This year, I was given a six month contract to work as a consultant medical science liaison at Myriad Genetics. I must admit, I was apprehensive; Myriad has a contentious reputation, especially amongst the genetic counseling community in North America. This is mainly due to Myriad's involvement in the patenting of the BRCA genes in the USA and Myriad's decision to not submit data to ClinVar unlike most other genetic testing laboratories. It is not uncommon for contractors to feel as though they are not treated as well as employees and unfortunately this was my experience at Myriad. It surprised me, as a genetic counselor and knowing Myriad's own subpar reputation, I thought my experience would be positive, however this was not the case. Although not unique to Myriad, I witnessed low morale, staff layoffs, restructuring, and staff concerned for their ongoing employment. Communication between departments was lacking and nonchalance and apathy abounded. The good news is Myriad has lots of room for improvement and I truly believe they can be leaders in genetic medicine and lead with integrity.
Myriad Genetics has a suite of fantastic, industry leading genetic tests, that help thousands of people each month. However, a lab is more than it's tests. Cultural change is needed. One bright star at Myriad is genetic counselor Susan Manley, the Senior Vice President of Medical Services.
Join us as we uncover Myriad's evolving stance on ClinVar, a public database for genetic variant information. From initial reluctance to eventual contribution, discover the driving forces behind this monumental decision. Learn about the challenges faced by Myriad, the strategies used to reclassify variants, and the complexities they grapple with when explaining uncertain results to patients. As we wrap up, Susan offers her forward-looking views on the future of genetic medicine, leaving us with plenty to ponder. Embark on this enlightening exploration with us, and prepare to see genetic medicine through a new lens.
This year, I was given a six month contract to work as a consultant medical science liaison at Myriad Genetics. I must admit, I was apprehensive; Myriad has a contentious reputation, especially amongst the genetic counseling community in North America. This is mainly due to Myriad's involvement in the patenting of the BRCA genes in the USA and Myriad's decision to not submit data to ClinVar unlike most other genetic testing laboratories. It is not uncommon for contractors to feel as though they are not treated as well as employees and unfortunately this was my experience at Myriad. It surprised me, as a genetic counselor and knowing Myriad's own subpar reputation, I thought my experience would be positive, however this was not the case. Although not unique to Myriad, I witnessed low morale, staff layoffs, restructuring, and staff concerned for their ongoing employment. Communication between departments was lacking and nonchalance and apathy abounded. The good news is Myriad has lots of room for improvement and I truly believe they can be leaders in genetic medicine and lead with integrity.
Myriad Genetics has a suite of fantastic, industry leading genetic tests, that help thousands of people each month. However, a lab is more than it's tests. Cultural change is needed. One bright star at Myriad is genetic counselor Susan Manley, the Senior Vice President of Medical Services.
Join us as we uncover Myriad's evolving stance on ClinVar, a public database for genetic variant information. From initial reluctance to eventual contribution, discover the driving forces behind this monumental decision. Learn about the challenges faced by Myriad, the strategies used to reclassify variants, and the complexities they grapple with when explaining uncertain results to patients. As we wrap up, Susan offers her forward-looking views on the future of genetic medicine, leaving us with plenty to ponder. Embark on this enlightening exploration with us, and prepare to see genetic medicine through a new lens.
Hi and welcome to Demystifying Genetics. My name is Matt Burgess and today on the show I speak to Susan Manley, who is the senior vice president of medical services. We speak about some controversial things relating to Myriad, the company that she works for, namely the Bracka one and two patenting issue that occurred in the last decade or so, and also we talk about Myriad's involvement with ClinVar. So, susan, welcome to Demystifying Genetics.
Susan Manley:Thanks, matt, I appreciate being here.
Matt Burgess:So where in the world are you today?
Susan Manley:Salt Lake City, Utah.
Matt Burgess:Okay, I've been to Salt Lake City once, when the NSGC conference was a few years ago. It was sort of the last year before COVID and the world went crazy. Oh, is Salt Lake City considered the desert?
Susan Manley:It's a high desert. It's not quite as desert-y as Phoenix or other places, even in Utah, but it's definitely desert-like. It'll be 100 degrees today. We always have water conservation issues happening here in Utah. In fact, most of our water we get from snow. In the winter it rains very little. In the summer the sun's always out. It's super hot, very dry, definitely desert-like.
Matt Burgess:It was crazy. I remember I went to the gym and I was all hot and sweaty and was working out and I could see the snow up on the mountains and I thought, wow, I've never had that before.
Susan Manley:You wished you were there. Right, the mountains are very beautiful. It makes those 100 degree days worth it.
Matt Burgess:Yes, Now I should just explain how this podcast came about. So a few months ago I was lucky enough to get a six-month contract with Myriad. So I'm a genetic counsellor and I was working in women's health in the Women's Health Division as a medical science liaison, with a team of a lot of other genetic counsellors, and during my first week you were lovely enough to offer a virtual coffee, which I accepted. And I must admit I was a little bit apprehensive about joining Myriad, and it was really because of two main things and I think there are probably other genetic counsellors out in the community that have an issue with these two things as well and the conversation I had with you was amazing and I just thought maybe we could have a podcast and talk about those things.
Susan Manley:Yes, I appreciate again the opportunity to do that, and we have about 120 genetic counsellors who work here at Myriad. We have a really lovely community of GCs from all different parts of the country and when I see new faces I always reach out and try to welcome them into our Myriad community. And it's true, Many people have feelings about Myriad or thoughts about Myriad, or have had to really think about what they want personally or in their career before they decide to come to Myriad. So I really I too, enjoyed the conversation that we had.
Matt Burgess:Well, thank you, thanks again. So I guess, before we get to that, how long have you actually worked at Myriad?
Susan Manley:27 years, wow, but I started when I was 12. Excellent, so I was a child prodigy. You can do that math right there. No, I did come right out of graduate school and I joined Myriad about eight months before the commercial launch of BRCA one and two testing. So I've kind of been here the whole time through this whole journey that we've been on, not just Myriad but, I think, the genetic counseling profession and the medical community and the molecular diagnostics industry. You know, it's really it's been a 27 year journey, I think, for all of us. So, yeah, I've had a multiple, multiple different roles in that time that I've been at Myriad, but I've been at Myriad for my whole career. Oh, wow.
Matt Burgess:And when you were at grad school, did you think that you would go in into industry? And did you think if you went into industry, you would be in the same position for nearly 30 years?
Susan Manley:So to the latter question no, I think you know, and I give that advice to students all the time. You know, just don't think you're going to nail it the first job you get, because you don't know what you love or don't love and you're going to change. And I happened to be very lucky that I joined Myriad at the time. That I did and I was allowed the opportunity to grow and evolve and change as Myriad did, and I had a lot of opportunity to do different things. But you know, 27 years ago there weren't industry roles, that wasn't really a thing. There were a very small number of genetic counselors who provided laboratory support for labs like LabCorp, cos, genzine back then was a thing and there were many genetic counselors who were employed by labs to provide genetic counseling to patients, which happens kind of now as that kind of patient education offering that some labs have. But that wasn't really a career choice that you thought about. Right, it was mostly back then. Cancer was even emerging. You know it was basically you were prenatal or pediatrics and so, yeah, all of that has really grown and developed and I wish I could say I had this grand design for my career and I did not.
Susan Manley:I worked hard, I was lucky, I was really open to whatever opportunities came my way. I was willing to do different things and, you know, mostly I just kind of evaluated things, thinking about two things. You know one who am I working with? The people that I'm working with? I have to really like the people, as I think we all do. I have to love the people that I'm working with, because otherwise it's just not fun. And how can I really help patients?
Susan Manley:Right, we all go to genetic counseling programs wanting to help patients, but realizing you can do that in so many different ways, and so the opportunity to work with a company and help them help so many patients and help my colleagues help patients was really appealing to me. So, no, I didn't have a strong desire to go to myriad. They were hiring when I was looking and I came out and had an interview and just loved the people and was really excited about what they were doing, because 27 years ago there weren't commercial diagnostic labs really doing this. They were large labs that had genetics offerings and I at the time thought, wow, good for them, for knowing that they were going to go into this sort of new industry and do something different and wanting to have a genetic counselor at the table, as they did that. Yeah, I just thought it was a really great opportunity.
Matt Burgess:Yeah, that's cool Having a genetic counselor that's sort of involved in the conversation and leading, because that definitely doesn't always happen. But I guess that leads into the first sort of controversial issue, so, and that's of the BRCA patent. So I guess you know, when people think about myriad and they think about BRCA testing, you know myriad was involved with patenting or trying to patent a gene and I don't even really know where to start. But yeah, can you tell us a little bit about I don't know like sort of superficially or as a layperson, if you don't know much about it, you kind of think, patenting a gene? That sounds ridiculous. How can you do that? Yeah, how did you do that?
Susan Manley:Well, being a genetic counselor at Myriad, I wasn't hands-on involved with the patenting of whatever intellectual property things we patented, but certainly as I worked with others and other healthcare practitioners and other genetic counselors, it became an issue and certainly when the patents were reviewed and overruled by the Supreme Court it was really all anybody ever wanted to talk about.
Susan Manley:But my understanding is that Myriad held a number of gene patents on both BRCA1 and BRCA2 dozens perhaps of different kinds, and the patents that were under dispute and ultimately overturned were patents on product of nature. How could you just go into the forest and find a tree and patent that tree? That's kind of what the example is. We had those kind of I think they were called composition of matter patents, products of nature patents. We had some patents like that but other patents as well. But I think those products of nature patents were seemingly the most comprehensive and the most powerful for protection of intellectual property. It's also my understanding that hundreds of genes had these patents on them and that the number one patent holder of this type on genetic material or genes was actually the NIH. So it was commonplace to clone, be credited with the discovery of a gene, if you will and then the legal team would just file a number of patents. It was just very commonplace to happen.
Matt Burgess:I guess when you discover something called, you first describe it, normally to claim that, so to speak, you publish it, and I guess that's what you just said. But on top of that it sounds like the legal team followed up with a patent that came on top of that. Was it more than just acknowledgement of who first put this together, or was it the aim to actually stop other people using that information?
Susan Manley:Yeah, I think that's where the story gets frustrating for many, which is whether you're the NIH and you're filing patents on the cystic fibrosis gene or you're myriad of filing patents on BRCA one and two, the patent office may grant you legally these kinds of protections, but it's whether or not you enforce them. And myriad being born out of the fact that we can do this faster, maybe better make it a commercial thing, make it more accessible to more patients really had a very vested interest in the commercial opportunities for BRCA one and two, and so, as other labs started offering BRCA one and two testing, myriad sent letters saying we actually have broad patent protection over commercial gain for doing the testing for these genes and we're asking you to stop doing that. So I think that's what was different than maybe other academic institutions or our government that had patents on other genes. They weren't enforcing that intellectual property where myriad was, and I think that's where the people went.
Susan Manley:Hmm, this could be very bad for many people and many patients. If you can discover something that naturally exists, make a claim to it and prevent other people from doing it. But I think oh, I'm biased. I just told you I worked at myriad for 27 years. But I really feel like at that time there was not mal intent, it was. This is how it works you discover something, you patent it and then you enforce that intellectual property protection, just like Thermo Fisher did with PCR technology, and it seemed like this is kind of how this industry works.
Matt Burgess:Yeah, I'm trying to remember back because I was practicing genetic counseling in Australia at the time and I wish I could remember better. But I think that there was one lab in Australia that sort of had permission from myriad like they were licensed to do the testing. I'm pretty sure that there were other labs that were doing testing and the attitude was well, they can come and stop us, so they can sue us. And I think that that's how it was. Yeah.
Susan Manley:I do think that myriad had different strategies in the United States because we were only a domestic laboratory at that time. So whatever was happening in Australia or in Europe or wherever and I do think that the US Patent Office may not extend the same kind of protections outside of the US. So I think once you talk about the international stage, it gets probably more complicated. And again, I believe that myriad didn't want to prevent people from getting information or stop people from learning about these genes. Myriad was hoping to have commercial success by offering testing for these genes. So whatever was happening in Australia was probably not a threat to any of those things that I just described in the US.
Matt Burgess:Excellent. And then what happened?
Susan Manley:Well, it was frustrating for a lot of people. I think that there were some labs who felt like, well, we should be able to get commercial gain from this as well. You didn't invent a technique or a specific product, so why can't I do BRCA testing? In ChargeFord too? There was a lot of frustration there.
Susan Manley:I think some people inadvertently thought that patent protection applied to any testing of those genes, any sequencing of those genes. My understanding is that the patent protected intellectual property and commercial gain. That's why you do it right. You do it because you want to hold on to that commercial gain. So if people wanted to test all day long and sequence these genes all day long, which they did there's hundreds to thousands of research papers published on BRCA 1 and 2, even during the time that you had patent protection, those protections didn't apply to research environments or they didn't apply to places where they were doing testing without charging patients.
Susan Manley:But the narrative just got really heavy. How can one company own all of this? It just doesn't seem right. So I said this back then like this is an interesting conversation and an interesting conversation that has to be held within legal expertise. Right? This is a legal issue, not necessarily a clinical one. It started locally but then was elevated all the way to the Supreme Court this idea of can gene patents exist on products found in nature. I always felt like that was a great thing to have happen at the Supreme Court level.
Susan Manley:Let's hear it, debate it, understand it, rule on it and then everyone can move forward. Because I think the whole industry was anxiously looking at this to think about. What does this mean? Again, I think from the clinical side, the hope was more labs, testing, more availability, cheaper prices, all of those things. But the industry was watching too, like okay, so what does this mean? If you can have gene patents on specific genes and we have gene panels today that are 10, 20 genes, what about when we go to 100 gene panels? Or if whole genome? Are we going to have to be paying royalties to the discoverers of every single individual gene that we're testing? As soon as anyone started thinking like that, it became clear that that's not tenable and that's not good for medicine. Having it go to the Supreme Court really it was challenging for myriad Myriad was the narrative around. That was myriad owns your genes. You should be very upset about that.
Matt Burgess:Yeah.
Susan Manley:Of course, it was breast cancer, which has a very passionate advocacy base, and so people thinking like I can't get genetic testing unless I go to Myriad to get it. It really became a very large hot issue. And then the decision came, and then everything changed, I think for the better, and I think our leadership at Myriad would say too like patents on products of nature were legal, but it makes sense that they're not, and there's other ways to protect your intellectual property. There's other ways to do patents around genetic discoveries and genetic technologies, but these, isolating a product of nature and claiming a patent on it was probably the right decision, and to have it elevated to the Supreme Court and heard in that manner, so that we can all move forward with clarity, was a good thing, I think, for our medical society.
Matt Burgess:Yeah, I agree. Back in season one of Demystifying Genetics I had genetic counselor Ellen Matloth on.
Susan Manley:Yes, I know Ellen very well.
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Matt Burgess:So, moving on to the second issue that I wanted to talk to you today is ClinVar. Now, clinvar is a publicly accessible database that's hosted on the internet and it has all of different variants that have been discovered for different genes, and I guess the idea is that labs from all over the world can contribute information to this database and anyone can use it to help with resulting genetic tests. Now Miriad has been a lab that was doing testing for many, many, many years and had a lot of data but was not contributing to ClinVar and I think that in the genetic counseling community especially, that really rubbed people the wrong way. Now do you know why that was the case and how come it changed a little while ago?
Susan Manley:I do and I've sort of been a spectator and participant in this particular issue the legal issues. I was sort of on the side and watching everything play out, like everyone else. But this issue was a little closer to home, being involved in the clinical development and launch of BRCA 1 and 2 testing On the very early days, like in the mid to late 90s. There was a database before ClinVar which was called BIC, the Breast Cancer Information Core, and it was largely similar in concept to ClinVar but was focused solely on BRCA one and two because, honestly, that's really all there was back then. From the beginning we were contributors to BIC and other labs were true, other research labs right, all of the labs we were working with to launch the product, other competitor research labs. Our experience with BIC was less than ideal because it just was not updated very quickly. It was not updated as frequently as we would like. Sometimes the updates had errors in them Back in the mid-90s, database architecture and the data itself was just messier and worse. As Miriam put our name out there, as we're the ones we do this, we're doing it at a high quality. We know a lot. We had a very frustrating experience with that breast cancer information core, not because anyone had malintent, but just the rigors of data infrastructure and architecture and updating and government funding. It was not an ideal mechanism that we felt made Miriam look good. We were changing our database daily and it was very hard for BIC to keep up. We made the decision to withdraw from that database initially for these kinds of reasons, just never.
Susan Manley:When ClinVar came out, I think our reaction was well, we've done that. We haven't had the best experience with that. I don't think we're going to do that either Up until the patent issue and I don't know the timing of when ClinVar started or when it really got really going. But I think after the patent issue it became a much bigger deal because other labs were now doing testing and we had already had a decade of experience and there was a lot of pressure for us to put variants in ClinVar and Miriam's past experience with database the fact that our database is literally changing daily.
Susan Manley:We were not very excited about the pressure to contribute to ClinVar and we tried to contribute in other ways. We did a number of publications. We would share data sets with researchers to publish things. We published a number of papers about unusual variants that were in special classification categories and, of course. But it's slow, right, and once you publish something you don't always update that or follow on to that story. It's kind of a you know you either publish something about a variant or you don't, where a database is kind of breathing living, ongoing, and so there continued to be a lot of pressure for us to contribute to ClinVar.
Susan Manley:But then, you know, after the patent issue was overturned, there was suddenly a lot of competitors in that space and, of course, commercially. That made it even less interesting for Miriam to want to put a lot of information into ClinVar, feeling like we've worked very hard to do good science for a decade and we want to continue to do that good science and use our money for innovation and continuing to learn, versus putting all of this information out in the public domain. And it was very unpopular, as you know, as everyone listening to this podcast knows as well, and it felt like, I think, a lot of people. The narrative was well, the patents were overturned, so now they're going to hoard their information. And it wasn't because of the patent we were hoarding information.
Susan Manley:We had experience with public databases early on. That made us very leery of putting data into the public domain and being seen as the experts on these genes. Our database changed every day. Literally every day our database changed. How could a public database keep up with that? Would it reflect poorly on myriad? How long would it take us to update a classification at myriad? How long would it be that it would be reflected in a public database? All of these things became very concerning. For a long time we were against contributing to ClinVar.
Susan Manley:Myriad has changed a lot over the years. The whole industry has changed a lot over the years. We had new leadership moving into the pandemic, the opportunity with a new CEO. They always ask questions that we all have thought we've known the answers for a long time. He started asking these questions like why don't we put data in ClinVar? He started this whole journey himself like why don't we do this? What's the downside? Why should we do this? What is it like? It took him, our new CEO it took him a long time to really think through this and learn about it and hear from a lot of different stakeholders. Ultimately, we were all in discussions and came to the conclusion that it's really better to share the data. Some of the constraints that we had in the past the data wasn't updated frequently enough or these VUSs we were changing all the time. Some of those issues were resolved. Some of those issues have gotten better with technology over time.
Susan Manley:Our new leadership asked us to really think about a way that we can contribute meaningfully to ClinVar. People at Myriad were very happy about this outcome very happy, really excited, to be able to share with people in a different way. As I mentioned, we had publications. If people would call us, we would share certain pieces of information. To just have it out with everyone else in ClinVar was a really exciting time for many of us at Myriad.
Susan Manley:This year we actually started contributing variants to ClinVar. It's a little slow for us at first because the data has to be packaged in such a way. We want to make sure we're doing it in the right way. We've got variants that we've seen 25 years ago. They're not informatically packaged the way that ClinVar wants to receive them. We had to think about the work we would have to do to put things in ClinVar Conceptually. Our new leader was like let's contribute to this. We need to be part of the solution. We need to help others. This is all great. We should move forward and be a good steward of our information by sharing it with the scientific community.
Matt Burgess:Yeah, okay, that makes sense Idealistically. Having a free database, I think, is a good idea. It is good for humanity or for genetics and nature and all of that kind of thing. I think you really highlighted the issues with the free database, that kind of concept of garbage in, garbage out. Anyone can submit or upload anything. Is there consistency in nomenclature or syntax? If different labs do it different ways, there's no lack of consistency. Okay, maybe it does make sense that you guys wanted to control the information that you had. Yeah, I guess it's interesting.
Susan Manley:Yeah, Time changes a lot Time, and the landscape of medicine and competition among laboratories. That changes over time too. Our leadership now is very much a believer in improving healthcare for everyone. There's a variety of ways to go about doing that, and sharing data and being a part of that community is one of many ways that we can do that. We obviously have issues like it's. You know it's not like you log into your computer and push a button and that variant goes to ClinVar.
Susan Manley:You know it's. Thankfully it's more than that, because ClinVar is a robust database, a rich source of data. So even just thinking about how do we get that variant we saw 25 years ago right In shape to go into a public database just informatically right, I mean there were kind of work issues that we had to really go through to figure out how we could do this. It wasn't like you're pushing a button and the whole database goes into ClinVar. It's as I'm sure the whole audience can appreciate it. It's a little more complicated than that. So you know, I think we got the approval to work on this and think about what might be best and the opportunity to work with the scientists at ClinVar. And you know we've had, I think, two submissions so far but are committed to ongoing submissions and working with the broader community at large to have good information in that database. So it's really exciting.
Matt Burgess:Yeah, okay, and I see, a number of years ago, back in 2017, you published a paper with some colleagues from Myriad and you know, I do think it's a good idea that Myriad is contributing to ClinVar, but you weren't back then.
Matt Burgess:But I think the paper sort of highlights some really interesting things, and that's just when there's discordant results. So and I mean, it's not necessarily a ClinVar thing we see this with different labs. So really, what I'm talking about is when one lab says a genetic change is disease causing and another lab says that it's not. And just working with families that are having genetic counseling and testing with different labs, you know this is a nightmare and I think you know before I was a genetic counselor, I thought it was really black and white. You know, like you issue a result, it's set in stone, it's right or wrong, it's yes or no and really, like now I'm on the other side, it's like, oh, there's so much gray area and it's kind of a consensus and unfortunately, sometimes labs get it wrong and they try their best. But yeah, it's complicated.
Susan Manley:Well, and you know wrong I'm using air quotes here wrong. You know, calling something uncertain isn't necessarily wrong if you haven't identified the piece of evidence that tells you otherwise right. And you know, at Myriad we have even with patent protection and being the only lab doing this testing, we developed a number of tools that help us reclassify variants. And we've developed those tools that specifically look at our database and are equipped to look at quirkiness in our database. Or we've calibrated them to account for when guidelines changed. And you know average age of breast cancer onset got earlier.
Susan Manley:And so you know we've been able to work within our own system to develop these tools to reclassify variants. But you know it's a very hard thing to do to take something that's uncertain and be able to study it long enough and with enough pieces of data and with enough patients to be able to reclassify it. So you know that tool contributed to our earlier uncomfortableness and contributing to databases is, you know we've got stuff that is anybody even gonna believe what we put in this database and how are they gonna validate it, and you know just kind of all these concerns. But there's a lot of interesting work that can be done and it is interesting because now that so germline kind of paved this path, but now when you go to somatic they're things like that aren't even reported.
Matt Burgess:Yeah.
Susan Manley:Wow, and of course it's different. I mean of course it's different, but you know we not necessarily myriad, but the whole germline hereditary cancer susceptibility feel kind of built this well, we're uncertain today, but we'll know more tomorrow and just really created this thing. That is, it's hard for patients, right, Uncertainty like this is hard for patients. It causes recontact issues for healthcare providers. You know, it's just a whole, it's a whole thing.
Matt Burgess:Yeah, so explaining a variant of uncertain significance to a patient is not my favorite thing to be doing in a genetic counseling consult, but you know it's definitely necessary. Do you think you'll be working at myriad in another 27 years?
Susan Manley:Well, I personally hope to be retired before another 20, although I did. Did I say I started working when I was 12? Maybe I gave myself away? No, um, you know it's so hard to look that far into the future. It's so hard. Our industry and our field is changing so fast and there's so many great ideas and ways to leverage data and ways to do things. You know, I'm hoping for another 10. And I think the landscape will be totally different even within the next decade, just as it was in from the past two decades. So that's a hard question to answer.
Matt Burgess:Susan Manley, thank you so much for your time today. I've really enjoyed our chat.
Susan Manley:Thanks for having me. I've enjoyed our chat too.
Matt Burgess:Excellent, thank you, bye-bye, bye. Thanks for listening everybody. I'd like to thank Susan for being a great guest on the show today. I'd also like to thank sponsor TrackGene and my producer Omi.