“We want to empower patients and researchers in the microbiome field”,
Heloise is passionately describing the applications of DNA Genotek’s FDA-authorised sample collection device “OMNIgene•GUT Dx” to me over zoom.
In 2022, the device, which stabilises faecal microbiome samples, without the need for refrigeration, has achieved the first and only FDA authorization validated for faecal self-collection and stabilization of bacterial DNA for gut microbiome profiling.
It hasn’t been an easy journey to achieve this De Novo pathway authorisation, it has taken seven years, filled with intensive research, customer feedback, and regulatory considerations.
I spoke with DNA Genotek’s Heloise Breton, PhD (Senior Product Manager) and Austin Udocor (Director, Regulatory Affairs) to delve into this journey, and understand how the OMNIgene•GUT Dx will impact microbiome research.
What does it mean for a biological sample collection device to receive FDA authorization?
A: FDA authorization for our device means a highly respected regulatory body agrees that OMNIgene•GUT Dx functions for its intended use as an in vitro diagnostic sample collection device. It is very gratifying, especially within the microbiome space, to lay the roadmap for this sort of regulatory decision. The authorization came from robust validation of the following: sample stability (30 days at room temperature), Sample neutrality (unbiased representation of the in vivo state), Reproducibility (lot-to-lot and aliquot-to-aliquot) as well as Compatibility with all sample types (adult and pediatric cohorts).
What sort of perspective did each of you bring to the development of OMNIgene•GUT Dx?
A: I came into the project with a curiosity and drive to get the device through regulatory authorisation. My role was to identify the optimal pathway for the device and advise the product team on regulatory considerations. I also engaged with the FDA, so I acted as a contact person of sorts between our R&D and product teams, and the Agency.
H: As a senior product manager for microbiome products, my role was to look at the market, and ask what are the problems the field are facing with sample collection and sequencing services? I worked with the team to ensure the device presented a solution to the challenges of sample collection.
Which features or characteristics would you say make OMNIgene•GUT Dx unique and user-friendly?
A: I think the ease of self-collection is a key feature of the device. Health care is heading towards a personalised, democratic model. The design of the product ensures users can collect samples from their own home, without needing to go, or be present at a clinic. This paired with the temperature stabilising capabilities of the device creates an easy, stress-free experience for the patient/user.
H: The form factor of the OMNIgene is revolutionary and overcomes a lot of the challenges other products on the market haven’t considered. For example, the quantity of sample that enters tube is controlled in our device. The stability buffer makes sample collection less inconvenient as patients don’t have to rush to clinics to return their sample in time. It also opens the door for those users who don’t live near leading research centres to be involved in cutting-edge research, as our device allows for postal delivery of samples.
How would you say the OMNIgene•GUT Dx sample collection kit promotes the standardization of microbiome data?
H: OMNIgene standardises sample input from get go. Our device allows for standardised homogenisation of the sample into the buffer, controlled quantity of faeces being collected, and the buffer is very effective in stabilising the sample. The proprietary buffer is well adapted for the sample type, which is one of the reasons why we see such accurate microbiome profiling using our device. Statistical analysis carried out during our application for FDA authorisation demonstrated the device’s reproducibility.
A: One thing about the microbiome field is that it’s new, so there’s lots of different approaches to research practices, including sample collection. We realised that the promise of microbiome research cannot be realised without a fully validated collection method. By taking the leap to develop an FDA authorised collection kit we can equip the field with the tools to generate more reliable data.
Are there any specific clinical or research applications where you could see OMNIgene•GUT Dx being especially helpful?
A: The stabilising functionality of this device grants researchers the freedom to go into different areas. We’ve recently seen authorisations from the FDA with the likes of Rebiotix, and Seres Therapeutics, we believe this product could accelerate the development of medicines in this category by removing sample collection difficulties.
H: I see a variety of potential applications, I’m particularly excited for the metabolomics aspect. We have seen that the gut microbiome impacts how drugs function, particularly in the oncology space. The more we understand how the microbiome metabolises drugs, the closer we get to achieving precision medicine. If we understood microbiome-drug interactions we could optimise treatment plans for patients, for instance giving them pre-treatment with antibiotics to improve cancer drug efficacy.
What excites you about this product in the context of the future of healthcare and research?
H: I’m excited for the move towards precision medicine. One of the biggest hurdles toward precision medicine is the quality of data. Without robust tools in the data collection workflow the accuracy and reliability of microbiome studies will be in question. In past 3-4 years there has been somewhat of a fatigue facing the field, whilst there has been no major failures in hypothesis, it hasn’t lived up to it’s prior promises. I think the robustness of the science contributes to this, and with this device we are working to change this by ensuring workflows are the very best they can be.
A: If I was a PhD, or scientist, or researcher, going into research I’d be grateful for a device like this. Our device empowers patients to collect samples for themselves, with little training or assistance required. This really removes the headache of existing collection methods which require refrigeration, cannot be transferred by traditional post, and are not room temperature stable.
DNA Genotek work with a lot of microbiome researchers, what research projects you work with are you excited to see the results for?
H: There’s so many, one that is near to being published is a paper examining potential connections between morbidity associated with COVID and microbiome signatures. We’ve also seen a lot of potential in cancer diagnostics, anything that leads to earlier detection and prevention of disease excites me.