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For Clinical Trials

Accurate. Consistent. Rigorous.

Genelex has been providing genotyping services for clinical trials and research studies since 2000. A recognized leader in DNA testing and analysis, Genelex offers unrivaled depth of experience to pharmaceutical companies and contract research organizations (CROs).

The advantages of working with Genelex include:

  • Dedicated customer support
  • Rapid 2-day turnaround available
  • Customizable assay design and development
  • Test validation across multiple platforms
  • Ability to test non-invasive buccal samples or blood
  • Forensic-level protocols for sample accessioning
  • Robotic DNA extraction and testing, to ensure high accuracy and low error
  • Capacity to test for more allele mutations than any other system

Genelex maintains a fully accredited, high-complexity DNA testing laboratory:

  • College of American Pathologists (CAP) accreditation; 100% pass rate on CAP efficiency tests
  • Clinical Laboratory Improvement Amendments (CLIA) certification; licensed to perform testing in all U.S. states
  • State of New York Department of Health-accredited clinical laboratory for molecular genetic testing
  • International Reference Laboratory accreditation
  • Secure Laboratory Information Systems (LIS)
  • Compliant with Code of Federal Regulations (CFR) 21
  • Health Insurance Portability and Accountability Act (HIPAA) compliant

Genelex currently offers the following pharmacogenetic tests for research or clinical trials:

Here is what a Quality Assurance Director had to say about his visit to Genelex:

“Everyone was very helpful, knowledgeable, and open with all of my requests. The facility is neat and orderly and designed to prevent cross-contamination of samples (e.g., segregation during various sample preparation steps for PCR amplification). The validation of the new technology was well planned and executed. All of the requirements that I like to see were performed:

  • On-site training of all personnel by the Tag-it Kit manufacturer
  • Parallel testing with an independent laboratory
  • Testing of samples that challenge the system (Corriel Samples)
  • Testing of normals (in-house blood draws)
  • Duplicate testing of samples for correlation
  • Development of positive controls for future testing (select Corriel Samples)
  • Establishment of Proficiency Testing

All study and validation data correlated nicely and demonstrated an accurate, robust assay with a well-defined method of data interpretation.”

For more information or to request a quote, please contact Genelex at info@genelex.jp

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