What Makes a Good Lab?
DNA test results have been a clinical tool for years now. However, just like any industry, unlawful or ineffective labs can sometimes hide behind the veneer of legitimacy. Vetting a laboratory before testing with them is important.
Here’s what to look for in a DNA testing laboratory:
- CLIA certification. Clinical Laboratory Improvement Amendments (CLIA) are federal regulatory standards for all clinical labs that do human testing except clinical trials and basic research.
- CAP accreditation. Accreditation from the College of American Pathologists is the gold standard and means that the lab practices good quality management, laboratory safety, document control, director oversight, etc. Do not test with labs without CAP accreditation.
- New York State Certification. New York has especially stringent quality and privacy requirements for laboratories. Only laboratories that have been accredited by the New York State Department of Health (NYSDOH) can do genetic testing in New York.
- Genes and Alleles. Laboratories should test for all relevant alleles – genetic variants – with a high (>99%) specificity. This includes genetic duplications and deletions, which many labs miss and can result in false results.
- Office of Inspector General (OIG) Audited. Passing an audit by the OIG means that the U.S. Department of Labor has approved of the labs effectiveness, efficiency, economy and integrity.
- Automated Equipment. Automated equipment and computerized laboratory information systems from accessioning to reporting limit the chance of errors associated with manual sample handling and data entry.
- Qualified Scientific Advisory Board. Scientific advisory boards help the laboratory research and validate their testing processes. Members should be highly qualified.
If you’re talking with a DNA testing company, here are some good questions to ask:
- How many tests do they offer?
- How quickly are the results available?
- How are the results reported? How useful are they in helping you improve care?
- Is there a tool available to help you interpret the results? What if you have questions about the implications of your results?
- Does the company have pharmacist/customer support?
- How do they ensure testing accuracy?
- Does the company have a research or scientific advisory board? How do they evaluate the evidence base and clinical actionability of their tests?
- How long has the company been testing? What are their plans for the future?
- Do they have affiliations with other organizations?
- What HIPAA protections do they have in place?
- Do they know about the Stark Law and its Anti-Kickback Statute?
- Do they market directly to patients? Patient-provider communication is vital to accurately interpreting results and making the most appropriate decisions.
Picking correctly can help ensure accuracy, speedy results and legal protection for both you and your patients.
Take a Risk Assessment
Simply enter the medications you’re currently on or plan to take. Click “Get Results” to see if your regimen puts you at risk for an adverse drug reaction.
YOUR GENELEX RISK ASSESSMENT RESULTS: