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iDiagnostics® for All

The Handheld Future of Precision Medicine

In collaboration

with TIRF Labs

www.tirf-labs.com

info@tirf-labs.com

919.463.9545

Business Plan
Open innovation business model creates iDiagnostics safety net
to combat naturally occurring diseases and to prevent man-made epidemics

The project will be performed in two phases. In Phase 1, TIRF Labs will supply the uTIRF Biodetection Station and iDiagnostics Application Development Kit (ADK) to other research groups that are working in the area of molecular diagnostics. The ADK and uTIRF will facilitate the initial stages of the diagnostic cycle, i.e. creating panels of biomarkers, assay development and validation, and clinical testing. In Phase 2, which will start in 18-24 months after the beginning of Phase 1, we will start manufacturing iDiagnostics devices and after FDA approval begin supplying them to all interested parties, including the general public.
Phase 1 and Phase 2. On Phase 1 of this project , we will distribute the development tools: ultimate TIRF station - uTIRF, Application Development Kit  (ADK) , share the methods and offer technical and methodological services to our collaborators and customers. In parallel, we will refine the prototype of the handheld iDiagnostics into robust product for home use. In Phase 2 we and our manufacturing collaborators will begin offering the iDiagnostics sensors and cartridges to specialists and general public, upon FDA approvals of respective tests.
Although the uTIRF Biodetection Station is a new product, several research groups worldwide have requested this product along with iDiagnostics ADK for their studies. Distributing uTIRF-ADK and other development tools and methods, we will keep in mind that the ultimate goal of the iDiagnostics project is to create a decentralized precision diagnostics affordable for all. Fig. 1 shows an early prototype of iDiagnostics and disposable cartridges. In Phase 1, we plan to transform the first prototype into a robust iDiagnostics product well-suited for home use by minimally trained individuals, similar to pregnancy test strip.  In Phase 1 we will explore the possibility of including  a cellphone camera and a processor into the cradle in order to make iDiagnostics simpler and maximally user-friendly. By the middle of Phase 2 we will have a well-refined iDiagnostics product ready for manufacturing.
Despite its small size and low cost, iDiagnostics will be an analytical device as powerful as a bench-top laboratory instruments. It also will be used by medical doctors, first responders, clinical researchers, and other specialists. We anticipate that several months after we receive the necessary funds, a number of tests for laboratory use - including food safety, allergens in food, prostate cancer, and breast cancer - will be developed, validated, and used for research purposes in academic, government, and industrial research groups.  
To further develop the applications of iDiagnostics, to refine the prototype for home use, and to lay the foundation for the biological safety network, TIRF Labs is seeking $24 million. This project does not pursue a commercial goal. We envision a large social impact of our endeavor and address our request for funding to The Giving Pledge members and similarly positioned individuals. We also address our appeal to the US government. The mission of this project is to create diagnostic tools for biological safety infrastructure by making the handheld precision diagnostics available to everyone. It is very much-needed for combating current and preventing future pandemics.
TIRF Labs team of scientists and engineers has been productive with prior government funding. In 2004-2012, the US government granted $4.3 million to TIRF Labs; we developed a family of scientific instruments for microscopy and spectroscopy, including the advanced biodetection platform technology - real-time TIRF microarrays, which created the basis for iDiagnostics. We developed, prototyped, and tested iDiagnostics using our own income generated from sales of our TIRF products. Currently, TIRF Labs is the sole source of advanced TIRF instruments (see www.tirf-labs.com) We are seeking $24 million to make iDiagnostics massively manufactured and available to everyone. We believe that iDiagnostics endeavor is of paramount importance for combating and preventing epidemics/pandemics, as well as for thousands of other applications.
We envision that Phase 1 of iDiagnostics project will consolidate efforts of a significant part of the scientific diagnostics community. In Phase 1 of our project, we will distribute the following iDiagnostics development tools to our collaborators: 1) ultimate TIRF biodetection station - uTIRF, 2) Application Development Kit  (ADK), 3) we will share the methods, experimental protocols, reagent kits and supplies, and 4) offer technical and methodological services to thousands of research groups worldwide. They will be using uTIRF stations to interface their existing bioassays with iDiagnostics platform and develop new assays and new applications. In parallel, we will refine the handheld prototype of iDiagnostics into a robust device for home use.
In Phase 2, we and our manufacturing partners will begin offering the handheld iDiagnostics and cartridges to specialists and the general public, upon FDA approvals of respective applications.  More about the business plan here.
Our analysis shows that the envisioned diagnostics for large-scale coverage applications cannot be developed in the typical commercial pipelines of venture capital, merger and acquisition (M&A), or other for-profit pursuits that would yield a commercial scheme. A high-cost device driven by for-profit motivation is not suited to the general public. We believe that the development stage of the project should be funded by The Giving Pledge, similarly positioned individuals, the government, or by the public itself. Join the fight: learn more about becoming a collaborator or donate to our project.