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The Benefits of Pharmacogenetic Testing

Pharmacogenetic testing refers to a type of genetic test to predict a patient’s likelihood to experience an adverse event or not respond to a given drug. Despite revision to several labels of commonly prescribed drugs regarding the impact of genetic variation, the use of this testing has been limited in many settings due to a number of factors. As a pillar of the personalized medicine movement, pharmacogenetics for physicians is anticipated to be important across all medical specialties particularly with the increasing popularity of concierge medicine.
Several pharmacogenetic tests have been developed, based on the data from numerous genomic studies to correlate genetic variation with variable drug response. A handful of these tests, both protein- and DNA-based, have subsequently been approved for in vitro diagnostic testing.
Pharmacogenetic testing is currently available for a wide range of health problems including cardiovascular disease, cancer, diabetes, autoimmune disorders, mental health disorders and infectious diseases. PGx contributes important information to the field of precision medicine by clarifying appropriate treatments for specific disease subtypes. Tangible benefits to patients including improved outcomes and reduced total health care costs have been observed. Coverage by insurers is a critical step in achieving widespread adoption of pharmacogenetic testing. The acceleration of adoption of precision medicine in general and for pharmacogenetic testing in particular will be determined by how quickly robust evidence can be accumulated that shows a return on investment for payers in terms of real dollars, for clinicians in terms of patient clinical responses, and for patients in terms of economic, health and quality of life outcomes.
In 2005, the FDA approved the first pharmacogenetic test based on microarray technology for genotyping 27 alleles in CYP2D6 and three alleles in CYP2C19 genes associated with different metabolizing phenotypes. Today, pharmacogenetic testing has become an integral part of the treatment of breast cancer with trastuzumab. Overexpression of the HER2 oncogene is correlated with a poor prognosis, increased tumor formation and metastasis, as well as resistance to chemotherapeutic agents. HER2 testing predetermines patients who overexpress HER2 and who will respond to trastuzumab.
With rapid advances in genomic technology, costs of pharmacogenetic testing have decreased in recent years. In addition to improved treatment outcomes, genetic testing can reduce high costs related to treatment failures and severe adverse events.







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