Pipeline

Future Growth: A Pipeline of Medically Necessary Tests

CardioIDgenetix

CARDIOVASCULAR

The IDgenetix cardiovascular tests provide PGx-based treatment guidance on the most highly prescribed drug classes used in cardiology, including anti-platelet, anti-coagulant, statins, beta-blockers, ACE inhibitors, calcium channel blockers and hormone therapies.

Ten cardiology drugs are included on the FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling as having PGx information in the drug labeling. For example, clopidogrel, one of the most commonly prescribed anticoagulants, has an FDA black box warning and additional label information for poor and intermediate CYP2C19 metabolizers.

For additional Information:

CPIC Guidelines for CYP2C9 and VKORC1 genotypes and warfarin dosing.
http://www.ncbi.nlm.nih.gov/pubmed/21900891

CPIC guidelines for CYP2C19 genotype and clopidogrel therapy: 2013 update
http://www.ncbi.nlm.nih.gov/pubmed/23698643

FDA Table of Pharmacogenetic Biomarkers in Drug Labeling
http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm

NeuroIDgenetix

PAIN MANAGEMENT

The IDgenetix pain tests analyze the genes and genetic mutations involved in the metabolism of opioids, non-steroidal anti-inflammatory drugs, and other pain drugs as well as variations in pharmacodynamic genes, such as the μ opioid receptor gene, or OPRM1. For example, the CYP2D6 enzyme, which is analyzed by IDgenetix tests, governs the metabolic conversion of codeine to morphine in the body, which is what gives the patient pain relief. Genetic variation in CYP2D6 impacts the safety and efficacy of codeine because patients that are ultra-rapid metabolizers convert codeine into an unsafe dose of morphine. As a result, CPIC has issued guidelines for codeine, and codeine has an FDA black box warning and additional label information for ultra-rapid CYP2D6 metabolizers.

For additional Information:

CPIC Dosing Guideline for codeine and CYP2D6
https://www.pharmgkb.org/guideline/PA166104996

FDA Table of Pharmacogenetic Biomarkers in Drug Labeling
http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm

Thrombophilia

THROMBOPHILIA

The thrombophilia panel analyzes gene mutations (Factor V Leiden, Prothrombin G20210A) associated with an increased risk of developing venous thromboembolism and mutations in the MTHFR gene associated with an increased risk for hyperhomocysteinemia.

References:

1) Ingelman-Sundberg M, Sim S, Gomez A, Rodriguez-Antona C. Influence of cytochrome P450 polymorphisms on drug therapies: Pharmacogenetic, pharmacoepigenetic and clinical aspects. Pharmacology & Therapeutics. 2007;116: 496–526.

2) Ingelman-Sundberg M, Rodriguez-Antona C. Pharmacogenetics of drug-metabolizing enzymes: implications for a safer and more effective drug therapy. Philos Trans R Soc Lond B Biol Sci. 2005;360:1563-1570.

3) Fanikos J, Grasso-Correnti N, Shah R, Kucher N, Goldhaber SZ. Major bleeding complications in a specialized anticoagulation service. Am J Cardiol. 2005;Aug 15;96(4):595-598.

4) Machado M, Iskedjian M, Ruiz I, Einarson TR. Remission, dropouts, and adverse drug reaction rates in major depressive disorder: a meta-analysis of head-to-head trials. Curr Med Res Opin. 2006;Sept. 22(9), 1825-1837.

These test panels have not been reviewed or approved by the US Food and Drug Administration. They are Laboratory Developed Tests (LDTs) developed by AltheaDx and run exclusively in our CLIA-certified lab.