Outline of Business Plan
This project uses the Open Innovation Business Model (OIBM), which enables the creation of diagnostic safety net - the critical part of infrastructure, which is necessary for combating naturally occurring diseases and preventing epidemics
Summary: A new type of industrial endeavor, this project has a social impact that goes far beyond commercial goals of typical diagnostics. 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 and will not help to prevent epidemics.
If a commercial goal is pursued in this endeavor, it will result in a diagnostic tool that is not affordable for home use. Therefore, this project seeks financial support of The Giving Pledge members and similarly positioned individuals to cover the costs of the diagnostics development and establishing the manufacturing facilities. Partially, the costs can be covered by the US government grants.
TIRF Labs envisions that a robust diagnostic device for home use will be one of the central parts of the non-commercial infrastructure, which will prevent the spread of infections. The COVID-19 pandemic demonstrated the necessity of affordable diagnostics. TIRF Labs proposes a device called iDiagnostics, or individual diagnostics, that is based on a platform technology, which can be rapidly applied to new pathogens by “dropping in” specific information about the organism. The device will be critically important for many healthcare areas, including prevention and combating epidemics, early detection of cancer, cardiovascular, and neurological diseases, food and water safety, biodefense, forensic, environmental, and agricultural analyses.
TIRF Labs has prototyped and tested the iDiagnostics device and is seeking funds to refine the handheld iDiagnostics into a platform technology for thousands of healthcare applications. Together with the handheld device, TIRF Labs is offering the broad range of development tools to facilitate all stages of diagnostics development from biomarker discovery to assay validation and testing.
We envision that the project will result in creating of a new professional network, which will unite diagnostics research community, medical doctors, other healthcare professionals, administrators, businessmen, and grassroots enthusiasts. To achieve these goals, TIRF Labs uses Open Innovation Business Model (OIBM). OIBM will stimulate the exchange by ideas, intellectual property, and know-how, to enable interdisciplinary innovations and incorporation of existing and emerging techniques into the iDiagnostics platform.
The project will be performed in two phases. Phase 1 of the project will consolidate efforts of significant part of the scientific diagnostics community. 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. A significant part of Phase 1 effort will be devoted to the development of a family of sample preparation modules that can be added to iDiagnostics platform seamlessly, similar to LEGO blocks.
In parallel, we will refine the handheld prototype of iDiagnostics into a robust device for home use. We plan to transform the first prototype into a robust iDiagnostics product well-suited for home use by minimally trained individuals, similar to a pregnancy test strip. We will explore the possibility of including a cellphone camera and a processor into the cradle in order to make iDiagnostics simpler and optimally user-friendly. TIRF Labs is seeking $4 million to perform the Phase 1 effort.
In Phase 2, in 12-18 months after the beginning of Phase 1, 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. By the middle of Phase 2, we will have a well-refined iDiagnostics product ready for distributing. For Phase 2, which involves the development of four groups of applications of iDiagnostics, refining the prototype for home use, and laying the foundation for the biological safety network, TIRF Labs is seeking $20 million.
As mentioned above, this project does not pursue a commercial goal. We envision a large social impact of our endeavor for the entire mankind and, therefore, address our request for funding to The Giving Pledge members and similarly positioned individuals. The mission of this project is to create diagnostic tools for biological safety infrastructure by making the handheld precision diagnostics available and affordable to everyone. It is very much-needed, critical tool for combating current and preventing future pandemics.
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 for numerous point-of-care applications. 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. Most of these applications will benefit tremendously from the opportunity to perform analyses almost instantaneously and obtain the results in 2-10 minutes.
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 in BAA and SBIR awards. We were productive with government funds and 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). Over a hundred research groups worldwide acquired our TIRF products, generated unique research data analyzing the mechanisms of biological phenomena at the level of single molecules. Several of TIRF Labs’ customers are awaiting the iDiagnostics application development tools, which we envision to produce in Phase 1.
Risks and challenges
TIRF Labs has been working on molecular diagnostics methods for the last fourteen years and has created a family of TIRF instruments, including bench-top and portable TIRF biosensor instruments. The latter have been tested in research groups of our customers and used for generating unique insights about the mechanisms of biomolecular interactions. The handheld real-time TIRF microarray biosensors have been prototyped and tested in our laboratory and research groups of our collaborators. Risks and challenges in this are appear to be minimal. We have assembled a group of scientists and engineers with vast experience in all relevant fields. However, a project of such scale as iDiagnostics involves new risks. To mitigate the risks of transition to clinical analyses, we are offering to the entire biodetection community uTIRF biodetection station and iDiagnostics Application Development Kits (ADK) in the framework of Open Innovation Business Model (OIBM). The OIBM allows for minimizing the risks associated with the transition to clinical applications. Using of uTIRF-ADK will involve a number of diagnostics research groups with their own networks, which will facilitate the entering of iDiagnostics into the conservative area of clinical analyses. The research and development of uTIRF and iDiagnostics have worked, and the prototyping and low-volume manufacturing of these products has been done. Now, a group of risks will be associated with the transition from low-volume manufacturing to volume production. To mitigate these risks, we are establishing parallel contacts with alternative manufacturing partners and collaborators to assure multiple possible channels for production. If a setback does arise in one of the channels, we will use an alternative channel. iDiagnostics is a sophisticated technology. We are using a number of unique methods and production technologies. We believe that we are able to foresee and minimize risks associated with these methods in order to deliver uTIRF and iDiagnostics ADK to our customers with full satisfaction. Keeping our existing and prospective collaborators and customers updated about our progress and receiving feedback from them is our priority.
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 detection of COVID-19 and other infectious diseases, 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.