What does CPIC provide that FDA's table does not?

CPIC publishes detailed, graded clinical practice guidelines with specific dosing recommendations for genotype-phenotype combinations, intended to help clinicians act on PGx results, complementing FDA's evidence summary table.

Are pharmacogenomic laboratory-developed tests regulated the same way as cleared IVDs?

Historically, most PGx laboratory-developed tests have been offered under CLIA regulation of the performing laboratory rather than FDA premarket device review, though the appropriate scope of FDA oversight of LDTs has been the subject of ongoing rulemaking and litigation.

All terms

Clinical & TrialsClinical EvidencePGx

Pharmacogenomics

The study of how genetic variation affects an individual's response to drugs, used to guide dosing, drug selection, and companion diagnostic development.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

Definition

Pharmacogenomics (PGx) is the study of how variation in genes, particularly those encoding drug-metabolizing enzymes, transporters, and drug targets, affects an individual patient's efficacy or risk of adverse reaction to a medication. FDA maintains a publicly available Table of Pharmacogenetic Associations that summarizes gene-drug pairs with evidence supporting an association between a genetic variant and altered drug metabolism, response, or risk of an adverse reaction, categorized by the strength of supporting scientific evidence. The Clinical Pharmacogenetics Implementation Consortium (CPIC) publishes peer-reviewed, evidence-graded clinical practice guidelines that translate PGx test results, such as CYP2C19 or CYP2D6 genotype, into actionable prescribing recommendations for specific drugs. PGx testing intersects directly with companion diagnostics when a test result is used to identify patients likely to benefit from, or be harmed by, a specific therapy named in the drug's labeling.

What the regulation says

FDA states that its Table of Pharmacogenetic Associations reflects the agency's assessment of the scientific evidence available for gene-drug interactions, but inclusion in the table does not itself constitute a labeling requirement, and prescribers should consult the approved drug labeling for specific dosing guidance.

What this means in practice

PGx is increasingly incorporated into drug labeling sections on dosage and administration, warnings, and clinical pharmacology, and FDA's Table of Pharmacogenetic Associations is distinct from, but complementary to, the FDA list of cleared or approved companion diagnostic devices. Laboratories offering PGx panels as laboratory-developed tests have historically operated under CLIA rather than FDA device clearance, a distinction under active regulatory discussion following FDA's LDT final rule and subsequent legal developments.

Common pitfalls

•Assuming inclusion of a gene-drug pair in FDA's PGx table means the interaction is described in the approved drug label; the table includes associations with varying levels of evidence, some not yet reflected in labeling.
•Treating a laboratory-developed PGx panel as equivalent in regulatory status to an FDA-cleared or approved companion diagnostic when it has not gone through the same premarket review.
•Applying CPIC dosing guidance without confirming it matches the specific drug label and patient population under FDA's current labeling for that product.

Frequently asked questions

FDA's Table of Pharmacogenetic Associations catalogs gene-drug pairs supported by varying levels of scientific evidence for informational purposes, whereas a companion diagnostic is a specific, cleared or approved IVD device required by a drug's label to identify eligible patients.

Grouped by theme

Editor's picks

· Hand-selected related concepts

Market Segments

Companion Diagnostic(CDx)

IVD that identifies patients who will benefit from a specific drug.

Regulatory

Companion Diagnostic (IVDR)(CDx)

IVD that is essential for the safe and effective use of a corresponding medicinal product to identify eligible patients or monitor treatment response.

Market Segments

Laboratory-Developed Test(LDT)

IVD designed, manufactured, and used within a single CLIA laboratory.

Reimbursement

RWE for Reimbursement

Real-world evidence used to support coverage and payment decisions.

Sources

3 sources

Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

Tier 2Regulator guidance and consensus· 2Tier 4Trade press and expert commentary· 1

Link health: 3 unchecked· last checked 2026-06-20

FDA·2CPIC·1

Inline markers like [1] jump to the matching reference above.