GeneSight® is a test marketed in the US by a company called Assurex Health, Inc. Really it should be called a test battery or test panel since it consists of testing for multiple genes. They call their approach “combinatorial pharmacogenomic (CPGx™)” to indicate that they are making recommendations based on the combination of findings on the tests.
There are four test batteries offered, but you will notice that many of the genes are covered in more than one test battery. A total of 16 genes are evaluated, both pharmacokinetic and pharmacodynamic.
Pharmacokinetic genes: Cytochrome P450 1A2, 2B6, 2C9, 2C19, 2D6, 3A4, UGT1A4, UGT2B15
pharmacodynamic genes: SLC6A4, HTR2A, OPRM1, COMT, ADRA2A
(Note: The GeneSight® assay does not test for the rs25531 polymorphism that subdivides the L form of the serotonin transporter promoter into L(A) and L(G) forms (see Serotonin transporter linked polymorphic region (5-HTTLPR)
Other: MTHFR, HLA-B*1502, HLA-A*3101
Test panels offered
1. GeneSight Psychotropic
Pharmacokinetic genes: Cytochrome P450 1A2, 2B6, 2C9, 2C19, 2D6, 3A4, UGT1A4, UGT2B15
Pharmacodynamic genes: SLC6A4, HTR2A
Other: HLA-B*1502, HLA-A*3101
2. GeneSight Analgesic
Pharmacokinetic genes: Cytochrome P450 2D6 (CYP2D6), 2C19 (CYP2C19), 2C9 (CYP2C9), 3A4 (CYP3A4), 2B6 (CYP2B6), 1A2 (CYP1A2)
Pharmacodynamic gene: OPRM1.
3. GeneSight ADHD
Pharmacokinetic Gene Cytochrome P450 2D6 (CYP2D6)
Pharmacodynamic Genes COMT and ADRA2A.
4. GeneSight MTHFR
Background
The GeneSight test is provided by the Assurex Health clinical laboratory. It is based on patented technology that Assurex has licensed from the Mayo Clinic and from the Cincinnati Children’s Hospital Medical Center.
As of May 2017, over 39,000 healthcare providers have registered to use the test and over 500,000 patients have undergone testing.
Process
For each patient tested, the company offers free consultation with their Medical Affairs team that can be done either over the phone or in person.
Payment
Many commercial plans pay something for the test, but I don’t know how much they actually pay. I would assume that none of them are paying the full “sticker” price.
I verified with the company that the following payment information is correct as of May 15, 2017, but it is subject to change, of course:
Out of pocket: $1750 for the Psychotropic test. The MTHFR test alone is done at no cost.
Medicare: no copay
Medicaid: no copay
Commercial plans/ Medicare Advantage: Patient assistance program. (The details regarding this are different in New York. )
References
Their website is https://genesight.com
Altar CA, Carhart JM, Allen JD, Hall-Flavin DK, Dechairo BM, Winner JG. Clinical validity: Combinatorial pharmacogenomics predicts antidepressant responses and healthcare utilizations better than single gene phenotypes. Pharmacogenomics J. 2015 Oct;15(5):443-51. doi: 10.1038/tpj.2014.85. PubMed PMID: 25686762.
Altar CA, Carhart J, Allen JD, Hall-Flavin D, Winner J, Dechairo B. Clinical Utility of Combinatorial Pharmacogenomics-Guided Antidepressant Therapy: Evidence from Three Clinical Studies. Mol Neuropsychiatry. 2015 Oct;1(3):145-55. doi: 10.1159/000430915. PubMed PMID: 27606312; PubMed Central PMCID: PMC4996033.
Hall-Flavin DK, Winner JG, Allen JD, Carhart JM, Proctor B, Snyder KA, Drews MS, Eisterhold LL, Geske J, Mrazek DA. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenet Genomics. 2013 Oct;23(10):535-48. PubMed PMID: 24018772.
Rosenblat JD, Lee Y, McIntyre RS. Does Pharmacogenomic Testing Improve Clinical Outcomes for Major Depressive Disorder? A Systematic Review of Clinical Trials and Cost-Effectiveness Studies. J Clin Psychiatry. 2017 Jan 3. [Epub ahead of print] PubMed PMID: 28068459.
Winner JG, Carhart JM, Altar CA, Allen JD, Dechairo BM. A prospective, randomized, double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. Discov Med. 2013 Nov;16(89):219-27. PubMed PMID: 24229738.
Winner JG, Carhart JM, Altar CA, Goldfarb S, Allen JD, Lavezzari G, Parsons KK, Marshak AG, Garavaglia S, Dechairo BM. Combinatorial pharmacogenomic guidance for psychiatric medications reduces overall pharmacy costs in a 1 year prospective evaluation. Curr Med Res Opin. 2015;31(9):1633-43. doi: 10.1185/03007995.2015.1063483. PubMed PMID: 26086890.
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