So welcome everyone. I'm Dr. Sana Abasi, scientific writer at DNA Geno tech and I'm thrilled to be hosting this panel discussion on Omni gene gut dx, a product developed by DNA Chino tech, for gut microbiome profiling. This is the first and only FDA authorized fecal collection device currently available on the market. This device allows diagnostic and therapeutic developers to acquire microbial DNA for downstream applications, including meta genomic sequencing. So at this time, I'd like to welcome the three panelists who are joining me here today to discuss on the gene got dx, starting with Dr. heloise Breton. From the product management office, Dr. Tara Crawford parks, from research and development. And finally, Austin Unifor, Director of Regulatory Affairs. Thank you all for joining me today. So easing right into the questions, I'd like to ask each of you first off what sort of role each of you had in bringing this product to the market.
So in the product management office, our main role is to identify solutions for our customers that will solve the problems that they're currently having. And when it came to the Omni gene got DX product, which was really interesting was we were actually leaning on experience from our other side of the company, which is our human genomics part of the company. And in that space, for years, we'd already been working on solutions to bring self testing, FDA regulated self testing, to genetic testing. And in the microbiome space, even though it was still very new, and it still is very, very new, we were already seeing that same demand for self testing at home coming up. And so rather than wait for somebody to develop the microbiome test, we took it upon ourselves to take everything that we have learned from the human genomic space, and try and apply it to the microbiome space and develop a product that would bring a at home self collection solution to that market.
Just pick it up. Louise, that was one of the rules of regulatory is to determine understand the rapid pathways for new products. So what we did, we need an experience from the previous gentleman products that we had in the market for some collection devices. And with that, we directly approach the FDA to understand what the problem would be. Because it's microbiome, when it's new, we realize that we have to start early to be able to understand so the role of regulatory is to really understand that religious pathway, because without a, you're not able to anticipate what you'll have to do. So our interaction with the FDA was really useful at this point. So understand what we needed to do. And then we applied it as feedback as we got them to make sure that the product was in so that was my role in supporting r&d, product management and the marketing team to understand what we're going to be facing as we started on this journey that was going to be turned out to be very interesting for for all of us.
Yeah, and just to build on what Halloween is and Austin shared. For r&d, we worked collaboratively with product management and Regulatory Affairs, to engage with the FDA early like Austin said and understand the regulatory framework that we needed to fit our r&d product development studies into. As they mentioned, we had a lot of experience in designing studies and taking genomic products through the FDA. And with the microbiome. Being a newer field, we needed to really understand how we would conduct those studies, and how we would support the proposed intended use of the collection device.
Thank you all for your responses. To further set the stage for this panel discussion. I wanted to ask each of you personally, what excites you about this product and bringing it to market and this could be in the context of regulatory clinical research or healthcare, starting with Austin.
Thank you, Santa. One of my passions is regulatory. Since modernisation regulatory bodies have one main role, which is to ensure that products, medical devices and IVs are safe and effective. It will also have another role which is supporting the patient. For example, FDA will do this by creating new revenue pathways to allow new products that come to market. He was very excited to be part of an approach where we were able to work with the FDA determined and create a new pathway for microbiome products. But that was something that, you know, I had never done in my career.
For me as someone who's been in the microbiome space for almost a decade now, I'm super excited about the potential of this particular scientific field to advance healthcare. There's just so many connections to so many diseases in so many health states. But one thing that we've been struggling with is kind are being taken seriously, as a very new field of science and research, we have to show that we are just as robust as any of the other scientific fields. And so what's great about this new product is it's bringing this level of rigor and standardization and robustness to some of the data that we're going to generate, which hopefully will give people a lot more confidence in the data that's coming out of microbiome research and lead to really cool precision medicine innovations. Building off of what Hallowee said, my passion is really translational science and how we can enable the industry towards precision health, particularly in the microbiome field, as Halloweens alluded to, it's still very much in its infancy, and we don't have a full understanding yet of the potential that the microbiome can have on precision health. So what really excites me about bringing this product to market is that it provides a solution to the upfront sample collection, to enable that standardizing standardization, which is really critical, empowering and accelerating the diagnostic and therapeutic industry in the microbiome field.
Thank you all for those answers. It's really interesting to see the different perspectives that each of you brings to the table. Moving on, as we all know, in 2022, Omni gene gutt, dx was granted FDA authorization. So my question now to all of the panelists is, in your personal opinion, what does it mean for a biological collection device to be granted FDA authorization, maybe could each of you offer one reason why this designation is meaningful for our kid or for any other sample collection kit.
These are MB agrees with us. Right? When a regulator like FDA reviews your data and approves an authorized device, it's somebody needs something. Additionally, if you consider the stature among regulated revenue bodies, FDA is one of the leading regulators either they've looked at our products, and they agree that it meets intended use close to them. So when and this is something that microbiome if you're being very new, and developing requires a need to proceed to the next to the next phase.
For me, from a scientific perspective, when a product like this receives FDA authorization, it demonstrates that there was a robust level of testing done to prove this scientific validity and the clinical utility of the product, which ultimately speaks to the quality of the product, and allowing for a level of confidence when integrating these types of products into our workflows. In addition with the Omni gene got DX device, because we took the denoble pathways Austin alluded to earlier, that also speaks to the level of innovation that the product is bringing to the market. And for us, when we're trying to market the product, there's only so much we can say with our own data. Getting someone else's stamp of approval on the performance of this devices speaks times to our market and our customers. And we hope it gives them the added confidence that this product will deliver on the claims that we're making.
Thank you all for those responses. My next question now is for Tara, specifically, Tara, what sorts of internal validation tests have we conducted to receive the FDA authorization?
That's a great question. Thanks, Donna. Because we had to follow the de novo regulatory path, as we've already mentioned, that meant that in addition to the testing required for the sample collection device, we also had to develop and validate meta genomic sequencing assay that would serve as the functional endpoint for all of our analytical and clinical performance studies. As part of this verse staff, it took a lot of strategy, internal discussion and engagement with FDA to really understand how we could validate such an assay to fit within existing regulatory framework and provide data that the FDA was used to seeing, but also adapt to this new emerging microbiome field. And that was really exciting because we were able to expand our already strong expertise in the genomic space in the regulatory environment to encompass this new and emerging microbiome field.
Thank you, Tara for that answer. Knowing what we know now about FDA authorization. Austin, can you speak to some of the setbacks that we faced in receiving this designation for this device?
Thanks, Anna, I would say there were challenges. The first one we have to try to do was assess if there was a regular pattern that exists for microbiome products. As we engage with the FDA, we knew found out there was none. And so that's that we then went to work with FDA over several years to propose the intended use and then to get feedback from them how we were going to go ahead and create this new pathway to get this product clear. During that process, we learned a lot about the FDA requirements. But the first thing FDA did was to make sure that they would be allowed to work with us to make through that they were listening to us taking that feedback, and ensuring that there was a theme of working with us with step by step to create that pathway. Along the way, there were many challenges. As I said before, Monday minute, which I can go into detail, obviously, but which we are happy to share with your friends of ours who come to us to work with you talk about how they can take their own products into the market. One thing that I can say for sure, during this process, the FDA remained engaged with us, you know, weeks and weeks, even during the COVID pandemic, they stayed on point to ensure that the product and the pathway was there. At the end of this, what came out of it was FDA had to create a separate product category for microbiome products. This V was the beginning was the was the combination of all of these efforts over several years, to ensure that the product like this did not have that did not have a pathway in the end came up with we ended up with a new category for products that we can take from microbiome. The last thing I wanted to say to set us on in terms of the challenges was, it does have ABS approach, EPI is number one job is to make sure the product is safe, and that it's effective. In working with us, even though they had to create different pathways, it did not neglect doing that particular job. They made sure that our data or data matches the intended purpose. The measured data proves that the product was safe and effective for intended use. I would propose that those challenges coupled with the expression that we gain, I think was enough for us to understand that this product we went to the rigor was enough for us to understand that this product was really assessed from this perspective. And then we've got the front authorization obviously, it was really, really well worth.
Thank you, Austin, that sounds like it was challenging to overcome. Moving on. My next question is for you Halloween, it's well established that standardization is needed in the microbiome research field. How would you say on the gene gap dx, promote standardization of microbiome data.
The success of the microbiome workflow is very dependent on the quality of the technology used at every step. So there are some crucial steps such as extraction. So actually extracting the DNA sequencing, the bioinformatics pipelines that are used to analyze that data, and we know that each of those will introduce a small amount of bias, that's just the technological burden that we deal with. But when you think of that workflow, if what you're putting into it at the very beginning, in terms of your sample type is not of good quality than every single step after that will suffer even more. And the chances are that what you what is going to come out of that microbiome workflow is potentially not going to be as powerful as it could be. So I know sometimes it seems silly to really focus on that first step of sample collection, but it is so important ensuring the success of that whole workflow. So by standardizing that very first step of how the sample is collecting, ensuring it is of the utmost quality, it means that no matter what happens next, at least you've controlled for that first step, and you're ensuring more success down downstream.
Thank you, Luis, for that response. My next question is for you, Tara, what sorts of clinical applications do you see this product being especially helpful for?
That's a great question. When I think about potential clinical applications for the Omni gene get dx device, the oncology field comes to mind first, specifically, for example, colorectal cancer or CRC microbial associations with CRC are well recognized and field. And these signals could be used in broad scale screening programs. The Omni gene gap DX device could enable non invasive sampling from patients within the screening programs to increase access to patient populations that are at higher risk for CRC. We know that in the US African American populations are at a higher incidence of CRC and increased mortality compared to other demographics within the population. And so enabling broader access for at home self collections of the samples could help mitigate some of those disproportionate health outcomes. And so taking a step back, when we think about the validation that we did to evaluate the usability of the Omni gene get device, we were able to demonstrate and test that lay users across the general US population could follow the collection instructions, collect a successful sample and ship it back to a processing Laboratory, which is really important when you think about the impact of that for these broad screening programs, ensuring user compliance, the successful collections will feed into reduced study times and costs for these broader programs.
Thank you, Tara for that answer. To wrap up this panel discussion. I'd like to hear from each of you one last time on where you see the clinical research and regulatory fields going in the future when it comes to studying the gut microbiome. Starting with Oster,
I think I'd like to see more regulatory system organization. I'd like to see the FDA and other regulators work with the microbiome test developers to further their technology. I think this is the only way this is one of the only ways to make sure that this technology has come to market, and innovation that we're leading in this space comes to fruition.
For me, it goes back to, you know, my excitement around translational science, translational medicine and precision health. As I mentioned, there's been, you know, a lot of microbiome research and discovery work in the past decade. And now we're at that point where we can translate that to diagnostics and therapeutics. And as Austin said, it will be an exciting time as drug developers and assay manufacturers start going through a similar process that we've gone through with the Omni gene gap, dx device, and really getting their offerings and their technology to market so that as a population we can benefit from including microbiome, biomarkers, for example, into our healthcare. And to go off of what Austin and Tara just said, I think, you know, regulatory bodies, such as the FDA will are going to receive a lot more clinical data that has microbiome as a component, whether that's drugs that are specifically targeted at the microbiome, or just assessing the impact a therapeutic could have on the microbiome, because that's what the space is showing us that you know, everything you do has an impact on your microbiome and have an impact on your health. And I would just like to see more information come out about how those clinical trials can be run successfully and powerfully so that we don't get setbacks where you know, clinical trials and phase two and don't go on to phase three, so that we see more success in this space, and we see this space accelerate in the next few years.
Awesome, thank you all. To wrap up this panel discussion. I'd like to thank each of the panelists for joining us here today to discuss the Omni gene gut DX device in the context of FDA authorization. Thank you
