Luminex Corporation announced Wednesday that it has launched its first pharmacogenomics test. The test, called the xTAG CYP2D6 Kit, recently received 510(k) clearance from the U.S. Food and Drug Administration and is designed to facilitate the practice of personalized medicine by helping physicians to identify which patients may not respond to certain medications.
CYP2D6 is an enzyme that is involved in the metabolism of approximately a quarter of prescription drugs, including beta blockers, SSRIs such as Prozac and Luvox, and tricyclic antidepressants. Patients may have a version of the CYP2D6 gene that is associated with abnormal drug response. Those with this genetic variant are more likely to experience adverse drug reactions or failure of treatment. Physicians may choose to prescribe alternative treatment doses and monitor drug levels.
Luminex Corp. joins companies such as Clarient, QIAGEN and Curidium in the personalized medicine diagnostics space. Personalized medicine is based around the concept that factors such as genetics, proteomics and lifestyle can play an important role in a patient’s health. Diagnostic tests that identify biomarkers associated with the development of illness or treatment response are an integral part of this individualized approach. By identifying which patients are at risk for a particular disease or may respond poorly to a certain medication, physicians are able to make more informed treatment decisions.
In these budget- and health-conscious times, personalized medicine is gaining mainstream attention for its potential to shorten treatment time, decrease side effects, reduce medical costs, and improve patient outcomes. Last month, the Wall Street Journal reported that pharmaceutical companies such as Roche and Abbott Laboratories are jumping into the field of personalized medicine with their own diagnostic tests. In the article, two breast cancer patients discuss how Abbott Labs’ PathVysion test helped them receive the appropriate treatment. Although not mentioned in the WSJ article, the recent acquisition of molecular diagnostics company Clarient by GE Healthcare for approximately $580 million also highlights the growing value pharmaceutical companies are placing upon personalized medicine.
Hospitals are getting in on the act as well: Fox Chase Cancer Center in Philadelphia plans to partner with the Ignite Institute for Individualized Health to launch an institute aimed at providing personalized medicine to cancer patients. The new site, to be called the Cancer Genome Institute, will be home to the largest genome sequencing effort in the U.S.
PricewaterhouseCoopers forecasts that the diagnostic and therapeutic segment of the personalized medical care market will grow 10 percent annually to reach $42 billion by 2015, and that the market for personalized therapies will grow 11 percent per year to reach $452 by 2015. Although the personalized medicine market is faced with major challenges, such as widespread adoption by healthcare providers, it's clear that personalized medicine is making significant headway as an approach to healthcare.