Writing a top 10 list for each year has been a tradition at DNA Genotek since 2009. This is my first time penning the article and I’m lucky to have so many topics to choose from in 2016. When we published the first version in 2009, we were a company focused exclusively on the human genomics market. Now we have expanded our human genomics offerings and we’ve launched new products and services for the microbiome and infectious disease markets. While my name appears as the author of this article, I received input from the entire DNA Genotek team for what should appear on this year’s list. After much deliberation, here’s what made our top 10 list for 2016.
1. Large global health initiatives. The year 2016 has seen a marked increase in the coverage of both human genomics and microbiome in the mainstream news media, primarily due to large projects such as the Personalized Medicine Initiative (PMI), the Cancer Moonshot and the National Microbiome Initiative. These broad initiatives have very lofty goals for enrolment and ultimate impact to advances in healthcare. They aim to engage a wide variety of individuals with or without specific disease conditions. Mainstream media coverage resulted in a greater understanding and interest in both genomics and microbiome to the public.
2. Individual empowerment and access to health information. We have the privilege of working with customers around the world who are dedicated to improving healthcare. For example, Helix’s genetic information discovery service will use our Oragene•Dx device to provide reliable self-collection of DNA samples and our GenoFIND services will provide kit fulfillment and logistics services. Helix aims to offer a broad range of genetic based applications that will empower individuals with increased access to information about their own health. In addition, the Broad Institute of MIT and Harvard University is using Oragene for the Metastatic Breast Cancer (MBC) Research Project, which is using a unique approach to patient recruitment and engagement. And, a research group in British Columbia, Canada looked to local community pharmacists to bring precision medicine closer to those who can benefit most at point-of-care within the pharmacy. These are just a few examples of the great work being done by our customers and we’re so excited to be a part of these projects.
3. Call for standardization of microbiome sample collection and stabilization protocols. Standardization of microbiome protocols was a topic that gained momentum in 2016. It was discussed at a National Institute for Standards and Technology workshop and is required to make large scale microbiome research efforts like the White House's National Microbiome Initiative In 2016, a new publication in Nature’s Scientific Reports entitled “A robust ambient temperature collection and stabilization strategy: Enabling worldwide functional studies of the human microbiome”, tackled both of these topics as part of the Human Longevity Inc. program to bring standardization to their microbiome sequencing process. The Microbiome Team at DNA Genotek is especially proud to be a leader in this community, contributing innovative products, data and best practices to these initiatives. The benefits of standardization enable academics to aggregate data across studies with confidence, and allow funding agencies to de-risk their investments in this rapidly evolving field.
4. Spreading the word (not Tuberculosis) – This year, four journal articles about OMNIgene•SPUTUM were published by our collaborators. These research studies demonstrated the reagent’s performance in remote settings, and its compatibility with smear microscopy, solid culture and the GeneXpert®. It is thanks to our global collaborators and testers that we are able to openly share this data with the TB community. We also launched our new blog “The Infectious Disease Spotlight” where we bring news and updates on our products and the global health space. Spread the word – not the bug! You can subscribe to our blog to stay up to date on these topics.
5. Sequencing in the clinic– This one was on our 2015 list and it merits repeating. In 2016, targeted and whole genome sequencing in the clinic continued to grow its influence as an important diagnostic tool. Detailed genetic analysis can now be done in small centers as well as in large genomics facilities. The scalability, speed and accessibility of sequencing is making a significant impact in clinical research and in patient diagnostics and treatment.
6. ORAcollect•Dx FDA 510(k) clearance. In June of 2016, our ORAcollect•Dx collection device was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA). ORAcollect•Dx joins our Oragene•Dx family of products as the only saliva based DNA collection and stabilization devices to receive 510(k) clearance. ORAcollect•Dx is an attractive alternative to buccal swabs and offers several advantages including a liquid sample for improved lab efficiency, and the elimination of manual steps like cutting tips which reduces the chance of errors and cross-contamination. In addition, the product has been demonstrated to provide higher DNA yields than buccal swabs, reduces bacterial contamination and is stable for months at ambient temperatures. Our FDA clearances provide access to proven, saliva-based collection devices for diagnostic companies and healthcare facilities of all sizes who want to deliver an improved patient experience as well as facilitate growth of their testing services through easier access to patients.
7. The launch of our Open Microbiome Network Initiative (OMNI) Project. In 2016 we launched a new, open microbiome research study called the OMNI Project. This is not your average microbiome study as we used alternative participant recruitment methods by enrolling attendees at major GI conferences such as Digestive Disease Week. Samples are collected using the OMNgene.GUT kit and are processed and analysed through our GenoFIND services. The OMNI Project includes a secure online study portal allowing two-way communication between participants and study coordinators. Participants have access to instructions, their personal microbiome report, and updates on the research progress. The project uses validated protocols for collection and analysis, ensuring well controlled and standardized results. Our OMNI project is expected to encourage international collaboration and promote the advancement of microbiome research.
8. Preview of the Oragene 600 series at ASHG 2016. We’ve always solicited our customers’ feedback to help guide our product evolution and the Oragene 600 format series of products is the latest result of customer input. Previewed for the first time at ASHG in Vancouver, the 600 series of DNA saliva collection kits combine the ease-of-use and reliability you have come to expect with the ability to tailor the device to your preferred configuration. The 600 series provides enhanced flexibility for sample handling, traceability and storage with improved automation features and will be available in the Oragene•DISCOVER, Oragene•DNA and Oragene•Dx product families.
9. Building strong partnerships and communities in the fight against TB – In 2016 we started working on several key collaborations in the tuberculosis space. The Foundation for Innovative New Diagnostics (FIND, Geneva, CH) is evaluating OMNIgeneSPUTUM as a transport medium to preserve sputum samples collected from patients located in remote settings in Ethiopia and Peru. This study is taking place thanks to support from the Stop TB Partnership’s newest social impact fund, Venture Lab (vLAB) and the Accelerator for Impact (a4i) initiative. 2016 was an exciting year to work in a community that is committing to bring new and innovative solutions to fight TB to the countries who need them most.
10. Working with the best team in the industry. Finally, I'm particularly proud of our employees and their attention to our customers' needs. I watch them pull off small miracles on a daily basis with impeccable attention to detail and a genuine compassion which results in an outstanding focus on quality and service. They do this because they believe in the work our customers are doing around the world. Thank you for allowing us to serve you.
Oragene•Dx and ORAcollect•Dx have been cleared for in vitro diagnostic use in the U.S.A. FDA cleared for in vitro diagnostic use with the eSensor® Warfarin Sensitivity Saliva Test. Oragene•DISCOVER is for Research Use Only, not for use in diagnostic procedures. Oragene•DNA is for In Vitro Diagnostic Use. Oragene•DNA is not available for sale in the United States. GenoFIND is for Research Use Only in the United States. OMNIgene•SPUTUM is registered as an FDA class one general purpose reagent for laboratory use in the US. OMNgeneGUT (OMR-200) is for Research Use Only, not for use in diagnostic procedures. OMNgeneGUT (OM-200) is not available for sale in the United States.
Some DNA Genotek products may not be available in all geographic regions.