A handful of genetic tests are required by FDA, especially in new oncolytics, as companion diagnostics for prescribing certain drugs; the genetic testing identifies patients especially well suited to the drug (or, conversely, known to be poorly affected). But there are a wide variety of genetic profiles known to influence the effects of many common drugs, ranging from statins for lipid control, to blood thinners in cardiovascular care and others. Here, genetic profiling is sometimes carried out, sometimes not; physicians are accustomed to trying one drug, seeing how it goes with the patient, and then switching to another. Insurers have an on-again, off-again approach to reimbursing this testing as well.
Now, a diagnostics company, MD Labs (Reno, NV) is marketing its profiling service, branded as Rxight, via pharmacies. Hundreds of independent pharmacies have made the test available to consumers over the past year, and in the past week, a regional pharmacy chain, Fruth Pharmacy, with 29 locations in West Virginia, Ohio and Kentucky has signed on. “We look on this as an extension of the role pharmacists play with our clients; our pharmacists are often their most trusted healthcare advisor,” notes Lynne Fruth, president. “In addition, pharmacists have a traditional role of being experts on the medications themselves, advising physicians on contraindications.”
MD Labs, a CLIA-certified facility, characterizes its version of genetic testing as “open array technology to identify 60 alleles present on 18 genes that determine the metabolism of over 200 medications.” Matthew Rutledge, cofounder and CEO, says that its results are 99.98% accurate; the testing produces a report branded as a Personalized Medication Review, which is shared with patients and their physicians. Therapy classes involved include oncology, cardiovascular, behavioral health, gastroenterology and pain management, among others. In practice, a physician’s authorization is the first step, then the patient purchases the test kit at the local pharmacy (the kit [see photo] includes simply a collector for a cheek swab; the swab is then sent to MD Labs for analysis.) The test costs $400, which Rutledge says puts Rxight above the test performed by 23andMe (the basic test, mostly for ancestry analysis, costs $99), but well below other testing services that cost $1000 and up.
With today’s emphasis by Medicare to reduce hospital readmissions, the ability to preview potential adverse events or unwanted side effects is a powerful tool for physicians and health plans, and Rutledge says that a few hospital pharmacies are also customers. Over time, he expects that the test will become relevant to even more types of drugs; to date, interactions with pharma companies themselves has been minimal, but his hope is that the testing will become a more integral part of both healthcare delivery and pharmacovigilance reporting.