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