Genelex has been a leader in molecular diagnostics and genetic testing for more than 30 years, with a specialty focus on pharmacogenetics. Our high-complexity laboratory facilities feature robotic DNA extraction and testing, proprietary test platforms and methodologies, rapid-turnaround, and test validation across multiple platforms.
Studies have shown that incorporating genetic factor results from pharmacogenetic tests into the prescribing process may help improve efficacy and reduce adverse effects. 
PGx Test Panels
Genelex currently tests for 25 genes to help understand how medications may interact with them. Tests can be ordered as a panel, or individually.
All tests include a clinical decision support tool to help identify potential drug-drug and/or drug-gene interactions.
(Includes major drug metabolizing enzymes) CYP3A4, CYP3A5, CYP2C9, CYP2C19, and CYP2D6
Polypharmacy Comprehensive Panel
ADRA2A, CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP4F2/VKORC1, COMT, DPYD, F2 (Factor II), F5 (Factor V) Leiden, GRIK4, HLA-A, HLA-B, HTR2A, HTR2C, IFNL3 (IL28B), MTHFR, NAT2, OPRM1, SLCO1B1, TPMT, UGT1A1
Note: Per the recent FDA safety communication issued October 31 2018, patients will receive patient-friendly reports that include only those genes approved by the FDA and listed in their Table of Pharmacogenomic Biomarkers. Health care providers will receive a comprehensive 25 gene report that includes a pharmacist reviewed medication management section. Healthcare providers may authorize the release of the comprehensive report to the patient. A patient may also request a copy. Patients should not alter their medication regimen unless directed to do so by a health care provider.
Reliability and Accuracy
An Experienced Lab
With more than 30 years of experience, we've pioneered a highly-complex laboratory which includes:
- Robotic DNA extraction and testing, to ensure high accuracy and low error
- Proprietary test platforms and methodologies
- Testing for more allele mutations than any other system
- Test validation across multiple platforms
- Ability to test non-invasive swab samples or blood
- Forensic-level protocols for sample accessioning
- Dedicated customer support
- Mass array
The Genelex testing laboratory is fully accredited and consistently maintains the highest standards. These standards include:
- 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
- Agena Bioscience Certified Service Provider
- Secure Laboratory Information Systems (LIS)
- Code of Federal Regulations (CFR) 21 compliant
- Health Insurance Portability and Accountability Act (HIPAA) compliant
PGx Testing Specifics
The Genelex Advantage
More than 85% of patients have significant genetic variations in the most important cytochromes  – CYP2D6, CYP2C9, CYP2C19, CYP3A4 and CYP3A5. For example, CYP3A4 and CYP3A5 affect the metabolism of one-half of the drugs in clinical use, and this variance is profoundly affected based on patient ethnicity. Additionally, Factor II Leiden (Factor 2 Leiden) and Factor V Leiden protein variations can increase the risk of dangerous cardiovascular events.
One variation example is CYP2D6. CYP2D6 acts on 25% of all prescription drugs. Approximately 7% of the population has a slow acting form of this enzyme and 7% a super-fast acting form. 35% are carriers of a non-functional CYP2D6 allele, which especially elevates the risk of ADEs when these individuals are taking multiple drugs. [6,33]