Wisconsin-based PreventionGenetics LLC has earned a top global certification for its genetic testing products.
PreventionGenetics has achieved ISO 15189:2012 accreditation through the American Association for Laboratory Accreditation. The A2LA is a non-profit, independent and internationally recognized accreditation body based in the United States.
PreventionGenetics is one of few U.S.-based clinical genetic testing laboratories to have acquired the international quality assurance standard, making the company a provider of choice for international companies seeking NextGen panels, single gene tests, and deletion/duplication testing via high density gene-centric aCGH, an array-based analysis.
Formed in 2004 by Dr. James Weber, a contributor to the Human Genome Project, PreventionGenetics is one of the most comprehensive genetic testing companies in the world. A large global contender, PreventionGenetics accepts samples routinely from more than 70 countries, with comprehensive coverage for nearly 2,000 genes, in addition to exome (PGXome).
“ISO 15189:2012 provides the basis for which many health care systems and practitioners from all over the world use to select their preferred labs,” Weber said. “We have built the foundation of this company on quality standards, supported by our large, specialized PhD group. Certification confirms our lab standards for quality run as deep as our personal commitment to patient care through diagnostic expertise.”
ISO 15189:2012 defines specific quality and competency requirements particular to clinical laboratories. Certification confirms conditions within the laboratory setting are reproducible, leading to accurate results. The standard promotes global adoption of clinical practices for protection of the health and safety of patients and healthcare providers. ISO 15189:2012 also assesses the efficient exchange of information and protection of data for improved quality of care.
About Prevention Genetics
PreventionGenetics, LLC is a CLIA-accredited and ISO certified lab that offers clinical molecular diagnostic testing for near 2,000 clinically-relevant genes. We offer a rapidly growing set of NextGen panels, single gene tests, and deletion/duplication testing via our high-density gene-centric aCGH and CMA, as well as cancer testing. We also offer an affordable DNA banking service.
About ISO 15189:2012
ISO 15189 incorporates the essential elements of ISO 9001 and adds technical competency factors relevant to clinical laboratories. ISO 15189 accreditation includes both an assessment of the QMS and an evaluation of the technical competency of the laboratory, including Scope; Normative references; Terms and conditions; Management requirements; and Technical requirements.www.iso.org