Evidence-Based Oncology

Genetic Testing Should Come With Counseling: American Cancer Society CMO, Supreme Court Plaintiff Among Experts Who Warn of Consumer Risks | Page 5

Published Online: December 13, 2013
Produced by Nicole Beagin
Matloff: I think one of the concerns is that there are also some testing companies offering direct-to-consumer testing. You can order the test online; you can have a kit sent to your home. You can provide a DNA sample by saliva and send it back. Some of those companies have been studied extensively; the Government Accountability Office (GAO) found that if you send the same sample to 4 different laboratories, you will get 4 different sets of results and risks. Some of these companies are dodging FDA and FTC standards by saying they’re for entertainment instead of medical use. We recently had a rabbi in our community contact us and say that one of these companies reached out and gave the congregation 100 free tests, and that he was going to launch it at high holiday services and tell people, “Oh, we’ve got this testing, and if any of you come back with something, then you can go see a genetic counselor.” So I do think there’s room for error with unregulated testing. In terms of what I’ve seen so far, and I’d be interested in what my fellow counselors think, but in terms of BRCA testing, most of the companies that I’ve seen offering test so far have been through pre-approved laboratories doing quality testing. I haven’t had any major concerns in the BRCA market to date.

Nagy: Yes, I agree the companies have done a great job. One concern early on was that Myriad held a proprietary database and would not share with the public what would characterize uncertain variance, or variance of uncertain significance. The talk was that these other laboratories didn’t have enough of those data to be able to call mutations deleterious or just natural polymorphisms or truly uncertain variance. But we’ve not had that issue come up for us. From what we’re hearing, these laboratories have robust data, have variant rates that are very similar to what Myriad is reporting. So I think in my center, our initial hesitancy was 2-fold. It was, “What is their variant call rate?” And then, “What is the insurance coverage within that laboratory?” Over time, those have both been answered.

Berger: We’ve talked mostly about BRCA and other associated tests with breast cancer and breast cancer risks. Where are some of the other areas you’re seeing both today and in the near future as a trend?

Matloff: In the cancer realm, at least at my center specifically, I think there’s a lot more awareness of ovarian cancer being part of the spectrum as well as pancreatic cancer, as there should be. We recently have launched a hereditary renal cell clinic. So at least here in the cancer realm, I think that’s where the next areas will be.

Nagy: At our center our cardiovascular program is just taking off. We’re seeing patients who have either diseases of the muscle of the heart or diseases of conduction that have a very, very strong genetic component. So we are gearing up to really expand that clinic. I think the other area where historically genetic counselors haven’t been as heavily imbedded as perhaps they

should be is in neurology; from what we’re hearing, neurologists are adopting some of these newer tests, like whole exon, whole genome for their patients who have something clinically, but they just can’t figure it out genetically.

Berger: Dr Finley, are you seeing requests in other areas?

Finley: Yes, we are, but it’s all over the place. What we’ve done—as we do for most medical services—we identify the services—in this case genetic tests—that are most frequently requested. And we have to make a determination whether we’re going to subject them to utilization review management. So we have about 40 or 50 tests that are on our policy list for which we get frequent requests, and that we have decided it is appropriate to do a utilization management. But I wouldn’t say that there has been any that have popped up recently. I’m not aware of any. …

Nagy: The other area where in the next 5-10 years we’ll see a trend is within the pediatric setting, or the NICU setting where a child is born with a condition that looks to be genetic, and that’s another area where those whole-exon, whole-genome tests might play a br /> cost comes down I think we’ll see a lot more utilization there.

Berger: Let’s talk about future trends. If you were to look into your crystal ball in the general area of genetic testing, what do you see coming? Do you think you’ll see more requirements of genetic counselling before genetic testing? Do you think more and more people will do these home testing? And although there is a natural inquisitiveness, I can only see that increasing other  healthcare activities by the so-called “worried well.” But what are the other trends you see? I think one of the other issues we should discuss is genetic testing around the right drug, right dose, right time.

Brawley: I’ll jump right into that because I treat cancer patients all the time. I am really mortified at some of the things that patients bring to me for second opinions, where they have spent lots of money, sometimes undergone unnecessary biopsies to send fresh tissues to labs to do things which, quite honestly, are experimental. They might ultimately prove to be beneficial, but they use usually the home-brew loophole in FDA regulation to actually start marketing something that is not ready for prime time.

Nagy: Dr Brawley, I agree with you. In our cancer center we want that to occur still within the research setting. But I do think there is potential for those types of tests in tailoring treatments and opening up clinical trials to not be so focused on the clinical aspects of the patient, but more on the genetic aspects of the tumor. It has great potential. But at our institution we’re trying to keep that within the research realm at this point, so that we can gather enough data to show that it has value, and then let it go into the clinical setting at that point.

Berger: Dr Finley, are you seeing people request that kind of genetic testing around medication dosing and right drug at Cigna?

Finley: Yes, we do, and we have policies for the most frequently requested test of that sort. What we do is we apply our general criteria toward medical coverage. The basics are that the service, and in this case we’re talking about pharmacogenomics the service has to be proven by evidence published in the peer-review literature to be associated with beneficial health outcomes. And

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