In-depth guides
Regulatory & compliance
Is PGx Interpretation Software FDA-Cleared? Vendor vs. Lab Liability
Why most PGx interpretation software isn't FDA-cleared by design, the 2026 LDT reset, and who is liable when an interpretation is wrong.
Vendor migration
Translational Software Alternative: What to Look for in a Replacement
After the PGxPortal discontinuation, the 5 capabilities to audit in a replacement PGx reporting layer, and how to plan the migration.
PGx how-to
How to Convert VCF Files into Clinical PGx Reports
Turn already-called VCF, PharmCAT, or Agena genotypes into a clinician-ready, lab-branded PGx report.
PGx how-to
How to Automate CPIC Guideline Updates & Prevent PGx Version Drift
Replace manual CPIC/FDA/DPWG reconciliation with an automated evidence layer and living reanalysis.
For small labs
PGx Software for a Small, Independent CLIA Lab
Launch PGx reporting in-house without hiring a geneticist — your director reviews and signs out drafts from CPIC, FDA and DPWG.
Buyer's guide
How to Evaluate PGx Reporting Software (+ RFP Template)
A 7-step evaluation framework, a MolDX readiness checklist, and a reusable RFP template for shortlisting PGx vendors.
Oncology PGx
Automate DPYD Reports for 5-FU & Capecitabine
Turn called DPYD genotypes into director-ready reports that match CPIC and the FDA's fluoropyrimidine safety labeling.
Reimbursement
PGx Billing: CPT Codes, Z-Codes & Payer Approval
The CPT codes, MolDX Z-code, and CPIC evidence payers look for — and how report structure supports a clean claim.
Validation
How to Validate a PGx Assay Under CLIA
A lab director's checklist: the 7 analytical characteristics, concordance testing, CAP requirements, and proficiency testing.
Specialty panels
Build Specialty PGx Panels: Psych, Pain & Cardiology
Select CPIC Level A genes for psychiatry, pain, and cardiology panels you run under your own sign-out — build vs. license.
PGx science
Phenoconversion: When Genotype-Predicted Phenotype Misleads
Why a genotypic normal metabolizer can behave like a poor one — and how reports should standardize phenotype and flag drug-drug-gene interactions.
PGx basics
What Is a Pharmacogenomic (PGx) Report?
A plain-language guide to the anatomy of a PGx report: genotype, phenotype, drug guidance, evidence sources, limitations, and sign-out.
Integration
Integrating PGx Reports With Your LIS and EHR
How a reporting layer connects to Epic Beaker, Oracle Health (Cerner), Sunquest and Orchard via HL7, FHIR, SMART on FHIR and CDS Hooks.
Global PGx
International PGx Reporting: EMA, Health Canada, DPWG
Aligning reports with EMA, Health Canada, Swissmedic, PMDA and DPWG guidance for labs serving non-US or multinational markets.
Security
Is PGx Software HIPAA Compliant? Security & SOC 2
What to require of a PGx vendor: BAAs, encryption, RBAC, tenant isolation, audit trails, and how to ask about SOC 2 and ISO 27001.
Drug-gene: cardiology
CYP2C19 & Clopidogrel: Antiplatelet PGx Reporting
How labs turn a called CYP2C19 diplotype into a clopidogrel report — phenotype, CPIC-guided alternatives, and director sign-out.
Drug-gene: GI & heme
TPMT & NUDT15: Thiopurine Dosing-Risk Reporting
Combine TPMT and NUDT15 genotypes into a thiopurine myelosuppression-risk report per CPIC.
Drug-gene: cardiology
SLCO1B1 & Statins: Myopathy-Risk PGx Reporting
Report SLCO1B1 transporter function and statin-associated myopathy risk per CPIC.
Drug-gene: anticoagulation
CYP2C9, VKORC1 & Warfarin: Genotype-Guided Dosing
Assemble a warfarin PGx report presenting CYP2C9/VKORC1 genotype-guided dosing context per CPIC and the FDA table.
Drug-gene: HLA
HLA-B: Abacavir & Carbamazepine Hypersensitivity
Report HLA-B*57:01 (abacavir) and HLA-B*15:02 (carbamazepine) risk-allele results for director review.
Drug-gene: multi-drug
CYP2D6: Codeine, Tamoxifen & Antidepressant Reporting
The activity-score phenotype and CPIC/FDA guidance across opioids, tamoxifen, and antidepressants.
Drug-gene: oncology
UGT1A1 & Irinotecan: Toxicity-Risk Reporting
Report UGT1A1*28 status and irinotecan neutropenia/diarrhea risk context for director review.
Drug-gene: transplant
CYP3A5 & Tacrolimus: Transplant Dosing Reporting
Report CYP3A5 expresser vs non-expresser status and tacrolimus starting-dose context per CPIC.
Drug-gene: HIV
CYP2B6 & Efavirenz: HIV Pharmacogenomic Reporting
Report CYP2B6 phenotype and efavirenz exposure and CNS-risk context per CPIC.
Drug-gene: hematology
G6PD Deficiency: Oxidative-Drug Risk Reporting
Report G6PD status and rasburicase/oxidative-drug hemolysis risk — with the genotype-vs-activity caveat.
Latest updates
Loading insights…