To obtain insight from the genes and single nucleotide polymorphisms that make every individual unique, consumers have until now relied on the remote provision of genetic testing services. Recognising the need for DNA profiling to be faster, and test results more accessible, DnaNudge wanted to create a point-of-use device suitable for in-store genetic phenotyping. This would be coupled with the nutritional information of manufactured food and drink products and used to promote healthier purchasing choices. To achieve this, DnaNudge approached TTP to develop a device for DNA extraction and analysis.
We initially approached TTP with our concept regarding personalised DNA testing. We were impressed by TTP’s desktop biology offering and saw an opportunity to accelerate the development of our technology and chemistry. TTP understands the fundamental steps required to convert lab-based biological processes to functional instruments. Working in partnership, we have been able to develop our product with TTP from concept to manufacture which, together with our database, will enable consumers to make more informed and healthy food choices, leading to improved health outcomes.
A major challenge of our project brief was to transfer a complex multi-step laboratory workflow, typically carried out by a qualified technician, into an automated process operable by a shop assistant. In addition, the constraints of a consumer environment demanded that our solution be embodied into a compact, user-friendly instrument and low cost single-use sample processing cartridge, allowing for walk-away operation and flexible integration with accessory products.
From the outset, we utilised our multi-disciplinary expertise to anticipate and mitigate risks that had the potential to extend project timelines. With a well volume of <2µl, it was vital to assure highly reproducible, laboratory-accurate PCR results at low volume. We achieved this by creating novel IP around fluidic and thermal control and designing a custom module for low volume thermal cycling. We also developed a set of primers and buffer formulations suitable for low volume PCR, complementing these with various measures to prevent inhibition of DNA amplification and avoid signal crosstalk.
Our product-oriented design process was fundamental to establish a clear route from initial concept discussions all the way to manufactured device. This included extensive testing throughout prototyping and pilot-scale manufacturing to ensure instrument and consumable robustness, as well as providing for partial automation of the assembly process to simplify construction. Alongside this, our agile software development made ample provision for interfacing with the Cloud and wearable, client-produced accessories to address the importance of communication within the modern consumer environment.
Early in the COVID-19 crisis, we all saw the potential of this technology to provide fast turnaround assay to identify novel coronavirus infections in distributed healthcare settings. The TTP and DnaNudge teams acted quickly to refine the system for COVID-19 testing. The cartridge was rapidly revised to address an RNA viral assay, by incorporating reverse transcriptase steps, delivering a panel of suitable primers and, most importantly for the safety of those delivering the test, redesigning the system to be fully sealed once the patient sample is injected.
The cartridge and readers were deployed in trials, where they demonstrated clinical feasibility within one month. TTP are manufacturing trial-ready cartridges and supporting DnaNudge during their transition to volume manufacture.