iDiagnostics - the handheld future of precision medicine; Single Molecule Detection, Single Cell Analysis, Cell Membrane Studies, TIRF microscopy, TIRF accessories for fluorometers, TIRF biosensor instruments, Real-time TIRF microarrays, and more>>> visit www.tirf-labs.com
Molecular iDiagnostics for Home Use
by TIRF Labs
Neither human subjects nor laboratory animals are involved in this project. Genetically modified organisms and biologically hazardous materials are also not involved. Our collaborators, who do perform regulated studies, carefully comply with the respective government protocols and rules.
The field of lifesciences, in general, and the area of molecular biology, in particular, operates with powerful technologies that have strong potential for improving quality of our life. However, these powerful tools, if used improperly, can cause adverse effects. We believe that scientists should be responsible for results of their studies. It is our company policy and responsibility of our workers to foresee possible adverse effects of our studies and adhere to the highest ethical standards to avoid possible adverse effects. We do not develop and do not support the development of controversial biological applications.
Compliance with FDA Guidance
TIRF Labs complies with the U.S. Food and Drug Administration guidance, including the following:
The Software guidance documents http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089543.htm
Design Considerations for Devices Intended for Home Use
Guidance for Molecular Diagnostic Instruments with Combined Diagnostic and Research Functions
We are grateful to the National Institutes of Health, Mr. Michael Astrachan - XVIVO Scientific Animation, Genome British Columbia, The Howard Hughes Medical Institute, and Dr. David Goodsell, The Scripps Research Institute, for their kind permissions to use their videos and images.
Risks and challenges
TIRF Labs has been working on molecular diagnostics for the last fourteen years and has created a family of TIRF instruments, including bench-top, portable, and handheld TIRF biosensors. 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 biodetection community uTIRF biodetection station and iDiagnostics Application Development Kits (ADK). 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.