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Point-of-Care Genomic Testing; Best Offered in a Lab-Managed Setting

Posted May 04 2012 12:00am

The menu of point-of-care testing is now beginning to include DNA analysis according to a recent report (see: Bedside Genetic Test to Predict Complications in Cardiac Stent Patients ). It's a test for the genetic variant CYP2C19 which codes for a member of the cytochrome P450 super-family of enzymes. Below is an excerpt from the article:

Researchers from the University of Ottawa Heart Institute published [a study that] demonstrates one of the first point of care tests for personalized medicine. A simple cheek swab test performed by nurses at the patient’s bedside rapidly identifies a genetic variant known as CYP2C19*2 . Cardiac stent patients with this variant are at risk of reacting poorly to standard antiplatelet therapy with Clopidogrel. The genetic testing successfully protected all of the patients with the at-risk genetic variant from subsequent adverse events, while 30% of patients treated with standard therapy did not receive adequate protection....The genetic testing was done on the Spartan RX PCR machine developed by Spartan Bioscience, a sample-to-result point-of-care DNA testing system.  The Spartan RX CYP2C19 has CE IVD Mark regulatory approval for Europe and other countries recognizing the CE IVD Mark. Spartan Bioscience is working towards FDA clearance in the United States.

I am generally in favor of point-of-care (POC) testing because I think that it can facilitate healthcare delivery. However, a couple of conditions apply to this blanket statement, two of which are that the test results generated by the POC devices need to be inexpensively and efficiently integrated into the LIS database. POC device manufacturers do not always have such a goal when they first bring these devices to market. The second condition is that such devices need to be managed in an environment where quality control standards are adhered to that are identical to those in the central lab environment. For glucometers used in bedside testing, the best strategy is to provide QC oversight by lab professionals over the entire program.

In my opinion, genomic bedside testing is so complex that it requires a high level of control by lab professionals. Unfortunately, diagnostic companies entering this space are aggressively marketing the devices directly to clinicians to rapidly increase the size of the market. Central lab personnel are often excluded from these discussions. One example of such a company is DxTerity and below is quote from the company web site (see: Complex genetic tests—without the complexity ). 

By enabling complex gene signatures to be run at the point of care on a simple-to-use, quick, and affordable platform, DxTerity can help drive genomic market growth. This will allow practitioners, for the first time, to have a complete individualized patient assessment prior to prescribing a treatment for many of the major disease states that affect millions of people worldwide and consume many of our healthcare resources. 

This approach can only harm the genomic testing field because it will yield a high percentage of unreliable test results. It would be helpful if the various professional societies that have a stake in genomic testing would establish criteria for the overall management of genomic-testing POC devices.

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