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SOURCE Gentris Corporation
Gentris Has Been Awarded Certification Based on Rigorous Quality Standards in Clinical Sample Management
MORRISVILLE, N.C., March 13, 2013 /PRNewswire/ -- Gentris® Corporation (www.gentris.com), a global leader in pharmacogenomics and biorepository solutions, announced today that its Integrated Biorepository has been accredited by the College of American Pathologists (CAP). The CAP Biorepository Accreditation Program is the first of its kind. It is a three-year, peer-based accreditation program developed to drive the adoption of standards through consistent application of best practices and evidence-based standards.
As a participant in the new Biorepository Accreditation Program, Gentris was subject to an inspection based on the CAP Accreditation checklists, an up-to-date blueprint of best practices enabling facilities to improve operations and ensure quality. Gentris is proud to participate in this new program and remains committed to maintaining the highest regulatory and quality standards.
"Every clinical biospecimen represents a patient," said Stacey O'Neill, Medical Director. "Our scientific team at Gentris is committed to preserving the integrity of these precious resources that are critical for developing new innovations in translational medicine."
CAP established this accreditation program in 2011 to help ensure consistent, industry-wide verification of biospecimen quality. The program is designed to ensure the highest standard of patient care. Currently, thousands of biorepositories exist of varying sizes, specimen types, purpose, quality standards, procedures, and age. Excellence and quality measures in biorepositories directly affect sample integrity and therefore research outcomes that can help advance health care. CAP accreditation will help these disparate facilities standardize and harmonize their standard operating procedures and improve the quality of stored samples.
"Gentris has maintained a reputation for high quality pharmacogenomics and biorepository services for over 10 years," said Rick Williams, Gentris CEO. "We are excited about participating in the launch of the Biorepository Accreditation Program as we continue building partnerships with pharma sponsors to implement the new biobanking guidelines established by the FDA."
About Gentris Corporation:
Founded in 2001, Gentris is located in Research Triangle Park, NC, where it provides pharmacogenomics and biorepository support for all phases of clinical studies and genomic biomarker programs. The Company works with academic and industry leaders to translate innovations in pharmacogenomics into safer, more effective medicines, which can lead to accelerated drug development and improvement in patient care globally. In the past year, Gentris significantly expanded its facility and onsite biorepository to meet the increased needs of biopharma clients, while maintaining a preeminent quality system.
About Stacey O'Neill, M.D., Ph.D.
Dr. Stacey O'Neill has joined Gentris as Medical Director in 2012. Dr. O'Neill oversees the clinical operations and regulatory compliance, evaluates the clinical utility and interprets results from pharmacogenomics assays, and participates in scientific education and training programs. Dr. O'Neill completed a Molecular Genetic Pathology Fellowship and Anatomic and Clinical Pathology Residency from The University of North Carolina at Chapel Hill. Dr. O'Neill received her M.D. and Ph.D. from the University of Virginia, where she studied the relationship between routes of immunization, homing capacities of activated T cells, and the development of memory to enable the design of more effective dendritic cell-based cancer vaccines. She received her Bachelor of Science degree in Biochemistry from the University of Delaware.
About the College of American Pathologists
The College of American Pathologists (CAP) is a medical society that serves more than 17,000 physician members and the laboratory community throughout the world. It is the world's largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high quality and cost effective medical care.
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