Frequently Asked Questions

The DecisionDx-UM test is the most accurate prognostic test for uveal melanoma available. Data from an independent, prospective study of 494 patients conducted by the Collaborative Ocular Oncology Group (COOG) showed that the GEP test (DecisionDx-UM) could successfully classify tumors more than 97 percent of the time. There are now more than 20 published studies supporting use of the DecisionDx-UM test.

Having an accurate understanding of the risk of your cancer metastasizing (spreading) is a critical part of determining the right approach to your treatment and ongoing management of SCC. Similar to other cancers, treatment plans for SCC are based upon the likelihood that your tumor may spread or metastasize. Traditionally, this was estimated using only the presence or absence of risk factors. Traditional factors that indicate your tumor may be at a higher risk include: tumors that are large in size or appear in specific locations (i.e., ear, lip and temple); tumors that look “poorly differentiated” (disorganized) under the microscope; tumors that approach and invade nerves (perineural involvement); tumors that are found to be deep; during surgery, you have immunosuppression; tumors that are growing rapidly.

The goal of the TissueCypher test is to predict your personalized risk of progressing to high-grade dysplasia or esophageal cancer. Knowing this potential risk helps your physician gauge how aggressively to treat your Barrett’s esophagus. Your TissueCypher test result includes a risk score and a five-year probability of progression to high-grade dysplasia or esophageal cancer. For example, a risk score of 8.0 has an associated five-year probability of progression of 27%. This means that during the clinical validation studies, 27% of patients with a risk score of 8.0 progressed to high-grade dysplasia or esophageal cancer within five years. Knowing your personalized risk enables your physician to make risk-aligned adjustments to your care plan.

TissueCypher has been in clinical use since 2016 and has been validated in five clinical validation studies using one of the largest sets of BE progressors ever assembled.

Many psychiatric drugs are metabolized by the CYP enzymes, including 2D6, 2C19 and 2C9, which are genes included in our IDgenetix® tests. The CYP2D6 enzyme, for example, primarily or substantially metabolizes a number of selective serotonin reuptake inhibitors, or SSRI, serotonin-norepinephrine reuptake inhibitors, or SNRI, and tricyclic antidepressants or TCA, which are, according to IMS Health, the three most-commonly prescribed drug classes in psychiatry, as well as antipsychotic drugs. Our neuropsychiatric tests also include variant analysis for informative receptor and transporter genes associated with clinical response to psychiatric drugs and risk of side effects, such as SLC6A4 and HTR2A, which are important factors for psychiatric drugs. More than 10% of patients taking antidepressants experience significant adverse drug reactions. Twenty-four psychiatry drugs are included on the FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling as having PGx information in the drug labeling. For additional Information: Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants.

Link to Publication

FDA Table of Pharmacogenetic Biomarkers in Drug Labeling

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.

We have our own educational channel on YouTube called IDgenetix® TV with tons of relevant educational Pharmacogenomics (PGx) pearls that you can listen on at own time. Our MSL who is an expert in PGx can speak with you on an individual basis regarding any questions you may have or review your patient’s IDgenetix report with you. For ease and efficiency, please use the Calendly link to set up a personalized session with our MSL, Behnaz Sarrami, MS, PharmD.

Based on the largest depression study conducted, funded at 35 million US dollars, the STAR*D Trial showed that about half the patients do not respond on the first round of treatment for depression. Using IDgenetix® as a tool to help guide therapy rather than the traditional trial-and-error mental health prescribing is key in getting patients mentally stable sooner.

Depression and Anxiety Individual patient response to medications is influenced by genetic variation in the enzymes responsible for drug metabolism as well as targeted receptors and transporters. The family of cytochrome P450 genes code for enzymes responsible for approximately 80% of phase 1 drug metabolism. Genetic variation of these genes alone is estimated to influence 20-25% of all drug therapies to the extent that outcome is affected. [1] Why is this important? Variations in metabolism can cause life-threatening toxicity in one patient and reduce drug effectiveness in another.[2] Clinically significant genetic alterations in the cytochrome P450 (CYP) genes can result in decreased or increased enzyme activity. These alterations in enzyme function are categorized into four phenotypes. Knowing a patient’s metabolic phenotype and its impact on drug metabolism can empower clinical treatment decisions, increase drug efficacy, and reduce the risk of adverse events. Extensive Metabolizers (EM) carry 2 functional genes and have normal enzyme activity. Standard medication dosing is appropriate for extensive metabolizers. Poor Metabolizers (PM) have severely reduced or no functional capacity to metabolize substrate medications. Poor metabolizers are at risk for side effects due to toxic drug accumulation and may require lower doses. Intermediate Metabolizers (IM) also have a severely reduced capacity to metabolize drugs and therefore may also require modified drug doses. In contrast, Ultra-Rapid Metabolizers (UM) typically carry multiple copies of the same gene and have elevated enzyme activity and may need increased drug dosing or decreased drug dosing, in the case of pro-drugs, in order to offset the higher rate of metabolism.

Based on our pharmaco-economical RCT, the direct and indirect cost of depression is about $30,000 annually per patient. Indirect costs such as loss of job and suicide takes a huge toll on not just the patients but the patient’s families and the healthcare system. IDgenetix® has shown to save each patient about $6,000 per year by personalizing patient’s medications based on their genetic makeup.

Each person has two alleles that are inherited from each parent. Alleles are variations of a gene that determine our phenotype.