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Genelex has been a leader in providing quality DNA testing since our inception in 1987. Accreditation and quality assurance programs we participate in include: Genelex has been accredited by the AABB Parentage Testing Committee in DNA parentage testing since 1992. Click here to view a copy of our current AABB accreditation. Genelex is a CLIA licensed medical laboratory - Washington State Medical Test Site No. MTS-3919 CLIA No. 50D0980559. Click here to view a copy of our current CLIA accreditation. Genelex is an accredited clinical laboratory for parentage and identity testing for the New York State Department of Health. Click here to view a copy of our current NYSDOH accreditation. Genelex has participated in the College of American Pathologists Anatomical Pathology Education Programs and voluntary quality assurance program for over a decade. Click here to view a copy of our current CAP certification.
Genelex has also contributed to the validation of National Institute of Standards and Technology (NIST) Standard Reference Materials. Regulation of Genetic Tests Genetic tests performed at Genelex are Laboratory Developed Genetic Tests (LDTs). These tests are not under the FDA regulation policy although the analyticsl specific reagents (ASRs) are independently regulated by the FDA. Laboratory Developed Genetic Tests are regulated by Clinical Laboratory Ammendment Act (CLIA). Genelex is a CLIA certified laboratory.
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3000 First Ave., Suite One, Seattle, WA 98121 800 523-3080 |
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