Product Development
Thermal Gradient has several product development initiatives underway intended to address a variety of markets and applications.
Quick Flash
Availability: Q4 2012
Based on our third generation ultra-fast PCR device, the Quick Flash product line is intended to address the research and laboratory markets. The Quick Flash single use disposable cartridge and simple to use benchtop processing module brings Thermal Gradient's fast PCR into the general research laboratory. Researchers and developers of nucleic acid assays will be able to perform PCR in minutes in single or low throughput workflow settings.
The prepared PCR mix is first dispensed into the inlet side of the dual cuvette cartridge which is then placed into the processing module. Minutes later the amplified sample is available in the outlet cuvette.
Quick Flash cartridges will be available in a variety of PCR protocols such as two or three temperature PCR and 20 to 40 cycles of amplification.
Flash Light
Availability: TBD
Flash Light will be an extension fo the Quick Flash product line. Also single use and disposable, the Flash Light cartridges will contain Thermal Gradient's realtime PCR devices. These cartridges, when used in the companion benchtop processing module, will allow researchers to perform quantitative PCR in minutes.
Flash Remote
Availability: TBD
Flash Remote is Thermal Gradient's most ambitions product development effort. Supported by NIH funding, Thermal Gradient is developing a "field deployable" system that will bring HIV testing to "resource limited settings" such as sub-Saharan Africa. This system will allow testing for diagnosis and on-going viral load monitoring within 30 minutes of access to the patient.
The heart of this system is the Flash Cartridge. A little larger than the human thumb, it is a complete, disposable sample-to-answer test device, combining nucleic acid extraction and purification with quantitative PCR amplification.
The integrated design includes:
- On-board sample preparation and PCR reagent storage
- A reaction chamber where nucleid acid extraction and purification is performed
- Thermal Gradient's quantitative PCR device
- On-board waste management
The Flash Cartridge delivers a molecular diagnostic test result in about 30 minutes allowing clinicians to diagnose and make treatment decisions in the same patient visit. The simplicity of the Thermal Gradient technology allows the instrument to be flexible, inexpensive, compact, and usable by minimally trained medical workers in field settings.
The issues being addressed by the current program are world-wide health problems, particularly in low resource settings. About 10% of the 25 million HIV positive people in these conditions are receiving anti-retroviral therapy and the number is growing but they and their communities are at grave risk because the means do not exist to monitor their viral loads effectively. Therapeutic non-compliance and spontaneous mutation of HIV strains will cause patients to first become infectious and then progress to AIDS. The TG system answers the need for fast, point-of-care viral load monitoring. It also provides field clinicians with the ability to screen infants up to 18 months old who are born of at-risk mothers. The addition of a TB test to the platform will address the additional problem of co-infection of HIV and TB, a situation resulting in half the world-wide deaths among AIDS patients.