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Expression Analysis Hires Senior Director of Quality Systems.


DURHAM, N.C. -- Expression Analysis, Inc., a leading global provider of genomic services for clinical trials, including Affymetrix GeneChip[R] , Illumina BeadArray[R], Luminex xMAP[R] and Applied Biosystems' TaqMan[R] technologies, has hired C. Anne Pontius to be Senior Director of Quality Systems. Ms. Pontius will be responsible for regulatory compliance and QA activities in the company's testing facility, which currently adheres to applicable laws and guidances in Good Laboratory Practices (GLP See gateway location protocol. ) 21 CFR CFR

See: Cost and Freight
 58 and Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.  of 1988 (CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a ).

"Expression Analysis has a reputation for leadership and high quality genomic services," said Ms. Pontius. "Expression Analysis was the first genomic testing provider to offer GLP-compliant microarray services and pioneered a now established, proficiency testing program for Affymetrix testing providers. I look forward to building onto our strong quality foundation to create the industry's first genomic testing provider with a fully implemented Quality System as defined by ISO (1) See ISO speed.

(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI.
 and CLSI CLSI Clinical and Laboratory Standards Institute (Wayne, PA)
CLSI Cisco Link Services Interface
."

Ms. Pontius holds a Masters in Business Administration, a Bachelors of Science in Medical Technology, and is certified by the American College American College is the name of:
  • American College Dublin, Dublin, Ireland
  • The American College in Madurai, Tamil Nadu, India
  • The American College of the Immaculate Conception, Leuven (also known as Louvain), Belgium
 of Medical Practice Executives. Most recently, she was President & Principal Consultant for Laboratory Compliance Consultants, Inc., a national consulting firm specializing in regulatory compliance, financial feasibility and operational issues for clinical laboratories. Ms. Pontius is a nationally recognized speaker and has authored more than one hundred publications. She is currently the President Elect of the Clinical Laboratory Management Association.

"We are delighted to have Anne join our management team," said Steve McPhail, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  and President of Expression Analysis. "Her CLIA experience and clinical perspective will add tremendous benefit to our organization as we enhance our infrastructure to move genomic technologies from clinical development to clinical practice. Anne will enable us to meet this goal, which is particularly important as many of our clients develop diagnostic applications from their genomic research test results."

About Expression Analysis, Inc.

Expression Analysis, Inc. (http://www.expressionanalysis.com) is the industry's leading provider of microarray-based genomic services for clinical trials. Specializing in gene expression and genotyping assays on Affymetrix GeneChip[R] microarrays, the company also provides complementary services using Illumina BeadArray[R], Luminex xMAP[R] and Applied Biosystems' TaqMan[R] technologies.
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Publication:Business Wire
Date:Jul 2, 2007
Words:362
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