Historically, researchers have surveyed the composition and/or expression of microorganisms within the human gut microbiome by collecting fecal samples, isolating microbial nucleic acids, and using those nucleic acids to analyze the microbial species present within the sample. Subsequently, biological fecal samples can provide a wealth of information about the composition, abundance, and activity of human gut bacteria, and these insights have been demonstrated to coincide with specific diseases and health outcomes (source: British Journal of Nutrition).
Analysis of the human microbiome has recently shown great potential in the early prevention, diagnosis, and/or treatment of several diseases and health problems. For example, a microbiome-based diagnostic assay for lung carcinoma detection received an FDA breakthrough device designation (source: The Microbiome Times), and as of 2022, Rebyota was approved by the FDA as the first fecal microbiota product for preventing the recurrence of Clostridioides difficile infection in adults (source: The Microbiome Times). Though significant progress has been made in the translation of scientific microbiome research into clinical and diagnostic applications for patients, the lack of standardization in the microbiome research field and the difficulties associated with reproducing microbiome results remain ongoing and acknowledged challenges (source: Elsevier).
To accurately survey the human gut microbiome, the standardized collection and preservation of fecal samples is the first – and arguably most critical – step to ensure accurate downstream biological data generation from the human gut microbiome.
Back in 2022, DNA Genotek, a subsidiary of OraSure Technologies, Inc., achieved FDA authorization (via the De Novo pathway) for the OMNIgene™•GUT Dx device as a fecal sample collection and stabilization kit validated for the self-collection and stabilization of bacterial DNA for gut microbiome profiling.
As a mailable kit designed for the self-collection of fecal samples in the comfort of ones’ own home, the OMNIgene™•GUT Dx device can be easily integrated into a clinical research workflow to optimize the collection aspect in terms of ease of use, standardization, and reproducibility of results. This device is specifically intended for clinical use by diagnostic and therapeutic developers and ultimately provides a solution to the upfront sample collection challenge. It enables a level of standardization that is critical for empowering and accelerating progress by the industry in the microbiome field.
Achieving De Novo FDA authorization required the development and validation of a metagenomic sequencing assay to evaluate the device’s analytical and clinical performance. The De Novo designation – achieved through the combined efforts of the Research and Development and Regulatory teams at DNA Genotek – provides a huge benefit for developers as it signifies that the OMNIgene™•GUT Dx device has undergone robust validation testing in areas including sample stability, accurate representation of the microbial community, human factors testing, and reproducibility of microbiome results.
With its FDA authorization, DNA Genotek offers the only fecal collection device on the market with regulatory authorization that is ready for use in microbiome clinical tests including diagnostic and therapeutic applications. Incorporating this collection device into relevant workflows will save valuable time and effort by avoiding the need to separately acquire FDA authorization for the sample collection component of a test/assay. This device expedites the translation of research efforts into real world applications, such as clinical tests or assays for specific diseases and health concerns, by providing users and regulatory authorities with confidence that the samples they are collecting will be of extremely high quality.
To learn more about the OMNIgene™•GUT Dx device and our journey in acquiring FDA authorization, please watch and/or listen to our expert panel discussion here.
About DNA Genotek
DNA Genotek has a long-standing history in developing superior biological sample collection products that optimize ease of collection and provide high-quality nucleic acid samples proven to perform in multiple research and clinical applications. Our products allow our customers to focus on translating their results into worldwide advancements in health and science. DNA Genotek’s success is based on our strong relationship with our customers, our innovative environment, and our passion for quality.