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Straight Talk on Direct-to-Consumer Testing With Mygenome s Fred Ledley

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At A Glance

Name: Fred Ledley

Title: Founder and chairman, Mygenome

Background: Founder, CSO, and director of Framingham Genomic Medicine — 1999-2001; President, CEO, and director of Variagenics — 1996-1999; VP research and development of GeneMedicine — 1993-1996; Professor of cell biology and pediatrics and Howard Hughes investigator, Baylor College of Medicine —1983-1995

Education: MD from Georgetown Medical School — 1978; BS in physical science from the University of Maryland, College Park — 1974

Age: 50

 

You founded Mygenome in 2002 to offer predictive genetic tests directly to consumers. How has the business been going?

The company is not up and running yet. The stumbling block at the moment is, we are coming out of a really bad couple of years for investment.

Once you have secured funding, what’s the first thing you want to do?

We think there are probably about a dozen or 20 really good [predictive genetic] tests out there right now. For each one, we would build what we call an instrument, something that will help individuals understand the test, make an informed choice whether to buy it or not, and buy it in privacy. We will have the test done, give them the results, and then help them use that information to make decisions.

We think that scalability is critical. We [want to create] written instruments, electronic instruments, interactive videos, things like this, at the right level and [using] different languages. We will probably hire more educators and genetic counselors than we will doctors. The issue here is quality, reproducibility, getting people in the hands of their doctors with the information. But we think the testing itself is an educational issue.

We also believe we can say ‘no’ to people. If somebody does our quiz and they don’t get the one key question right, we believe it’s going to be really ethically important to say, ‘no, this is complicated, we would like to recommend a doctor you should talk to in your area before you do the test.’

I am not fond of telephone counseling. I don’t think you can train people to do this like you can the Microsoft engineer to figure out how to fix your software. But the data [in the literature] says that the validated instruments, in many fields, can beat the average quality of a general practitioner.

Will you also provide the test?

We want to be an intermediary, we do not want to build laboratories. There are really good labs out there that do very high volume very cheaply. The testing itself, I believe, is a commodity business. We believe the value is in taking good care of customers.

What are those 20 tests you want to start with for?

I think that the Roche [AmpliChip] is a great one. For one of the genes on there, 2D6, there are 200 million prescriptions a year in the US written for drugs that are metabolized by that enzyme. We think Alzheimer’s is a really big one. I think Roche is certainly going to come out with a heart panel in the net couple of years, which should be a great product. Cancer, not so much, actually. That’s the one that everybody wants, there is no question about it. Right now, the tests are a lot more complicated. The one that the genetics community loves is liver failure. As a business proposition, it’s not nearly as big as heart disease or Alzheimer’s, but [it’s] a very common problem.

How large do you estimate the market for direct-to-consumer testing?

There really is no direct-to-consumer [testing] right now. We think the market for predictive testing total is only $200 million. That’s small, given what people thought it would be. But we know that $200 at best represents 5 percent of the available market for the tests that are out there today.

We know about 20 different [market] surveys in the public domain. We are aware that people like Amway have actually done this market research. What we find is, this looks like a really good consumer product. What you find is that somewhere between 30 and 50 percent of the population says they definitely would want to do this. That’s better than any consumer products out there. Our business projections are, if 5 percent of that really happens, it’s still a huge blockbuster business.

So genetic tests only reach 5 percent of the market — what are the main barriers?

The main barrier is that genetic testing is still not intuitive. Everyone understands what a glucose or a cholesterol level means, but people do not understand what a cystic fibrosis carrier mutation means, and that includes doctors. There are not enough genetic specialists, including counselors, in the world just to take care of this one test. So you are asking a generalist, in this case an obstetrician or a gynecologist, to explain genetics to a patient. And in fact, mistakes are being made. It’s unacceptable what’s been done. Obviously, mistakes are made, but in this case, they are simply avoidable mistakes.

The second [barrier] is, physicians don’t really want to do this. Physicians don’t feel comfortable doing this, this isn’t what they are used to doing, they are not trained in it, the information changes very rapidly. You really do have to be up on the literature, and physicians, particularly primary care people who are in the trenches, they just flat out don’t have the time.

The FDA recently approved Roche Diagnostics’ AmpliChip. Roche is now planning to educate doctors about the use of this chip, and genetic testing in general. Will this remove one of the barriers?

The data is, the government has spent $100 million trying to educate physicians already in the use of testing like this, and it’s had no effect whatsoever. I am a physician, I have a lot of respect for physicians, but I believe this is just the wrong approach.

I believe counseling can be done using automated systems and things like that. To simply lower the standards, which is what I believe has happened, I think is a big mistake. Roche will try, I am sure Roche will spend a lot of money. I think it’s a big boost technically because it reduces the price. I think that this will be a difficult test to sell.

Why?

What it does is, it looks for a number of genes involved in drug metabolism. In fact, that’s very important. There are drugs out whose effect clearly can be improved by a test like this. On the other hand, that data is not new. These are oldies but goodies that are now on a chip. [But these tests have] never been used, for a couple of reasons. One is, the companies have worked very hard to avoid labels that discourage use [of their drugs] in particular people, even when it’s dramatic. The data, for example, on warfarin is very dramatic. Most people who have heart attacks are put on warfarin to prevent blood clotting, it’s a classic blood thinner. The other thing it is used for is rat poison. It’s a dangerous drug. The data is very clear that the people with life-threatening events have genetic deficiencies of one of the P450s, and virtually all the people with life-threatening events can be identified through that test. This data has been around for 20 years, the test is very simple, you don’t need a gene chip to do it. It’s not been done. I think until you have product labels that say, ‘the person who has [this] 2D6 deficiency should not take [this drug]’, I think it’s not going to happen.

So you need the cooperation of drug companies to come up with these labels?

That’s one way to do it. The other way, which is my favorite, is, patients will demand it.

We have done a lot of public opinion surveying, and it says that people really want genetic tests, so that they can be smarter about their healthcare. A lot of the stuff that physicians talk about you don’t hear from patients. Doctors say, ‘it has to be a curable disease.’ Well, patients don’t say that. What patients say [is], if it can’t be prevented, they would like to know in advance so they can write a living will, they would like to buy long-term healthcare insurance, they would like to decide when to retire, they would like to get their finances in order, they would like to spend more time with their families.

I strongly believe that the benefits of genomics transcend medicine are bigger than medicine. As long as this is caught in a power struggle with doctors, a lot of the benefits are not going to be realized.

Have you taken any predictive genetic tests yourself?

Yeah, but that’s private. I think [privacy] is a bigger issue than most people think. Not job discrimination and insurance, you can pass laws to prevent that, [but] the biggest issues are social and personal.

 

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