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Pushing the Boundaries of Molecular Diagnostics
Episode 391

Oguzhan Atay, Co-founder & CEO at BillionToOne

Pushing the Boundaries of Molecular Diagnostics

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Pushing the Boundaries of Molecular Diagnostics

Episode 391

Recommended Book:

Thinking, Fast and Slow

Best Way to Contact Oguzhan:

oatay@billiontoone.com

Mentioned Link:

Company Website

Pushing the Boundaries of Molecular Diagnostics with Oguzhan Atay, Co-founder & CEO at BillionToOne transcript powered by Sonix—the best audio to text transcription service

Pushing the Boundaries of Molecular Diagnostics with Oguzhan Atay, Co-founder & CEO at BillionToOne was automatically transcribed by Sonix with the latest audio-to-text algorithms. This transcript may contain errors. Sonix is the best way to convert your audio to text in 2019.

Welcome to the Outcomes Rocket podcast, where we inspire collaborative thinking, improved outcomes, and business success with today's most successful and inspiring health care leaders and influencers. And now your host, Saul Marquez.

Saul Marquez:
Welcome back to the podcast. Today, I have the privilege of hosting Dr. Oguzhan Atay. He's the co-founder and CEO of BillionToOne, a venture backed capital molecular diagnostics company. At BillionToOne, Atay helped develop a patent pending molecular counter platform that increases the resolution of cfDNA testing by over a thousand fold. This technology unlocks a wide range of diagnostics from a single gene non-invasive prenatal testing to quantitative liquid biopsy applications for cancer. The company raised over 15 million in series a funding from prominent investors and just launched its first product, a prenatal test called UNITY. The only non-invasive prenatal test that uses a single sample of the mother's blood to determine whether the baby has inherent disorders such as cystic fibrosis and sickle cell disease. Previously, Atay graduated from Princeton University at the top of his department's class in molecular biology and holds a PHD from Stanford University, where his work was published on the cover of cell systems. His experience in the field is providing promising results early on, and it's exciting to finally have a product where mothers and families can find these things out. So in this podcast today, we're gonna dive into all of Oguzhan's ideas and how the company came about and definitely looking forward to the opportunity to hear more. So. Oguzhan, with that, I want to give you a warm welcome. Thanks for joining us.

Oguzhan Atay:
Thanks for having this opportunity to talk with you. And thanks for your kind introduction.

Saul Marquez:
It's a pleasure, Oguzhan. Now, what would you say got you interested into the healthcare space?

Oguzhan Atay:
I truly believe that the molecular diagnostics can be so much more powerful, accurate as well as affordable if it were engineered to be quantitative. And I saw that it wasn't so. Given kind of my interdisciplinary background in physics and biology, I feel how much of an impact that I could make, especially with the developing exponential trends in sequencing and bioengineering. So it was really an exciting time to be in the medical sector and I think we will see rapid changes and improvements with all these trends coming together.

Saul Marquez:
Oguzhan, I think what you highlighted is really interesting, right? The idea of this interdisciplinary approach and the quantitative background in molecular diagnostics. I'd love to just take a couple steps back and spend a little bit of time just sharing your knowledge with the listeners to level set everybody on what your thoughts are on molecular diagnostics, what the promises and why this interdisciplinary approach is critical with that quantitative background?

Oguzhan Atay:
Yeah. So I think the personalized and precision medicine has been really bringing together different fields to transform medical care. And in particular, sequencing has been improving really exponentially. And when there is an exponential trend to possibilities, it pulls up are almost limitless. But even with these improvements, we don't get as much out of this data as we initially imagined, and the quantitative approach the way to approach biology almost from the fundamental physical principles allows one to ask what is possible instead of just lightly doing trial and error experiments that only improve outcomes and tests in incremental changes. I think it allows you to do innovation in an almost paradigm change – step change chunks.

Saul Marquez:
So it's really understanding the building blocks and how the building blocks interact so that we could do more predictive and scientific approaches to it?

Saul Marquez:
Yes, that's part of it. And part of it is just how we design our tests and assays. I think predictive is a very good role. He allows you to, instead of trying causal different experiments, really engineered the diagnostics in a way that you have a very good idea of whether something is going to work or not. Before you spend all the resources to building it.

Saul Marquez:
That's fascinating. Yeah. It's an interesting approach. And I feel like it's it's, you know, diving deep into a level of of science that really is is critical. Right. With that, let's question what models we have today. Let's a question if they're good enough. And that's exactly what you and your company are doing, right? Oh, Oguzhan, you're questioning the good enough factor. It could be better.

Oguzhan Atay:
Yes. Yes, definitely. And I think the difference is that if you approach the problem from a more fundamental physics or engineering way, the problem statement even changes it does it no longer. But essentially, if you tried this, whether it is going to make it slightly better, it starts from the concept of what is physically possible, what is, what can be the limit of what we can measure. And it is a very different way of, I think, approaching the problems than a lot of the traditional biology approaches. It is what a lot of engineering approaches used. And now that we are learning and knowing much more about biology, I think it is time for us to be able to use those approaches to make great innovations in medical care.

Saul Marquez:
That is fascinating so as you guys have done different experiments, you've finally launched your first product. So tell us a little bit about that product and how it made a difference thus far. And it's called UNITY, right?

Oguzhan Atay:
Yes. Yes. It's called UNITY. So what we did was we built a molecular counter, something that allows you to count individual molecules and that improved the cell free DNA diagnostics resolution by more than a thousand fold and is very important because all of our tissues shed DNA into the blood stream. And by analyzing this DNA, people have realized that we can do prenatal and oncology tests that were previously only possible via invasive techniques. I mean, this has been the fastest growing diagnostic sector in history to really transformed medical care. But even with these approaches, a lot of the current technologies were limited to more of the qualitative measurements, whether a particular mutation is present or absent. By building this molecular counter, the really improved resolution from chromosomal changes things that are millions of base pairs to a single base spare change. And if you think of your genome as a huge library, most of the disorders, most of the genetic disorders are caused by these single letter changes, not these huge chunks of the library disappearing. So in that sense, unity that this first product that we build allows us to do look at these disorders like cystic fibrosis and muscular atrophy and sickle cell disease from maternal blood and find whether the baby has inherited these disorders. This is an established field in terms of there are existing medical guidelines that say that every pregnancy should be screened for these disorders. But currently the only way to truly find them in the baby are to embrace the methods like amniocentesis that can cause miscarriages because you can not do amniocentesis on every pregnancy. What happens currently is that the parents get screened, but paternal DNA testing is often not possible due to a list of reasons like 40% of US pregnancies are single mothers. There is about 5 to 10% non paternity. Forty eight percent of U.S. pregnancies are Medicaid and the paternal DNA test is not reimbursed. So there are a lot of logistical and inherent reasons in the system where these disorders should be screened for but do not get screened for. And UNITY allows us to take a single sample from mother's blood and find out not only whether the mother is a carrier for the disorder, but also whether the baby has inherited that disorder.

Saul Marquez:
So it goes back to the concept that you that you mentioned Oguzhan about tissue sheds, DNA into the blood. Right. You guys are able to pick up on this with the molecular counter.

Oguzhan Atay:
Yes, definitely. So it really allows us to quantify the level of the mutations that you have, for instance, for cystic fibrosis versus the non mutated DNA molecules. And by being able to truly quantify that, we can see the additional contribution that is coming from the baby. So we can say that the baby has two copies of this DNA molecule that has mutated because we say there are more molecules with the mutation than kind of wild type the original molecules in maternal blood.

Saul Marquez:
That is fascinating. I think back to, you know, I my son is two and a half years old. I think when my wife was pregnant and the tests that we, that she took. Yeah. I mean, and then, you know, what I was most intrigued by is just the fact that you could tell if it's a boy or girl like your blood,.

Oguzhan Atay:
That is actually one of the easiest thing that we can do.

Saul Marquez:
Is that right?

Oguzhan Atay:
Yes, because it is a whole chromosome and there is nothing of that. One of the easiest thing that you can do.

Saul Marquez:
You're like, that's a piece of cake. You shouldn't be impressed by that.

Oguzhan Atay:
Well, technically true quantification. You can tell whether the baby has blue eyes or, is going to be curly or not.

Saul Marquez:
Seriously?

Oguzhan Atay:
Technically…

Saul Marquez:
It's amazing.

Oguzhan Atay:
Kind of – true quantification. You can tell anything and everything about the baby genetics.

Saul Marquez:
Unbelievable. Wow. Super interesting. And especially with the diseases that you want to know most about for your baby. Something to think about, folks. Now, is this commercially available in the U.S.?

Oguzhan Atay:
Yes. We just launched the test actually this month.

Saul Marquez:
Congrats, man.

Oguzhan Atay:
To clear the regulatory aspects of it. So it is available now.

Saul Marquez:
You clear the regulatory minefields alive?

Oguzhan Atay:
Yes. Fine.

Saul Marquez:
Congratulations. So, folks, pretty intriguing technology will definitely have a link to it and to the company that Oguzhan is leading here out of Menlo Park, California. Definitely. Check it out. So as you and your team prepare here for the for the next phase of the company and the things that you've been up to, I love to hear sort of a maybe a setback that you guys had and what you learn from it that's allowed you guys to have the success you've had?

Oguzhan Atay:
So a personal setback and I think this happens with a lot of the CEOs that have come from academia was really learning how to be a CEO. And the first fundraising that I have done was very difficult, probably the most difficult that I had. And there was this one one event that is, I think, a little funny, but also important for other people to realize is that you were doing this seed run and there was this small fund that wanted to write a very small check for us and contribute to our.. and because they like what you are doing.

Saul Marquez:
Yes.

Oguzhan Atay:
And if I didn't have time to meet them and it was a very small check, they will still write. Right. So at the last moment, my calendar had been opening. So I told them that I could meet them. And then in the meeting, they started asking questions about the good entry and details. And I started to explain to them the minefield that mark access, the reimbursement process, all of its details in a complicated way. And at the end of the meeting, they kindly told us that they were not going to write a check after all, I unconvinced an investor who was convinced to begin.

Saul Marquez:
Oh my goodness.

Oguzhan Atay:
So that might have been that might have been the end of one of the lowest points in my book.

Saul Marquez:
Yeah. Oh, my gosh. And so what was the lesson learned there?

Oguzhan Atay:
I learned that your ability to be a visionary and to explain the to the accurate, but all of a missing way is at least as important as the science and knowledge. The way that you explain something is as important as the facts of your explanation. So I started putting a lot more emphasis in how I explain the concepts and how we are doing now.

Saul Marquez:
It's a great learning for sure. And yeah. You know, you got to be good on both sides of it. It's not just the science. It's the presentation of that science in a way that makes sense for. For investors and people and no, it's a great lesson. And so how about one of your proudest moments to date what would you say that is?

Oguzhan Atay:
I think just UNITY itself, how we were able to build a state of the art, clinical lab, develop and validate unity it extremely high sensitivity and specificity about 99%. And we launched that within the time frame and resources that we have. It often takes years of trial and error approaches with huge teams to develop and launch a single unique diagnostic test. You're able to do it with a very small but stellar team and maybe less than half the time, but also much more rigorous standards than required by regulations. So that I think being able to recruit the team, the team that was able to do that was I think is my proudest moment.

Saul Marquez:
That's awesome. Hey, kudos to your team for the hard work that they've done. So how about the regular, not the regulatory, but the reimbursement pathway? Is it is it pretty clear?

Oguzhan Atay:
Yes. So the technology from that, the build is applicable to many diagnostic. It really transforms molecular diagnostics and makes it a quantitative. One of the main reasons they chose this particular area in this particular test is also because of the reimbursement. We don't even build for the test that we developed actually. You test the mother, right. And then if it is positive, we find out whether the baby has inherited that disorder. The testing of the mother is an established market and that has existing CPD codes and it is commanded by guidelines. So we only really rebuild for those CPD codes for mother's carrier test.

Saul Marquez:
Yes.

Oguzhan Atay:
this is already a 2 billion dollar market per year in the U.S. So we don't even really charge for the kind of old extra value add that we have UNITY.

Saul Marquez:
So you're basically and that makes a lot of sense here. You're adding more value than anybody else in the market and therefore introducing yourself as a value added option to take share.

Oguzhan Atay:
Yes. Yeah.

Saul Marquez:
Awesome. I love it. And it's great, right? Because that's the beauty of innovation and the benefit to consumers and and practicing physicians is when things get better and there's existing codes to back them, then you doesn't increment your cost but it enables you to increment the value added to patients, which is which is inevitably a great thing.

Oguzhan Atay:
Yeah. Yeah. I mean, the feedback that we received from OBGyn, genetic counselors, medical diet has been phenomenal. Like almost everyone recognizes how broken the current carrier testing workflow is. You test all these mothers, you get all these positives and it doesn't even really lead to any actionable outcomes because you don't figure out what the baby has at the end of the day. And they realize how community would fix it. And they really like the fact that it's not a five thousand dollar out of pocket test. It is how would benefit from the day one.

Saul Marquez:
That's awesome. And frankly, I'd tell you what. That definitely is a proud moment. We always talk about. All right. How do we add value? How do we add innovation? Right. When you when you think of the traditional equation for am I doing value based care? You divide it by how much value you're offering an additional cost that's coming in and you're not adding additional cost. Yes, but you're giving so much more value.

Oguzhan Atay:
I mean, the are in fact, decreasing a lot of the health care costs. I mean, if the mother is a positive, then the father needs to get screened in the current workflow. They don't require that. So it cuts down the test cost, but it also, in terms of actionable outcomes, improves the health care outcomes in a very significant way as well.

Saul Marquez:
Man, that is so cool. I mean, I think it's it's a really neat approach that you guys took. And I mean, how did you guys land on that?

Oguzhan Atay:
So I think we landed on that by just realizing that most diagnostic companies fail not because they have a bad product, but because it takes years of trying to convince the system that their product should be paid for. And that realization that I mean, Gates Foundation sponsored the research. So doing this, why diagnostic companies fail? Number one reason well, that it takes years for reimbursement to kick in and they don't get paid. So we started thinking about, okay, what would be a way to build a product from day one? What would be a way to add value to the system and still get paid by building a diagnostic products that falls in a very important unmet medical need, but also enables us to use the existing system to get paid.

Saul Marquez:
Man that's genius.

Oguzhan Atay:
Thank you.

Saul Marquez:
I love it. And it's the power of questions, folks. If you think about the business models that you're that you're shaping the example that Oguzhan just kind of gave us as know you don't have to invent something and try to convince the system to form new reimbursement. Think about that reimbursement model that exist. What player is there? How can you add more value than that player and take market share while improving outcomes? That's the key. Love it, love it. Love it. And so what would you say is the exciting project or focus that you guys are most tuned into right now?

Oguzhan Atay:
So…

Saul Marquez:
UNITY, right?

Oguzhan Atay:
Yeah. It's UNITY. We want to get unity to the hands of essentially every physician in the country and really make it the gold standard for carrier testing. I mean, it is how it should be done. So focusing on that and making it available is our our primary goal. But we also realize that the molecular counter that we build tools, many other molecular diagnostic solutions, and we really want to build solutions that are not only affordable and not only reimbursable, but also we want to build them in a way that the cost structure of these solutions enables them to be distributed globally. So that is another thing that we are working on, both with UNITY and the oncology diagnostics that we are working on, that making sure that the price the cost of the test is so low that they can be sold through distribution partners globally.

Saul Marquez:
Beautiful. Well, the mission's there and also the economic proposal and the structure is there. So certainly wishing you guys the greatest success in your next steps. Getting close to the end here. Oguzhan, we've got a lightning round, followed by a book you recommend to the listeners. You ready?

Oguzhan Atay:
OK.

Saul Marquez:
Let's do it. What's the best way to improve health care outcomes?

Oguzhan Atay:
It is, I think, interdisciplinary approaches that enable true paradigm change in innovation.

Saul Marquez:
What's the biggest mistake or pitfall to avoid?

Oguzhan Atay:
There is a great TED talk on I think it's called "Start with why" that I really like. It explains how the leaders should have a wise statesman for their companies and products to exist. I think it is critical to start with that. Why does your company exist if you don't have that? I think it's the biggest, biggest pitfall. The biggest mistake.

Saul Marquez:
Amen. Love that one. Simon Sinek, you guys haven't seen it, want to check out. How do you stay relevant as an organization despite constant change?

Oguzhan Atay:
I think it is recruiting the right people. Recruiting superstars and empowering them are trying to create the Bell Labs type environment where the innovation is the only constant.

Saul Marquez:
What's an area of focus that drives everything at your company?

Oguzhan Atay:
True quantification. So if if we truly believe that if we have true quantification that enables unprecedented improvements in molecular diagnostics.

Saul Marquez:
Man doesn't get any clearer than that. Appreciate that. And so the next two that I have here are more on a personal note for the listeners to get to know you, Oguzhan. What's your number one health habit?

Oguzhan Atay:
I think it is just taking time to relax and also always separating, locating time to turn off. Is this you? Sometimes there is always more that you can do and it is very important to be able to turn it off and be able to sleep every day really well.

Saul Marquez:
Love that. Love that. And what would you say is your number one success habit is success habit?

Oguzhan Atay:
I religiously use calendar one for personal things. There is a time for allocated for even thinking in my calendar. I think that allows you to focus on long term strategic arc of the company and not kind of pigeonhole yourself to solving only the short term problems then the fires that you have to put out.

Saul Marquez:
That's a great, great habit, my friend. I, too, schedule think time. It is critical and I love it. Appreciate you sharing those tidbits there. What book would you recommend to the listeners?

Oguzhan Atay:
That's a difficult question. There are so many books that I could recommend. I read a lot, but I highly recommend Thinking Fast and Slow by Daniel Kahneman. Thing is, is we operate and make decisions. We make too many implicitly biased decisions without even being aware of it. It's a great book in kind of describing all the biases that we have

Saul Marquez:
Love it. Great recommendation and folks, for the show notes and entire transcript of our discussion with us on today, you could go to outcomesrocket.health and in the search bar type in the name of his company. It's called the BillionToOne. And you'll find all of the things that you might be curious about if there were links about – right there. So, Oguzhan, this has been a lot of fun and very educational love. If you could just leave us with the closing thought and then the best place for the listeners to get in touch with you to continue the conversation.

Oguzhan Atay:
I think it was impossible to predict the current period that we are living in when transistors were first developed. In the same way, I think we are in an exciting period that to see many paradigm changes and improvements in medical care. I am very optimistic about the future and that is my closing thought. You can contact me by emailing me – oatay@billiontoone.com.

Saul Marquez:
Outstanding. So Oguzhan, we'll leave that email there in the show notes as well for the folks that want to continue the conversation. And folks also feel free to check out the website at billiontoone.com where you could check out the UNITY test, their publications, and all the other outstanding things that they're up to, including open positions because they're hiring. So with that, Oguzhan, I want to give you a big thanks for sharing your story and I encourage you to continue doing what you're doing.

Oguzhan Atay:
Thank you. Thanks for giving me this opportunity to talk with you.

Thanks for listening to the Outcomes Rocket podcast. Be sure to visit us on the web at www.outcomesrocket.com for the show notes, resources, inspiration and so much more.

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