Table 2.
Summary of the Coriell Personalized Medicine Collaborative drug-gene pharmacogenomics reports evaluated by the Pharmacogenomics Advisory Group
Drug and gene pair(s) | Approval status | Reason for rejection/deferral | Highly actionable genetic results a |
---|---|---|---|
Warfarin and
VKORC1
,
CYP2C9
,
CYP4F2
, or
GGCX
|
All except GGCX approved |
Insufficient clinical support for GGCX at time of submission evaluation |
Low warfarin dose requirementb |
Clopidogrel and
CYP2C19
|
Approved |
NA |
Poor metabolizers |
Tamoxifen and
CYP2D6
|
Deferred |
The data linking prognostic and predictive relevance of CYP2D6 variants to guide tamoxifen therapy for breast cancer was inconclusive. Vote has been deferred pending publication of anticipated clinical trials data |
Vote deferred |
Codeine and
CYP2D6
|
Approved |
NA |
Ultra-rapid metabolizers |
Metoprolol and
CYP2D6
|
Rejected |
Lack of clinical evidence, and given prescribing practices, the genetic results are unlikely to influence drug dose adjustment |
NA |
Thiopurines and
TPMT
|
Approved |
NA |
Intermediate and poor metabolizers |
PPIs and
CYP2C19
|
Approved |
NA |
None |
Diazepam and
CYP2C19
|
Rejected |
Evidence for clinical consequences is weak |
NA |
Statins and
CYP3A4/CYP3A5
,
SLCO1B1
,
LDLR
, or
HMGCR
|
Simvastatin and SLCO1B1: approved, CYP3A4/CYP3A5: deferred. LDLR and HMGCR: rejected |
LDLR and HMGCR: evidence for clinical utility is lacking |
Simvastatin and SLCO1B1: genetic results associated with decreased hepatic drug uptake |
Celecoxib and
CYP2C9
|
Approved |
NA |
*3/*3 |
Fluorouracil and DPYD | Rejected | Combination of recent evidence for lower penetrance of reduced activity variants, and a lack of good alternative treatment reduces the clinical utility of the PGx information | NA |
Abbreviations: NA not applicable.
aGenetic results that warrant additional communication to participants who are at increased risk, and who have not viewed their risk report.
b‘Low dose’ is defined as a daily therapeutic dose of 0.5 to 2 mg based on the FDA drug label genotype guidelines table.