Traditional models of clinical translation of genetic therapies have focused on metrics of safety, efficacy and cost. However, wide disparities in the use and benefits of genetic medicine suggest that these metrics have not been successful in guiding equitable translation. This presentation proposes a fourth metric and presents examples of how it can be operationalized.
Center for Individualized Medicine (CIM) Grand Rounds
MAIN PRESENTER
Megan A. Allyse, Ph.D .
Good afternoon. Welcome to our grand rounds. My name is Mia Kiss and I'm the Center for Individualized Medicine Education Director. Really excited to join you here on the Florida campus and to introduce our speaker today. As a reminder, our lecture series is designed to highlight two main objectives. Showcase the latest in scientific discovery and innovation and demonstrate how individualized medicine can be translated into practice to meet current and future patient needs. It's my absolute pleasure to introduce today's presenter, Doctor Megan Elise. Doctor Elise is an Associate Professor of Biomedical Ethics in the Biomedical ethics Research Program and she's also an associate consultant in quantitative health science with a joint appointment in obstetrics and gynecology. Her research focuses on the translation of emerging medical technology from research endeavors into clinical practice, particular interest around reproductive health ethics and women's health and health disparities and access to care. Her previous research work examined the intersection of assisted reproductive care with embryonic stem cell and human cloning research and management of oocyte exchanges. And more recently, she's developed a portfolio around the clinical translation of innovative uh noninvasive prenatal genetic screening, including informed consent, patient education, a stigma in the disability community and understanding the impact of prenatal genomic information on patient care and the experience of pregnancy. She's also uh interested and has uh uh great work in the area of um providing high level care regardless of socio-economic status. And in fact, today's talk will highlight to us how traditional models of clinical translation of genetic therapies have focused on metrics of safety efficacy and cost. Uh However, there's a wide disparity in the use and benefits of genetic medicine using these metrics. And she'll be proposing to us 1/4 metric and showcase how it can be operationalized to uh increase accessibility um to all individuals. So without further ado, please join me in welcoming Doctor Elise as she presents on the translational justice and health disparities research in genomics. Thank you all for coming today. I'm uh happy to be sharing this new concept uh that we've been working on developing. I am gonna apologize in advance whatever respiratory disasters going around has found me. So I will try not to cough during this presentation if I make no guarantees. Um Just to start off, I, I have no disclosures. So I wanna start off by uh outline what we mean by translation. So I think that for some of us translational medicine is a sort of a given thing that we all do but not necessarily everybody. So when we say translation, we generally mean the process by which we get from something that's been discovered in a bench lab or a wet lab. And that is uh moved through a series of about foundation procedures until it becomes uh clinical medicine and then it ends up in the patient. So when I say translation, uh during this talk, that's what I'm referring to is how do we go from biological or chemical discoveries into things that actually touch patients in the clinic. So as we all know, um especially in this day and age, clinical translation is governed by three principles, safety FC and cost effectiveness. And historically, uh if you met all of these three criteria through very rigorous clinical trials or other forms of validation measures, you were considered to have the gold standard. However, if you look at what things look like out in the world, it's not clear that these three principles are doing the work that they say we say they're doing right. So this is a quote from a woman who gave birth during COVID. And she's talking about the fact that because the COVID-19 vaccines, the clinical trials that validated them specifically excluded pregnant and lactating individuals, which is not uncommon from clinical trials. The result was that a wide variety of pregnant women that we spoke to during the COVID-19 uh pandemic were unwilling to become vaccinated because they said there was no safety data available for them. So they didn't know the impact of their uh of the vaccine on their pregnancy ergo they declined to get vaccinated. Now, as we later found out, uh COVID-19 is very dangerous for pregnancy. It has significant impacts on the possibility of preterm birth. And so we should have been vaccinated pregnant women, uh which have been making a concerted effort in fact, to vaccinate pregnant women, but because they were excluded from the child, we didn't have safety data if you look at efficacy. Uh It's not entirely clear what efficacy has come to mean. So if you look on the CDC website, they will say very clearly that many of the therapies that we have available today were not researched in the population that they're actually designed to be used in. So the vast majority of clinical trials are uh include almost exclusively, not almost exclusively predominantly uh individuals of European background and many of them are largely skewed towards uh male uh gender because of the exclusion of reproductive age women. It should be pointed out that not only are pre currently pregnant individuals excluded from most trials, most trials will also require some form of birth control for any participant who wants to participate uh and multiple pregnancy tests. And so that's a descent for people, women of reproductive age to participate in clinical research. So we have a large body of research that is based in European descent males, but is therefore unknown about its efficacy in other populations. And so this is a woman that spoke with us as one of our trials. Uh and she's a black woman and she has had breast cancer. And one of the things she expressed frustration was that the genetic testing um that her family was offered was not specific to uh black women. And that, you know, there are different mutations in black women. We know that they have a higher instance of triple negative breast cancer for instance. Uh And so if we don't do the research in the population, we're trying to help. Can we really say that we've met this threshold of efficacy? And finally, cost effectiveness? I think cost effectiveness uh is measured as willingness to pay per quality adjusted life year or some other standard that you've used. Um But it's not really clear that this applies, especially in the US system in which we don't have a centralized payer who's invested in, for instance, preventative health because of future cost savings later down the line. And so the question of cost effectiveness is actually very um contingent on the socio and political setting in which you are trying to implement this standard of care. So this is a woman um again, pregnant during COVID um different cohort, this is a, a low income uh Black and Latina cohort. And uh the interviewer is asking her how much she would be willing to pay for cell free DNA testing of the fetus uh which tests for Down syndrome tri toy 1318 XY variations. And she said the most she could pay is $50. And that's only because she gets a child tax credit. That credit, by the way, was COVID specific. Uh I believe. Um, and so may no longer be available, but it's worth noting that the minimal billable reimbursement for this CF DNA test is $250. So when we say cost effective, I think we have to ask ourselves cost effective uh in what context and, and for whom? So all of this leads us to question or at least leads me to question whether safety icy and cost effectiveness really add up to the gold standard of translational success that we think they do. And the answer in the US is pretty clearly no. Uh because it becomes pretty clear that safety accuracy and cost effectiveness as a standard um are insufficient to help medicine meet its moral obligations. And I in saying that I am asserting that justice is a moral allegation of medicine. We can have that conversation, but we can see that because our health care system demonstrates so many disparities and such wide differences in health status, health care, access and morbidity and mortality between different groups. It is clear that the standard of justice is not being met. So we would like to suggest that rather than only and not instead of, but rather than only uh safety of exceeding cost effectiveness, we need to attend to some principle of justice when translating genetic technologies or any technology uh from scientific knowledge into medical care. And so we define uh translational justice as procedural and outcomes based attention to how clinical technologies move from bench to bedside in a manner that equitably addresses the values and practical needs of affected stakeholders with attention to the needs the most morally impacted. So what we mean by that basically is that when we are conceiving of a translational pathway starting as early as possible, as far back as when we are making that hypothesis in the lab all the way through the process to the end of dissemination and evaluation. We need to be thinking about who is this for? Where is it going to be used? How can it be used best for the most people in that setting rather than getting to the end of the translational pathway, realizing that there are going to be inequalities and then trying to retroactively address them because as we have seen based on the level of disparities in this country that's not working. So I'm gonna give you a couple of examples of uh how our group has been uh operational these kinds of concepts. So the first is in hereditary breast and ovarian cancer. Um As I've mentioned, there are differences um between white and black populations with um hereditary breast and ovarian cancer. So, if you're not familiar with hereditary breast and ovarian cancer, uh it is a heritable form of several mutations. The one that most people are aware of is BRCA one and BRCA two. and it relies on what we call um cascade screening. So basically, if we have an affected individual, we test them, it is shown to be a germline mutation, we would then recommend testing all of their uh first order relatives. Uh because it's possible that they have also uh inherited the mutation. If we can do that, if we can catch people before we know that they become symptomatic. Uh We have seen in the literature that pre diagnostic awareness allows us to begin screening earlier via MRI rather than just mammogram. The earlier we diagnose any form of breast and ovarian cancer. The obviously better our outcomes are the more likely we are to be able to clear it surgically. And so HBO C, when we're looking at cost effectiveness, uh is estimated to generate 75 fewer mortality cases and 288 adjusted life years per 100,000 women. So, from a health systems perspective, from a health perspective, uh this kind of screening it can be highly effective in reducing overall morbidity. And that is why AC CM the National uh Cancer Collective Network recommends that we should be testing um susceptibility genes in any individual with a blood relative with a known or likely pathogenic variant in a cancer susceptibility gene. And that is why uh most of us, if not, all of us have been asked to fill out a form like this on the left at some point in our medical journey, generally, when you're coming to your primary care physician, of all of the relatives that you have that have uh ever experienced cancer. And what kind of cancer? So again, this is uh the sort of principle of cascade screening is that you have an affected individual, you test all of the family members and all of the family members who find mutations in them that might be suggestive of an increased risk of cancer. However, uh we do see that there are again significant disparities. Black women with breast and ovarian cancer have lower survival rates. They tend to be diagnosed later in the diagnosis or in the disease progress. They experience more delays in treatment and they are significantly underrepresented in clinical trials of novel therapies for hereditary breast and ovarian cancer. They are also less likely to be see to receive genetic testing to understand their personal, increased or decreased risk of hereditary cancer. So, we were asked by a group called the Coalition of Blacks Against breast Cancer, which is founded by Doctor Michelle Hallard and Marian Kelly out of the Mayo Arizona site. Uh And we put together with some funding from the uh breast cancer score at Mayo Clinic Cancer Center to put together the advanced study and basically what the goal of the advanced study was to understand if there are barriers to genetic testing. Um among black women with personal history or family history of breast and ovarian cancer and how those barriers might be overcome. So I'm just gonna give you some stats for a minute. This is the cohort um that was eventually recruited. We did have a first cohort which was recruited largely through the Divine nine and uh traditionally black sororities, the second cohort was recruited in a general population Medicaid clinic. So a much lower um socio-economic status and and income level. So here are some of the things that we learned. Uh We learned that in these communities, there is a significant taboo about discussing health information and especially cancer. So this is an individual who was eventually diagnosed with cancer at 55. So obviously, was it significant increased risk? She's talking about the fact that she didn't even know that she had a family history of breast cancer until she got cancer and disclosed that to her family. And then they responded to say, oh yes, your relatives have also had cancer. So this obviously raises a problem because if you're not discussing family history, then that form that you filled out in the doctor's office is not very helpful to anybody because you don't know that you do actually have a first degree relative who has had cancer. Uh And this is another quote from an individual in the second cohort uh just talking about how her family never shared medical history. Uh And that the attitude was very much one of, don't ask, don't tell when we asked about perceptions of genetic testing. Uh This is a, a woman who is his daughter who uh an aunt and a mother with breast cancer at age 42. Uh She thought, when you say genetic testing, she thought about Angelina Jolie, which is a very high profile case, obviously. Uh And then she said, I thought about it as a celebrity thing, not something that somebody like me would get. Um I never hear about black women who've had genetic testing. And she said, I'm the only black person I know who has had genetic testing. And then finally, we had asked them about their knowledge of genetic testing for HBO C and whether they would be willing to do it. And in fact, we heard that most of the participants we spoke with once it was uh introduced as a blood test, not as a particularly invasive test. Uh so that they actually would be very likely um to, to accept genetic testing if it was offered to them and that they didn't see any significant barrier uh to doing that. And so what we learned from all of this was, I think there was uh this qualitative research which is not hypothesis driven. But if you looked at the sort of general uh zeitgeist in the literature, there was a lot of uh literature about trust. So black people don't trust genetics, they don't want genetic testing because they don't trust. Um And what we found was actually not that uh what we found that the reason, the most likely reason that we were seeing a lack of uptake of genetic testing was a lack of knowledge of family history, which meant that they didn't know they were eligible for genetic testing and also just not being authored it. We had several women say nobody's ever asked me if I wanted genetic testing. So this is really when we think about how do we uh focus on the translational justice of hereditary breast and ovarian cancer, we are seeing a disparity. It's not the cause by what we thought it was caused by, it's caused by something else. And so when we look at intervening, uh we are trying to target what our qualitative research tells us is the actual appropriate target here, which is knowledge of family history and not necessarily comfort with genetic testing or awareness of genetic testing or heredity. So the, this is a trial that uh we uh submitted to NC I. Um it has not been funded at the moment. Uh But it's basically a two part um intervention, one which is an awareness campaign uh to help families understand that the more conversations they have about history, the more conversations they have about the possibility of somebody inheriting cancer that there are concrete health benefits to that. And one of the things we did hear from a lot of women, especially older women was that they do experience that taboo, that reluctance to talk about um cancer and, and they just don't want to be a burden on their family members. We heard that a lot. Uh There is a paper that just came out this week um talking about the paradox of the strong black woman, which is something that came up a lot in this cohort where they felt like they had to be the strong black woman and not place their, their burdens and their problems on family members unless it was introduced to them that by telling their family members, they might actually help family members, especially younger daughters and granddaughters, that there would be a concrete benefit to them and that there would be a health benefit to them that was very helpful in helping them get over that unwillingness and say, yes, I will talk about my family history of cancer. I will encourage my family member to get genetic testing because it could actually benefit them. So this is a very complicated tree about the study flow. Uh But really, um the point of it is that what the focus is actually on at every step is what's called pathway we call pathways to care, right? So genetic information independently cannot do anything really, it's just data in a computer. So first you need genetic information, then you need interpretation of that genetic information and then you have something called knowledge, but knowledge is dependent on action ability. Right? So you don't get to power until you can actually do something about something. And this was a problem with a lot of the earlier genetic um testing studies that were done where they got to information plus interpretation equals knowledge. So they were testing people telling them they had, you know, for instance, a gene for hypocholesterolemia but not taking it that extra step to action ability. What can they do about it? How are you actually improving their health? And so that's the important thing about this child is taking from increasing information, trying to get more people tested, but also having a very concrete pathway to care. And so, um you'll see that we wanted to make sure at every stage that if we found somebody who was at increased risk, we did test them, there would always be access to genetic counseling and then into an enhanced breast clinic monitoring so that we weren't giving people information but not providing them with a way to use that information and concretely benefit their health. The second example I'm gonna talk about is human gene editing. This has been in the news uh a lot recently uh with the FDA approval of the uh latest trial for gene editing in sickle cell disease. Uh We have uh a current study which is, is running now. It started recruiting at the beginning of the year. Uh looking at the possibility of, of gene editing prenatally. But this is founded on some studies that we've done previously um in Trisomy 21 which I think everybody is, is fairly familiar with. There was a trial a few years ago of a pharmaceutical that had shown some early promise in uh treating or, or reducing certain signs and symptoms of trust me 21 in Children. And it did go to a clinical trial. Um and that there were a number of Children that were enrolled and the trial was actually shut down early due to what the researchers said was a lack of efficacy data that they didn't think that they were finding any improvements. And a lot of parents of Children enrolled in the trial were pretty upset by that, uh because they felt that they did actually see signs of efficacy that they did feel that there were behavioral changes in their Children. And furthermore that they would be more qualified to identify those improvements than whatever proxy measures the study had set up. So, in response to that trial, we made the gifted study, um and this was a study with caretakers of individuals, uh with Down Syndrome and we offered them five interventions. So one was a prenatal surgery, prenatal gene editing, neonatal surgery, pharmaceutical or a vaccine for Alzheimer's. Um If you're not aware, individuals with Down Syndrome are have a 90 plus percent uh risk of uh of getting Alzheimer's generally fairly early on in their, in their fifties. And so we'd offer these five interventions. Would you be willing to accept each of these intervention? So this is just a table of who was in the trial. This was a survey, it was disseminated online. So we had more than 500 people responded. And what you can see uh in this chart is that the blue lines are people who said yes, I would accept this intervention on behalf of my child. So pediatric physical intervention, those are usually cardiac surgeries, uh neonatal cardiac surgeries, very, very common. Everybody said they would do that. You can see strong support for the pediatric uh cognitive intervention, which would be similar to the pharmaceutical we discussed before. But even fetal surgery, which I think uh most people see it's more invasive and problematic, pretty strong support. What we were interested in was the fact that when we offered that prenatal gene therapy, um not specifically gene editing, but some form of prenatal gene therapy, we got a lot more influence. And uh we thought that was interesting. So some of the content that we talked about is that parents really felt that changing their kids on a genetic level rather than a physical level was especially problematic. It was an extra layer of problematic um because it seemed to suggest that their Children had a pathology in Down Syndrome that they didn't really see as a pathology. So they, it was easy to see a cardiac malformation as a pathology. Uh It was easy to see certain, uh, facial features, cleft lip, all of those, but they had struggled to find genetic changes. Um, that made their child quote unquote who they were, uh, that they didn't really feel like they would be comfortable changing that. So, we did another study, uh, with parents of individuals, uh, twice me, 13 and 18. Uh, and, you know, these parents said, uh it would be ok if that was available, I wouldn't object to it. Uh But I wouldn't, I wouldn't have done it. I wouldn't have chosen it. And in fact, the mother of a living child who tries me 18 again says she seems to be happy. I'm not gonna change her and change her genetics just because um I feel like it or just because I can, we did another study with congenital and progressive sight loss. And, you know, this is an individual who has uh not had sight, he's uh not had sight for their entire life. And they're saying, you know, I actually wouldn't make blindness. Um a target of gene editing. I'd be much more excited about breast cancer. Um And so I think that it was interesting to us because, and in fact, um leber congenital amuro isis is, in fact one of the interventions that is currently undergoing gene editing trials. Uh But this individual really didn't think that, you know, not having sight was a legitimate target or at least the the most important target of gene editing technology, even though it's possible that they themselves might benefit might uh receive uh a therapy that would make them able to see. So those were the preliminary studies that led to the passage study. So this is an ro one from nhtris, as I said, currently began recruitment this week. Um And basically, we were interested uh in much the same way uh that the gifted study is interested in how communities would react to the prospect of prenatal gene therapies across the family system, genetic illness framework. So, uh you can see on the left side, these characteristics, lethal petr and early onset. Um and then over to the right side, not lethal, only a risk factor and early onset, I'm gonna say for our geneticists here, we understand that both autism and deafness are very complex genetically. Uh We are gene editor. Um We have a co I who is an actual scientist who does gene editing. Um But he agreed to let us leave that because there is a lot of discussion in the autism community about the possibility of gene editing in much the same way that there have been discussions about previous neurological research really problematic, the idea of whether autism should be a target of those sort of normalizing influences. And in fact, uh before we even began formally recruiting for this study, the first people to reach out to us were self advocates in the autism community, volunteering to participate in the study because they really felt that they had strong uh things to say. So this uh spectrum, basically, what we're trying to understand is where on this spectrum do various communities place themselves in terms of the appropriateness of prenatal gene editing based on the fact that uh char May 21 those families struggled uh with whether that was acceptable or not. And so we're interested in seeing what everybody else thinks as well. Um So sickle cell obviously is now in gene editing trials. S MA is in gene editing trials. Um There is ongoing research on the recipes which is why they were chosen. And in fact, our colleague who uh is doing gene editing research, their target is a gene editing technique that targets the liver. And they've just received a very large grant to do preclinical studies of PKU with the goal of entering clinical trials in humans in the next five years. So we added PKU. Uh and then I was in a conversation yesterday about gene editing for um osteogenesis imperfecta prenatal A. We may be adding that as well. So the reason we chose prenatal gene editing uh is because it's a technology that's on its way. There's definitely a fair amount of, as we say, animal research bench research that's starting to show us that this may be something that's gonna work prenatally in humans, but it's not there yet. So like PKU is probably and PKU is starting in, in uh Children, nobody's really suggesting prenatal yet. But there's a lot of uh movement around, you know, if we can do it pediatric, would it then not reduce morbidity to do it prenatally? So this gives us the opportunity to see this translational justice question from more or less the beginning um to say what if we trace prenatal gene therapies all the way from the beginning of their, their translation and stayed with them um all the way through. And that's the goal is that, you know, we're now writing additional translational justice questions into these additional grants. So the next grant is about regulatory approval, clinical trials. What are the translational justice questions there? Then we'll do the clinical trials and hopefully we'll have translational justice elements there. Um And so some of the questions that we've started asking, you know, all the way back to the beginning about when you're choosing your hypothesis, what about legitimacy? Right. So there's been a controversy recently in uh Achondroplasia where there was a company that develops a pharmaceutical uh that basically if, if Children take it fairly early on it, uh undoes the sort of some of the effects of achondroplasia in making people short. So it basically allows them to grow taller. But there was a lot of actually pushback from the Achondroplasia community because they said, look, there are lots of things that we would like you to, to study in achondroplasia but being tall wasn't one of them. That's not our problem. Uh You know, most of the disability that attains stro chondroclast is social, right? It's because we have a society that is built for people of a certain stature and that excludes uh little people and we can address that socially. We don't need a drug to address that. So conversations about where the legitimacy of the target is. And again, that's why autism and deafness are on this uh scale because there's been a lot of pushback from those communities about pathologize uh the lack of hearing or pathologize different ways of, of thinking and reasoning in the world. And, you know, people saying those are not legitimate targets of, of gene therapy. And we, we don't want to see that. Obviously, anytime we talk about these sorts of studies, uh commercialization comes up, we've had a lot of ups and downs in the commercialization of genetic technologies going back to BRCA one and two myriad uh the sort of arms race, the cystic fibrosis. Um And so we really want to see if, can we conceptualize a different pathway? Uh You know, the, the drug for S ma famously costs in excess of, of 2 $3 million per child. Uh And while that may make sense, if you look at it from a life course model, it's not sustainable. And so are there different translational pathways we can envision that can make these technologies uh more accessible. I I hesitate to just say cost because if you say more expensive then really, that's just a, a call for insurance companies or, or some other payer to step forward and pay for them. But you know, if you look at the current gene editing trial for sickle cell, it requires a bone, basically the equivalent of bone marrow transplant. So you've got, you know, weeks of hospital stays, breaking down the immune system. It's a very, very intensive uh trial to participate in. And there's many, many people with sickle cell who are not going to be able to a enroll in the child, take that much time off work, take their child and stay with them for seven weeks in a hospital. And so we have to look beyond considerations just of cost to uh what is access look like. So again, there was a story recently of um a family where they had two Children affected by a very rare genetic disease. One is too far developed for therapy, but the younger child is eligible for therapy. There is a genetic therapy company is willing to give them the genetic therapy for free, but Medicaid won't pay for the hospital stay so they can afford it technically because it's free, but they also don't have access. And so I think when we talk about um these kinds of models, we have to look beyond just cost. There's also questions about scientific approach. So if you look again at the example of cystic fibrosis where there were more and more and more mutations identified as being causative of cystic fibrosis. And those were integrated into testing. And then we were basically able to capture a lot of young people with uh cystic fibrosis. The uh treatment has improved astronomically. So we now see people living into uh later into life except for what's called the last 10%. And these are mutations that we can't find uh in individuals that we know are affected. And to go back to our earlier question about efficacy, the mutations, the individuals in that 10% are very largely not European, right? So it surprises not very many people who are in this space that those last 10% those people who are being left behind by all of the the translation that we've already done are from populations that have historically been marginalized. And so what does it look like to begin this process by saying we want to find the rare variants, we want to find the variants that are more likely to be found in populations that have been marginalized historically and then regulatory uncertainty. So again, the reason to go back to that question of safety and researching pregnant people, the FDA has made very clear that they will not allow for the inclusion of reproductive age women uh in gene editing trials uh without the standards of extreme double precautions on contraception. Uh and that, you know, the same, same question all over again, right. And how are we ever going to understand prenatal gene therapy if we are excluding gene therapy, pregnant and lac individuals from gene therapy trials? There's also a lot of uncertainty given the legal landscape surrounding the uh Supreme Court decision in Dobbs versus Texas. Uh that again, enrolling pregnant people in any kind of research is going to become increasingly hard uh due to things called uh like heartbeat loss. And so, is this translational pathway really kind of blocked from the beginning to address questions in pregnancy? Um We don't know that's something that's uh being developed as we speak. Uh But it's certainly a question of, of how we're gonna end up translating these technologies. So I just wanna take a moment to thank uh the many, many, many excellent colleagues uh that we work with on all of the research presented here today. And I'm happy to take questions. Uh My question is, what can we do about it? What are your strategies to overcome this issue of less communication among family members for cancer, family history and for gaining trust among black people for genetic testing? Uh Well, we have a strategy, it's uh in a protocol that is currently at the NC I. Um And that strategy is to uh really do culturally tailored communication. Um So there is actually um uh invite, has a little app that they bought um from clear communication. That is an interactive sort of a I informed family history mapping app. Uh and that you can get on your phone and it allows people to get and documented family history in this app in the privacy of their own home at, you know, at Ledger where they can talk to their mom or their aunt, to their grandmother and be like, oh, did anybody in our family have cancer? So our strategy was to pair uh a sort of culturally appropriate um communication campaign that features black women talking to other black women that features breast cancer survivors, uh who are black women talking about the importance of telling your fam telling your family about your experience. And then uh everybody in the gynecology practice would also get a link um to this little interactive app where they could uh before they come in for their annual exam, they would be able to fill out their family history. And the app actually compares that family history to the NCCN guidelines for um sufficient family history to be screened high risk for hereditary cancer. And then when they cut and that app then sends a message back to the clinic that says this individual has screened as high risk when they come in for their gynecology exam. You need to ask, also ask them if they would like genetic testing. And the provider can actually, the gynecological provider can actually order genetic testing straight from the clinic. Uh And then if the individual tests high risk, they are reflexed to genetic counseling um at a high risk uh breast clinic. So that was the plan. Um It's in partnership to with uh the University of Florida in Jacksonville, uh which is a very high volume gynecology practice and he's a very, very diverse uh population and we just need somebody to fund us to see if it works. Thank you for your question.
