Risk interpretation based on Coriell’s SLCO1B1/Simvastatin Response Genotype Translation Version 1 (November 2013).
Interpretation
This individual is expected to have
Intermediate liver uptake activity
based on the Combined Genetic Result:
SLCO1B1*1/*3
Individuals with intermediate SLCO1B1 liver uptake activity have a moderately increased risk of myopathy when taking a 40 mg/day or higher dose of simvastatin. A reduced dosage or alternate statin drug should be considered.
Test Limitations
DNA-based testing is highly accurate, however there are many sources of potential error including: mis-identification of samples, rare technical errors, trace contamination of PCR reactions, and rare genetic variants that interfere with analysis. There may be other variants in the SLCO1B1 gene that are not included in this test, that influence the response to simvastatin (Zocor®). This test or one or more of its components was developed and its performance characteristics determined by the Coriell Institute for Medical Research. It has not been approved by the Food and Drug Administration (FDA). The FDA has determined that such approval is not necessary. The Coriell Institute is regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 as qualified to perform high-complexity testing.
Test Methodology
Saliva samples were collected using Oragene DNA Collection Kits (DNA Genotek) and DNA was extracted manually according to the manufacturer’s instructions or automatically using a DNAdvance Kit (Agencourt). Purified DNA was quantified using UV absorbance at 260 nm. One microgram of the resulting DNA from each sample was used as template in the Affymetrix DMET Plus GeneChip assay. Data analysis was performed using Affymetrix DMET Console software.