The connection between the human genome (complete set of your DNA) and medications has been a matter of study for years, however, due to limited evidence, healthcare providers have been cautious in adopting genome-based diagnostics. To ascertain the evidence needed to make these genome-based tests of clinical value, a workshop hosted by the Institute of Medicine’s Roundtable titled “Genome-Based Diagnostics: Clarifying Pathways to Clinical Use” was held in November 2010.

The sequencing of the human genome and the identification of associations between specific genetic variants and diseases have led to an explosion of genomic-based diagnostic tests. These tests have the potential to direct therapeutic interventions and predict the risk or inception of disease. As research progresses and an increasing number of associations are found, further tests will be developed that can aid in providing personalized treatment options for patients.

Despite these advancements, the adoption of genomic diagnostic tests by healthcare providers has been limited due to a lack of evidence regarding the clinical utility of many tests. Health funders and practitioners lack the data necessary to distinguish which tests can improve practice or the clinical settings in which tests will provide the greatest value. The 2010 workshop highlighted the need for better mechanisms to generate this evidence and discussed new models, strategies, and specific actions for developing genomic diagnostic tests of clinical value.

Genome-Based Diagnostics and Pharmacogenomics:

Advancements in Pharmacogenomics have led to the success of genome-based diagnostics and medications. A simple pharmacogenomics test, commonly known as a PGx test, can give insights into your genetic makeup. These reports help doctors tailor drugs and doses based on genome data and avoid medications that can have adverse effects on an individual. An at-home pharmacogenomics test by RPh LABS, requiring just a saliva cheek swab can show you how your body may respond to 250+ medications, and suggest alternates as well.

FDA and Pharmacogenetic Tests

According to the FDA, “Pharmacogenetic tests, along with other information about patients and their disease or condition, can play an important role in drug therapy”. The institution further added that the “knowledge of a patient’s genotype may be used to aid in determining a therapeutic strategy, determining an appropriate dosage, or assessing the likelihood of benefit or toxicity”.

Furthermore, certain drugs are labeled by the FDA as they may affect individuals differently, such as Tetrabenazine (Xenazine) dosages above 50mg per day should be genotyped to know the type of metabolizer a patient is. This drug is primarily metabolized by the CYP2D6 enzyme, thus knowing if someone is a poor or extensive metabolizer guides doctors to administer dosages accordingly and avoid adverse effects.

PGx Tests Insurance Coverage

While pharmacogenomics (PGx) testing may be vital in removing trial and error from medication, especially mental health medication, reimbursements can be tough. The insurance coverage and reimbursement of your PGx testing claims may be subject to the therapeutic condition, the diagnosis code used, and a few more factors.

Keeping in view the coverage difficulties, we at RPh LABS offer easy payment options where you can pay in 4 chunks with 0 interest charged whatsoever. Taking a test is easy, here is how it works.

References:

https://www.ncbi.nlm.nih.gov/books/NBK100164/
https://primo.qatar-weill.cornell.edu/discovery/fulldisplay/alma991000574149206691/
https://pubmed.ncbi.nlm.nih.gov/22934323/

Disclaimer: This blog is for informational purposes. Please always consult a doctor before taking any medical action.