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Respiragene as a "Not So Useful" Lung Cancer Risk Test Comes to Market

Posted Nov 12 2009 10:02pm

We are entering the golden era of diagnostics ushered in by new biomarkers with greater specificity, measured alone and in also in groups called IVDMIAs. For me, the value of any lab test is whether the integrated result provides key diagnostic or therapeutic information that is otherwise unobtainable. A recent story appropriately questioned the value of a new lab test now being marketed for lung cancer (see: Questioning a Test for Cancer ). Below is an excerpt from it:

Christopher Taylor says he never lasted more than a week when he tried to quit smoking in the past. But it has been four weeks and counting this time, since a genetic test indicated he had a much higher risk of developing lung cancer than the average smoker. Of course, said Mr. Taylor, a 45-year-old salesman who has smoked for 25 years, he already knew that cigarettes were dangerous. But he thought, “It’s not going to happen to me.” Then came the gene test....Scaring people into quitting is the marketing rationale for that new genetic test, called Respiragene, which purports to identify which smokers have the highest risk of developing lung cancer. The test, developed by a company called Synergenz BioScience in New Zealand, where Mr. Taylor lives, is now being offered over the Internet in the United States for $700....Respiragene has not been approved by the Food and Drug Administration, which usually does not regulate such tests. Some states do, however, and the test has not been approved for use by residents in New York, California and Maryland.... The justification for many of these tests is that knowing one’s risk will prompt people to change their behavior. Such is the premise, for example, of the genome scans offered by 23andMe, costing $400, and one by Navigenics, for $1,000, that are meant to tell one’s propensity for numerous diseases. Navigenics and an organization affiliated with the Scripps Research Institute are now monitoring 4,800 people to see if the Navigenics test results prompt them to eat better, exercise more or get more medical checkups. But smoking could prove the clearest test yet of the behavior modification pitch.

As far as I can determine from this story, Synergenz BioScience developed this test by choosing a list of biomarkers that can purportedly determine whether one is at "high risk" for lung cancer. I take this to mean that one is predisposed to the disease and that this predisposition can be exacerbated by smoking or by being exposed to other risk factors. The company then markets the test based on the premise that it's more "scary" than having your physician say that you are at higher risk. Although not referenced in the story, the picture of the Respiragene report shows the MDL logo, referring to what I assume to be the performing laboratory for the test, Molecular Diagnostic Laboratories. This lab's web page also displays the Respiragene logo.

This notion of using a genetic test to assess whether a current smoker or a previous smoker is at risk for cancer strikes me as sketchy, particularly for a price $700. Here's what I would recommend instead. Stop by one of the local panhandlers on the street, hand him $10, and tell him that you have a 20-pack-year history of smoking. Then, ask him if you have an increased risk of developing cancer. I also suspect that some smokers who don't want to quit smoking are using the test to determine if they are in the lucky minority who have a low cancer risk and can thus continue with their addiction. It's not worth it, pal.

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