Quest Diagnostics announced that the specimen biorepository of its Quest Diagnostics Clinical Trials business, a leader in laboratory testing services to advance drug discovery and development, has been accredited by the College of American Pathologists (CAP), the international laboratory accrediting organization.
Based at the Quest Diagnostics clinical laboratory in Valencia, Calif., the biorepository maintains de-identified tissue, blood and urine specimens, including molecular and genetic material, collected from the United States and internationally for use primarily by pharmaceutical and biotechnology companies in clinical trials to research and develop new drug treatments.
The CAP program is the first-of-its-kind peer-based accreditation program developed to improve and standardize quality and consistency in collecting, processing, storing, distributing, and computerizing information for biospecimens while ensuring the quality of human specimens and genetic material. Accreditation requires passing CAP inspections of procedures for patient consent and collection of biospecimens, their processing and annotation, and their storage, transport, and distribution. The voluntary program started in 2011.
"Although biospecimens are increasingly used in new drug and companion diagnostic development, a lack of standards to promote quality can jeopardize the reliability of data generated through clinical trials," said Christopher C. Fikry M.D, vice president, Quest Diagnostics Clinical Trials. "Maintaining the integrity of specimens for molecular and genetic research is particularly important given the fragility of these materials. Our participation in CAP's accreditation program demonstrates our commitment to help our clinical trial and academic collaborators generate the quality research needed to drive medical discovery and innovation, particularly for personalized therapies based on genetic or molecular factors."
Quest Diagnostics Clinical Trials provides biorepository specimen storage and processing services internationally as part of a larger offering of services that includes biomarker development and anatomic pathology. With central laboratory facilities in North America and Europe, and alliance laboratories in China, Australia, and South America, Quest Diagnostics Clinical Trials supports investigative sites in over 4,000 cities across 80 countries. The Quest Diagnostics Clinical Trials business may provide specimens maintained by the Quest Diagnostics biorepository for clinical trials research pursuant to FDA guidelines.