Gentris Corporation has announced the availability of Human Genomic DNA Reference Controls for the Cytochrome P450 2D6 gene (CYP2D6).
CYP2D6 affects the metabolism of a large number of compounds, including several commonly prescribed cardiovascular, anti-depressant and analgesic drugs.
According to the FDA’s Center for Drug Evaluation and Research, approximately seven percent of the U.S. population carries genetic variations that lead to reduced levels of activity of CYP2D6.
These variations could result in severe adverse reactions to drugs metabolized by CYP2D6 if not identified before administration with routine tests.
"Reference controls can be viewed as being as important as the very tests themselves," said Michael Murphy, Gentris President and CEO.
"Without proper controls, test results cannot be validated and are therefore inconclusive. Until now, having access to a consistent, reliable source of reference controls has been a challenge for laboratories developing or performing CYP2D6 assays."
"Gentris is proud to be the first to offer a selection of the important reference controls for CYP2D6."
Gentris’ CYP2D6 reference controls were developed using a proprietary process. Up to this point, laboratories have been using leftover human specimens, a practice which could lead to serious quality and informed consent issues.
By using reference controls from Gentris research laboratories can access a continuous supply of consistent, properly consented genomic material.
The composition of these controls has been verified by bi-directional sequencing, the gold standard of DNA characterization.
The controls are designed for use with a variety of testing platforms being used in research laboratories.
Genomic controls do not require the introduction of artificial DNA sequences into the cell lines, therefore these controls most closely mimic the behavior of genomic DNA isolated from human samples.
The Gentris CYP2D6 Human Genomic DNA Reference Controls are available for research use only at this time.
Gentris intends to offer reference controls for additional genes in the future including CYP2C9, CYP2C19 and UGT1A1.