DEVELOPMENT KITS TO CREATE A DIAGNOSTIC PATHOGEN, PEST, OR SPECIES
The planet suffers due to a lack of effective diagnostic assays.
Effective diagnostics are required at the frontlines for many fields where molecular insight is required for detection and measurement of DNA, RNA, proteins, and other indicators. In principle, the development of nucleic acid tests for diagnosis should be ‘low hanging fruits’. However, the lack of laboratory capacity to run molecular tests, the failure to develop new highly specific and sensitive tests, the lack of standardization of test formats, and the failure to develop platforms that deliver diagnostics in the places where they are most needed, prevent deployment of diagnostics for biosurveillance on the scale needed by most programs.
By creating a new, collaborative model for diagnostics development, we can address the need for low-cost, field-based diagnostics across a broad gamut of use cases, including combating wildlife trade, identifying new pests and pathogens, monitoring plant and animal species, and ensuring the sustainability of supply chains.
We propose that by using a combination of the the NABIT (Nucleic Acid Barcode Identification Tool), a rugged, hand-held, battery-powered, highly specific and sensitive instrument that is accessible to anyone, anywhere, at any time – in tandem with an open, simplified, accelerated pathway for creating diagnostics, we can make molecular diagnostics accessible on a global scale for every pathogen, parasite, or species, that needs one.
By making diagnostic tools accessible to all – anywhere, at any time, by anyone – we can get ahead of the challenges that face us from emerging pathogens and their threat to human health, agriculture, and biodiversity. And by harnessing planetary genius through collaboration to translate lab-based diagnostics to NABIT tests on frontlines of where they are needed, we can address the problem of neglected diagnostics at scale.
Molecular development kits (MDKs)
We are designing a Molecular Development Kit (MDK) to accelerate and even automate the translation of new tests to be developed for use with the NABIT. The MDKs will allow anyone to co-create and co-develop field-ready, customized diagnostic tests with us.
Specifically, the MDK facilitates the transfer of a lab-based assay – the recipe of primers and chemistries – to work on our hand-held molecular platform consisting of the NABIT hardware, and compatible, all-inclusive cartridge test kits. Our goal is to make this process as simple and standardized as possible, including allowing molecular “developers” to change the user interface, and instructions specific to their tests.
Our MDKs will provide a sample of available cartridges, kit components, and recommended buffers to facilitate this process for 3rd party developers, along with the NABIT hardware. We will also provide supporting software tools to guide developers through the process of determining and designing assay targets and setting parameters on NABIT hardware. Tutorials and documentation will be provided as well as support services from our molecular and engineering teams to support aspects of development that third party developers may be lacking.
Upon completion, MDK partners will have ownership over a custom, shelf stable, diagnostic test (including a license to the cartridge) ready to be deployed on our portable, field-hardened, platform, anywhere in the world – including the most remote places where diagnostics are needed most.