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Thermal Gradient Enters Commercial Prototype Testing Phase

RICHMOND, VA – Thermal Gradient has received the first commercial prototypes of its FlashDirect nucleic acid (DNA/RNA) testing instrument. The instruments are undergoing validation testing at the company’s new facility at the Virginia Biotechnology Research Park in Richmond, VA.

The basic FlashDirect platform is ideally suited for the point-of-care market and will be available in three variants, FlashAmp, FlashDirect-LC, and FlashDirect-HC. All three share these common attributes:

  • Small footprint, 5in x 7in (13cm x 18cm )

  • Rapid qPCR, typically 2-8 minutes for 40 cycles

  • Inexpensive, single use, disposable cartridge

  • Optionally powered from an internal battery

  • Multi-channel fluorescence detection for traditional qPCR curves and thermal melt

  • Wirelessly controlled by iPAD or Windows tablet

FlashAmp is a variant of the FlashDirect family that will address the non-diagnostic market. It will provide researchers with the ability to perform rapid quantitative PCR from separately prepared samples.

The FlashDirect-LC version of the instrument and cartridge is a complete sample-to-answer system that provides diagnostic results from low complexity specimens such as throat and nasal swabs, and saliva. Developed with MRSA as the primary test, the system is capable of virtually any nucleic acid based target from this class of specimen. The FlashDirect-LC platform will also be adapted for bioDefense and forensic applications.

FlashDirect-HC system provides the sample-to-answer diagnostic results from higher complexity specimens such as serum and plasma. The company has been focusing this variant on the HIV and similar testing markets.

Once this testing phase is complete, Thermal Gradient will refine the design and software for manufacturing and product launch. They are currently in discussions with several potential strategic and distribution partners.

“We are extremely excited to have reached the point where we incorporating our exceptional molecular testing capabilities in commercial products. We believe that they will make a huge difference in the point-of-care detection of HIV, Malaria, Influenza, MRSA and for other targets where high sensitivity and short test times are critically important,” said CEO Robert Juncosa.

About Thermal Gradient

Thermal Gradient relocated to the Virginia Biotechnology Research Park in Richmond, Virginia from Rochester, New York in October 2015. Thermal Gradient develops devices and systems for rapid molecular diagnostics based on their proprietary thermal cycling and nucleic acid extraction technologies. They are presently developing products for nucleic acid testing research and infectious disease detection and are pursuing collaboration, licensing and other strategic opportunities.

Thermal Gradient wishes to acknowledge the continuing support from NIH for the development of a field deployable HIV detection and monitoring system. It is under this program that the recent advances were made.

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