Personalized Health Care Initiative Workshop: "Understanding the Needs of Consumers in the Use of Genome-based Health Information Services". Panel 2: is the Testing Process Reliable, and is the Information?s Privacy Maintained?

07/07/2008

Dr. Reed Tuckson is going to chair the panel. This panel will be addressing -- where’d I go, lost my -- addressing issues on genetics, health, and society. Dr. Tuckson chaired the Secretary’s Advisory Committee on Genetics, Health, and Society. So without expanding anymore, I’ll let him take over, introduce his panel, and we’ll get started.

DR. TUCKSON: Thank you. Good, good. Good afternoon. Good afternoon.

AUDIENCE: Good afternoon.

DR. TUCKSON: Now, you’re all going to wake up one way or the other, so we’re just not having -- and if we could the people in the back to come on in because I’m not going to have my first panelists talk to confusion.

Now, we’re going to change the order a little bit because we decided that we wanted to. And so we can do that. There are two issues really before us in this section. And again, just to orient you -- is the testing process reliable and is the information’s privacy maintained? And so I’m going to break those into two distinct sections. And we’re going to start with this question of is the testing process reliable? Well, this has been, as all of you as astute observers know, a fundamental issue in this field for many years. I think most of you are familiar with the work of something called the Secretary’s Advisory Committee for Genetic Testing, which was formed several years ago. And that Advisory Committee’s whole function was to try to get at this question of the adequacy of the oversight of genetic tests. And that is work that continues forward to this day.

The question then becomes is, is it in fact true that genetic tests are reliable? And one of the good things that is occurring in this area to give us a better sense of it and to give us greater assurances, is the new Secretary Advisory Committee on Genetics, Health, and Society. The audience being extremely populated by many of those good people and former colleagues of mine, I see.

They have put forward an important report to the Secretary, which is now being analyzed by the Secretary’s Office. I will tell you that that report does raise some important issues about the adequacy and the reliability of the oversight of genetic tests. In fact, I see government holding up a copy of it right now. Government is in the room. And so the real issue is that there are issues here, and so without going further into it, we have some perspectives. Question related number two is, do consumers really care if it’s reliable? Do consumers really have a position on this? Don’t most people just say, “Well, of course the government has taken care of all of this.” Don’t most people say, “I don’t know any difference between genetic tests and all the other tests, I just assume it’s a holistic -- big hole -- and somebody is taking care of it.” So the question becomes, do consumers really care if it’s reliable, or do they just expect it.

And then finally, do consumers actually perceive that there is a problem? Whether they care about it or not, do they think there is a problem? And if they think that there is a problem, do they perceive it in a way that is determinant? Does their perception of reliability cause them -- or their perception of non-reliability or uncertainty -- cause them to act or not act in a certain way?

And so those are some of the questions that would logically derive from our organizers asking, is the testing process reliable?

Let me then switch to the second half of their challenge to us. Is the information’s privacy maintained?

Well, a big contextual issue here is of course whether or not you will be discriminated about because of the information. We are all, I think, celebratory of the GINA Bill, and that was a long-fought effort by a lot of people, many of whom are in this room today. And so at least that starts to give us some sense as we frame this conversation around protection of misuse of the information. Still, is privacy maintained in fact, and is it maintained in a way that is more or less stringent than in other areas of medicine? We come back to this question of genetic exceptionalism; is the privacy of information in genetics more or less maintained than in other areas of medicine. And secondly, is this an issue of concern for consumers, and is their concern determinant. Do people worry about this privacy of information, do we have any sense that the GINA Bill has taken away the concern around misuse, and now it’s a question of essential, just privacy for its own sake. And is that concern determinant? Does it result, or will it result, for example, in an unavailability of this information for coordination of care and disease management resources.

I think most of you in the audience are aware that today’s health care system with chronically ill people -- the health care system is organizing itself to be able to use data and information to help navigate people through a fragmented care delivery system, helping to get people to the full array of the services -- the comprehensive services that may be associated with their clinical condition. Will concern for privacy cause the unavailability of that information to be used for these critical purposes and have an interesting inadvertent result? And that being, that people with chronic disease, people with complex illnesses who need lots of care coordination, won't be able to get it because of people’s concern around privacy, thereby not making the information available, and then compromising health status.

Will people’s concern about privacy result in the unavailability of this information to share with family? And so what will it do to family dynamics at Thanksgiving dinner? And will it mean that there will be some people at dinner who will hope that certain people at dinner, like the moderator, will be quiet and just not talk about things. Will there be some family members who will notice that other family members have gotten prophylactic surgery, and thereby will have information that they wished that they had not had. And what does that do to the dynamics of family life? And finally, will this concern cause a chilling effect on public health surveillance and population-based prevention and research? And so the question is, ultimately, do anxieties have determinant outcomes in this field?

Well, with that as a table setting, let me turn to our speakers. Do not be distracted by the agenda on your program because it’s wrong. Our first speaker is going to be Jeffrey Gulcher, who is the Chief Scientific Officer for deCODE genetics. Not only is he here because he’s one of the founders of deCODE, but he’s also here because his colleague is stuck in Switzerland.

DR. GULCHER: Iceland.

DR. TUCKSON: Same thing. [LAUGHTER]

DR. GULCHER: Not if you’ve been to Iceland, sir.

DR. TUCKSON: A long way away is the point. So we’re very pleased, though, that Jeff is here. And Jeff is going to really focus in a bit on this issue of reliability of clinical tests. And we’re very happy that you are here, Dr. Jeffrey Gulcher.

DR. GULCHER: Thank you. I just want to point out that we’ve spent a lot of time thinking about genetic risk test because we’re also a diagnostics company and we make available through our reference laboratory, laboratory-derived tests for genetic risk for individual diseases in addition to deCODEme, which sums up those diseases and adds some additional diseases that we have not yet developed tests for, and offered it as an individual set of tests. But when it comes to reliability, it’s really important to emphasize that the genetic risk tests that we’re all putting together are risk factors, they’re risk markers. They are not pathoneumonic for a disease, so therefore they’re not really a true diagnostic from that point of view. They’re certainly not a determinative test either from a genetics point of view because this is not like the Huntington’s disease gene, that if you are positive for that single gene for Huntington’s, you will get Huntington’s no matter what you do. Conversely, if you don’t have a mutation in that gene, you will not get Huntington’s disease no matter what you do. For the common diseases it’s an interplay between genetics and the environment, and no single gene is going to determine absolutely whether or not you’re going to develop a heart attack or a stroke. So really these tests, when we put these tests together, and in some cases these are single or two-marker tests, and other cases they are eight-marker tests. For example, in our prostate cancer test, eight markers together define risks compared to the general population of developing prostate cancer, anywhere from .4-fold up to 7-fold. So for a patient who has a high risk for prostate cancer, they’re not going to be told that you’re definitely going to develop prostate cancer. And for somebody who has a lower risk based on a genetic profile, that patient is not going to be told that you are immune from prostate cancer, and therefore you should not get PSA testing, for example, as a screen.

Just as physicians -- Dr. Topol will tell his patient who has the upper quartile, quintile of LDL cholesterol, he’s not going to tell the patient, “You are definitely going to develop a stroke or an MI,” right?

“But we need manage that risk factor for you.” And the patients that he has -- or the lower quintile of LDL cholesterol, he’s not going to tell them, “Let’s not pursue any other risk factors or manage your other risk factors” because the number one cause of death in patients with a lower quintile of LDL cholesterol is still MI and stroke. Right? So as physicians, we know how to deal with risk factors, we know how to manage them low-risk or high-risk; the key is to be able to put those together in the context of other risk factors and use them to prioritize patients to those who deserve maybe more attention when it comes to earlier diagnosis of cancer, or to motivate them to change their lifestyles or manage those other risk factors (inaudible). If indeed the information does add new information that’s not already being assessed, and Dr. Khoury would suggest that maybe some of this information is redundant with what we’re already capturing today with either family history or the other risk factors. And I would contend the important thing to realize is these common genetic risk factors are adding something much beyond family history. They do not account for the vast majority of family history, these are not rare variants of high effect, and if you look at paper after paper, our own discoveries and others, it does not capture family history. So family history alone will not substitute for this genetic profiling.

Conversely, 95 percent of prostate cancer patients do not have a family history of prostate cancer -- of diagnosed prostate cancer. And so you can't rely just on that. If these tests are useful for those who don’t have a family history, it’s adding -- by definition, it’s adding additional information -- risk information beyond family history, so they’re not substitute, although they can be interchanged.

So when it comes to reliability, it’s important to communicate to the patient and to the physician that these are not determinative. So if somebody says, “Is this a reliable test? This is going to predict that I’m going to have a stroke?” No, you can't say that. You can only say that this is a risk ratio compared to the general population risk and there are other risk factors that need to be measured -- environmental risk factors and other things -- and there are many genetic risk factors that we do not know yet. But still this information may in certain cases be useful to act upon through your physician.

Now let’s move back -- so that’s reliability in terms of the interpretation of the information, but then there’s been some suggestions by others that maybe we can't measure the genotypes -- the genetic information, very accurately, or that we can't really tell the FDA or CMS how accurately we do measure. That’s what the so- called analytical validation component of a diagnostic.

The analytical validation for a genetic test -- the reliability of that measurement of that information is much easier to measure yourself or determine it’s accuracy yourself as a laboratory, much easier to demonstrate to the FDA or CMS that you are accurate because genetic information -- it’s pretty cut and dry, at least these single-based changes that Dr. Topol mentioned. Very easy. Sequence-based -- you sequence the genome -- or sequence that one little location in a set of patients, which is considered by the FDA the gold standard for genotyping, and match it with your genotyping platform. And what’s the concordance rate? And the concordance rates I would guarantee for all three of our companies is very, very high indeed -- 99 percent -- 99.9 percent plus. But it’s easy to demonstrate to the regulatory bodies how accurate that is, and to communicate that to our patients. So when we talk about reliability we can measure reliability; much more reliable than demonstrating how reliable can we measure CRP or other -- or even LDL cholesterol or other biomarkers that fluctuate and have interfering substances within the sample that you’re measuring. A lot easier to describe that and document that.

Let’s move on to the clinical validity; that’s the second piece of CMS or FDA when it regulates a diagnostic. The clinical validity -- and if you move to my first slide -- I just want to summarize. The genetic risk tests that we provide are very well clinically validated indeed. If the definition of clinical validity is that you discover them in one population and then you replicate them in multiple populations. That’s the definition. We’re not talking about clinical utility; we’ll get to that later. But clinical validity, does it replicate, does it have the same effect in multiple populations? And so for the markers that we provide, these same set of markers have been replicated in multiple populations. In some cases they’ve only been tested in Caucasian populations; other cases, they’ve been tested in other ethnic populations and been replicated, but the point is, they are clinically validated in the populations that are being claimed.

So when you sum up all of the patient populations that are behind, let’s say the diabetes markers or the prostate cancer markers, you realize that the number of patients and controls together, are in the tens of thousands. In many cases, you have over 10,000 patients behind that. For the MI test, for example, or 5,000 patients versus 30,000 or 40,000 controls. So you have a lot of data behind them -- larger data sets behind these tests than for most FDA approved diagnostics and therapeutics. So they are well validated from the standpoint of replication, and then when it comes to estimation of what that risk really is, we’re not using 200 or 300 patients to estimate what is the true relative risk of this particular genotype in these Caucasian populations, we make use of these full tens of thousands of patients to estimate that relative risk. Right? Just as a clinical trial uses thousands of patients to define what the relative risk reduction is due to a drug, all right, but these are tens of thousands that are estimating this particular risk across populations, and we think that’s a pretty good estimate. To have a higher precision than that, we’d have to 500,000 patients or so. Right. So we think that the clinical validity for many of these tests is already there. And I should also mention that these markers can -- you can demonstrate with these large population sets that they are independent of each other, meaning that they don’t -- they’re not synergistic or redundant with each other. And so therefore you don’t have to come up with complicated models of how to put these eight different prostate cancer markers together to define the risk for that particular patient, you can first convert the odds ratios that we typically report in all of our publications to risk ratios -- relative risk compared to the general population so that you have a standard population by which the risk is compared. And then because there are independent risk factors for prostate cancer, you can simply multiply the genotype specific risks for each of those eight markers together to define the composite genetic risk compared to the general population. This is what physicians have been doing for a century -- multiplying independent risk factors together to define composite risk. So we think that’s a way in which -- think it’s easy for physicians to in general understand how we’re doing this, as long as we’re transparent on how we define clinical validity.

If you go to the next slide, this answers the so what part, which is really important to have in this discussion about analytical and clinical validity because if this stuff -- if this information is not useful in certain circumstances, then why are we even having this discussion? Should we wait until another 50 different genes for Type 2 diabetes have been discovered? Or is this information useful today? If we had waited for the assessment of HDL or some subparticle sizes for LDL -- should we have waited before we measured total cholesterol or even LDL cholesterol, waited for the additional nuances of cardiovascular risk? No. We use the information as we discover it as long as it adds something new; and I would contend that it does indeed add something new. The heart attack variance that Dr. Topol mentioned -- we’re talking about a 1 -- it’s a modest risk, 1.3 to 1.5, depending on the age of onset of risk. But this is an independent risk factor, independent of LDL cholesterol, hypertension, smoking, family history -- risk factors that are routinely measured but this is not routinely measured. It adds something. There is a recent study that showed -- prospective study that showed, yes, there wasn’t much of a change in the AUC for cardiovascular risk, it only went from 62 percent to 64 percent, not significant. But there was a significant re-classification of patients between the low, intermediate, and high-risk categories based on ATP3 criteria, which most physicians use today.

Substantially -- about 15 percent of patients got reclassified. So here’s an example where there is something you can do differently about it; you can change the target level of LDL cholesterol if a patient rises to a different class. Prostate cancer, eight markers that define this risk that I mentioned. Breast cancer, we’re about ready to launch a test for breast cancer -- individual test. Eight markers that -- 5 percent of the general population is at 2-fold risk for breast cancer independent of BRCA1 and BRCA2. This is for more of the late-onset breast cancer, which has a much bigger public health impact than the rare form -- early-onset form of breast cancer. And so it provides another way of assessing risk that compliments BRCA1 and BRCA2 for the different -- for the usual form of breast cancer. Type 2 diabetes, 10 percent of general population -- or pre- diabetics, actually convert at a very high rate to Type 2 diabetes. Fifty to 70 percent absolute risk within three to four years; this is based on the DPP and DPS study, a clinical trial where the genetic markers were added.

And then finally I want to mention before I go to the case study, atrial fibrillation, we discovered markers for atrial fibrillation that we then asked the question, what’s the clinical utility? Applied them to a series of stroke cohorts, and identified that there’s a large portion of patients with cryptogenic stroke that are not being diagnosed with having atrial fibrillation. They go in and out of atrial fibrillation. The public health impact of not making the diagnosis -- proper diagnosis of a fibrillated stroke is immense because anti-platelets do not work very well for prevention of stroke related to AF.

But Warfarin does, it cuts down stroke risk by about 60 to 70 percent. If -- in order to use this test today in the health care system today, we estimate 150,000 patients would be diagnosed with atrial fibrillation related stroke that are not already being diagnosed, and it could save Medicare $1 billion a year if applied in that particular manner. So it can have an impact, but only if you pick certain niches where there is a clinical utility that you can demonstrate.

Next slide. So finally, I just want to give you a case study, which was my own. I have a family history of prostate cancer, but it’s the late-onset version. My father had prostate cancer when he was over 70-years-old, a benign form. The AUA Guidelines would not suggest that I be concerned about earlier onset prostate cancer because my father had such late onset, and the guidelines suggest that if you only have a family history of a father or a brother over the -- of prostate cancer with onset younger than 65, that you consider doing PSA testing at an earlier age than normal. Normally, it’s recommended that you start getting PSA testing at 50; if you are at higher risk, it’s suggested that you get PSA testing at 40.

Since I’m more compulsive, I went ahead and got my PSA tested anyway at 42, and I was completely below normal. Then I got my deCODEme results back when we updated it with the eight markers, and my relative risk was now 1.88 just on the basis of my genetic profile alone. Lifetime risk for a white male is 16 percent, so I’m double that risk. And by the way, there are no other risk factors for white males when it comes to prostate cancer. There’s not some other identifier that can help my physician decide, do I want -- should I test or not? Also, the markers suggest that I had moderately increased risk for aggressive versus non-aggressive prostate cancer. So the high risk prompted my primary care physician to refer me to a -- sorry -- the high risk prompted my primary care physician to go ahead and measure my PSA. I’m only 48- years-old so I normally would not have had my PSA tested at this time. My PSA was high-normal at 2.5; the range is from 0 to 4. Some people use different cutoffs depending on additional risks, like family history. But the high risk prompted my primary care physician to refer me to a urologist. The high risk prompted him to recommend a ultrasound-guided biopsy, which was positive for intermediate grade prostate cancer with about 20 percent of my prostate is filled with cancer. If I had not had this information, my primary care physician probably would not have ordered the PSA, he probably would not have referred this normal range PSA -- high-normal range PSA to a urologist for additional evaluation, and maybe my urologist would not have recommended an ultrasound-guided biopsy. Two weeks ago, I was scanned -- I had a bone scan and I had a normal CT, so it doesn’t look it has spread as far as we know. And then in two weeks I’ll have my prostate taken out with a radical prostatectomy. But here’s an example where this information can indeed be useful, but only in certain circumstances. We’re not suggesting that everybody be screened, but in certain circumstances, this information can interact or work together with already established guidelines.

DR. TUCKSON: Well, thank you very much. And thanks for sharing such a comprehensive range, not only of the technical but the personal, and we very much appreciate that.

When we get to the question period, I’m going to ask you some issues regarding, again, from the consumers perspective, how does the consumer know that the test -- and your test -- do what they say they do? You’ve also opened up the Pandora’s box of the reliability and the interpretation of information which we may get to. But at a very fundamental level, you seem like a nice guy, deCODE seems like a pretty nice company. But again, how does the public know, and is there adequate oversight that says that somebody is checking on you despite the fact that you’re such a lovely person?

Ryan Phelan, founder and CEO of DNA Direct, would you carry this on for us?

MS. PHELAN: I’ll try. Thank you for including me here today. My company, DNA Direct, does a little bit of a different service in the genome-wide arrays that you’ve heard about here today. We actually offer services that we call medical diagnostic tests -- genetic tests that help people make health care and medical decisions.

We’re not the lab; we are genetic experts, we’re comprised of medical geneticists that act as our medical director and guide our clinical protocols, and genetic counselors that interpret and provide information to consumers. I started this company just over four years ago, and so we actually have real on the ground experience talking with consumers, patients, and providers every day.

And I thought what I would do is share with you a little bit about what I’ve learned from our customers. And also, I’m (inaudible) with all these things that I’m thinking about in response to so many of the thoughtful questions raised here today.

Now, I’m going to start with actually something that Rebecca raised, which is, our company does BRCA testing. Now again, we work with Myriad Genetics as our lab, and we help people with that very important decision early on, of whether or not testing is important. I’m going to talk about that a little bit because to me that’s what is involved in, is the testing process reliable? Dr. Gulcher has done a great job talking about the accuracy, the clinical and analytical validity of these tests, which run 99.9 percent molecular diagnostics. But it’s the whole process that I think consumers need greater understanding and awareness of, and in a sense, should actually drive for even a better quality and standards in this industry. So I started the company because I knew people were not getting access to some of the medical genetic tests that I thought were really useful, that medical guidelines were established saying people within a certain protocol with -- where testing would be relevant.

And our company does the same kind of assessment for determining who is appropriate for testing by demonstrating the pros and cons of testing and helping people really make an informed consent. And I believe that that has to be a really important part of any testing process.

So what I have up here on this slide is just a handful of the questions that consumers raise every day. And we know this both from phone calls we’re getting, from emails, and from where people look on the site. So obviously, can I trust this test? Can I trust this company? Will my results be kept private? What is your privacy policy? Will this test actually help me make a better health care decision? Is this test going to be covered by insurance? Will this test give me peace of mind? These are the kinds of questions that consumers have, and that companies have to responsibly provide answers to, with transparency. And I believe that where our industry is going, now that there are even more reputable companies, I believe, coming into the space, is really trying to create some industry guidelines, sort of a best practices. So our company provides full transparency around our policies on our site, and I believe this is going to be an increasing standard that will happen.

You have the next slide? I also think that it’s important here today to talk about this field of genetic testing with a little bit greater distinction. And so I’ve done sort of a sampling of a very crude way of categorizing testing. So on the very bottom, I’ve put down diagnostic testing for very targeted genetic diseases, and I’ve included in that as an example, Huntington disease. And as Jeff mentioned, this is a highly deterministic test, it’s one where people who are carrying the mutation will in fact at some point in their life develop Huntington’s disease. And what I’ve put on the right-hand side are examples of support services that I believe have to be provided in order to offer that testing in a responsible manner. So on the very right- hand side, it says, “in person consultation;” I’m assuming in a physician’s office with health care professionals doing some kind of physical and mental and emotional assessment of this particular patient in order to determine whether or not Huntington’s disease testing would be relevant and useful to them. That’s standard clinical practice, and that’s part of the medical guidelines. But as we move further up the ladder of genetic testing -- and where we’re going today into the consumer world, we’re seeing predictive testing (inaudible) for serious health care conditions, like BRCA.

And probably many of us in this room would debate whether or not BRCA testing needs to be done in a physician’s office face-to-face. Well, the truth is, in major academic centers all over this country, even they are having to often utilize genetic counselors by phone. Some people prefer them -- prefer the phone to a face-to-face, and in addition, it can reach a much greater audience of people with very limited genetic expertise. At DNA Direct we do everything by phone, but we do pre and post-test counseling by phone and by web. So that’s an example of where we’re starting to see a virtual provider actually filling a clinical need. And as we go up the ladder, I’ve got genetic (inaudible) carrier, risk assessment for things like Cystic Fibrosis or for pharmacogenetic testing, for Warfarin, or for Tamoxifen testing. At DNA Direct we do that without a phone consult, per sé, being required but with physician oversight. Those are supposed to be tic boxes by the way, I’ve got to fix that and with web support. And then as we go up that ladder where you see genome-wide testing, I’ve included genome-wide arrays, like some of the companies that we’ve discussed here today -- but also, full gene sequencing. I think that what’s going to happen is there’s going to have to be a different level of support in order to responsibly provide that service. At some point, today we may say that there are, you know, a handful or a dozen tests of SNPs that have clear, clinical implications, but if we fast forward 18 months, 5 years, those tests are going to become more and more predictive and they’re going to have greater and greater weight. And the question is, at what point does that testing require physician involvement, at what point should it require a genetic consult or medical advice, as Rebecca was mentioning -- or a health advocate. At what point are there intermediaries that help some of these consumers: 1) make a decision whether or not testing is going to be helpful and relevant and appropriate to them; and 2) what are they going to do with the information once they get that result, do they have any kind of safety net of people that they can actually to?

DR. TUCKSON: Ryan, before you go on --

MS. PHELAN: Yeah.

DR. TUCKSON: -- before you go on, let me just make sure -- because you mentioned that some of these, you said, should have check --

MS. PHELAN: Yeah. Yeah.

DR. TUCKSON: Are you saying that the --

MS. PHELAN: Those little funny boxes on the right.

DR. TUCKSON: So -- oh. The funny boxes on the right?

MS. PHELAN: The -- those little --

DR. TUCKSON: Okay. So they’re the stars?

MS. PHELAN: The stars were meant to be stars.

DR. TUCKSON: Okay.

MS. PHELAN: That I’m saying are condition dependent.

UNKNOWN: They look like little windows.

MS. PHELAN: And the little windows are --

DR. TUCKSON: Those are checkboxes.

MS. PHELAN: -- or doors were supposed to be checkboxes. Sorry about that.

DR. TUCKSON: Okay. Good. So it’s right in the handout, people have, by the way, over here.

MS. PHELAN: Yeah.

DR. TUCKSON: Good. Keep going.

MS. PHELAN: Okay. So this is kind of a wild leap at -- with really no setup for this. But this is an idea; it’s called DNA Perspectives. It’s a concept that DNA Direct is working on, we’re inviting industry-wide collaboration with non-profits, with academic institutions, and others to actually help consumers identify whether or not a test is going to be useful, responsible, and relevant to them. So this is really a placeholder; we’re starting this around -- just with gathering information from different experts on Alzheimer’s testing. That would be with the APOE gene.

And what you see here is an expert’s rating system. So this would be actually provided -- this information, this score, would be done by a dozen or so medical experts from around the country. Their discussion regarding whether or not they believe the APOE gene has scientific validity, would be completely transparent to anyone who wanted to look on this wiki. And we’re in the process of doing this. So we did a placeholder here in this mockup saying the community could probably agree -- the scientific community -- that APOE gene is highly correlated with the scientific validity for Alzheimer’s. But the predictive value, I’m just -- we’re giving a random 25; it’s probably a lot lower in predicting who will actually ultimately get Alzheimer’s and who will not. And hence, the clinical utility with there being no known therapeutic intervention for Alzheimer’s, would probably be viewed by the scientific and medical community very low. But I show you as an example the personal utility. With a score of 75, if we ask consumers -- and there have been studies called the REVEAL Study that show this -- that consumers would actually say, knowing my predisposition for Alzheimer’s disease would be highly useful to me as a consumer. And what I’m trying to do here is to show that there are going to be services like this, whether or not it’s DNA Perspectives or DNA Perspectives grows and it morphs into something that could be something that the industry actually comes together with, with government and non- profit agencies actually really build an independent ratings system. This is where we have to go because this question about how do you know what one test, one company, one service, one variant -- what’s the real usefulness of it? I think there’s going to be a lot of public debate on this. And I don’t think we can wait and say this all has to be done before anybody does any testing. The testing is happening, information is happening, it’s getting to the consumer. But meanwhile, we need to be able to figure out how can people actually start to look at what experts are saying about this, and then ultimately, how can consumers wade in and provide their own information, their own feedback, on the usefulness of these tests and of the actionability of these tests.

So we’re going to be launching this fall with literally just this one gene variant with our scientific community inviting consumers to participate in this discussion, and I’m really putting this out as a placeholder to people here in this audience who may know of other industry-wide initiatives. People have talked a lot about the need for a ratings system, but I believe that we need to start to make this happen and to see what are the components that are really going to make a difference for the end-user, who is the consumer, the patient, and the provider, I think.

DR. TUCKSON: Well, thank you very much. I’m going to come back and ask you to delve a little bit more -- when we get to the question period -- around those consumers that are on the phone. What are they really saying to you about what level of ease or dis-ease they have about this reliability business and this privacy business. So just know I’m going to come back.

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