Rheonix receives patent for device and process that will improve workflow and lower costs of molecular diagnostic testing

Rheonix Inc., a developer of fully automated molecular diagnostics solutions, has been granted patent 9,132,398, “Integrated Microfluidic Device and Methods,” for the Rheonix CARD® cartridge, which enables assays to be performed on the company’s EncompassMDx® and Encompass Optimum™ instruments. The CARD, which stands for Chemistry and Reagent Device, will make molecular diagnostics simpler and easier to perform through an innovative and functional design that delivers a fully automated molecular assay at a fraction of the cost of other options. All assay steps are performed within the fully enclosed cartridge, thus eliminating the potential for contamination, reducing user error, and streamlining workflow.
The CARD’s design enables adoption of advanced molecular technology by laboratories of all types, from small community hospital labs to highly complex, centralized laboratories. The design also facilitates implementation across a wide range of market opportunities, including next-generation sequencing (NGS) sample prep, research-use-only testing, food and beverage industry applications, and in vitro diagnostics.  
The ’398 patent allows researchers and clinicians to quickly, easily, and cost-effectively run several samples through a fully integrated and automated nucleic acid amplification test, from raw sample input through detection, with no user intervention. Each CARD allows for simultaneous testing of four different samples and can handle a broad range of sample types, such as fresh tissue, urine, whole blood, serum, saliva, swabs, and formalin-fixed, paraffin-embedded (FFPE) tissue. The Rheonix CARD performs multiple molecular techniques, including sample preparation, such as chemical and enzymatic lysis and DNA purification; amplification, such as endpoint polymerase chain reaction (PCR), reverse transcriptase PCR, and quantitative PCR; and detection on a low-density microarray or lateral flow strip.
“The ’398 patent recognizes the groundbreaking achievement we have reached with the Rheonix CARD. From the device’s hardware to its process, it will help make molecular diagnostics a reality in laboratories worldwide,” said Tony Eisenhut, president of Rheonix. “With the lowest cost of ownership of any molecular platform, the patent confirms the novelty of the Rheonix approach to molecular diagnostics. Where other systems have traditionally emphasized either multiplex or throughput, Rheonix has designed single-use cartridges that do both and can perform sophisticated functions with a simple design. This lowers laboratory costs by eliminating waste in time, equipment and consumables, and reduces the amount of highly skilled labour. Rheonix is helping bring powerful molecular tools to laboratories that could not previously afford to purchase or run them.”
The dual-layer design of the Rheonix CARD automatically manipulates reagents internally with its active fluidic network of pumps, valves and channels. The upper surface of the CARD contains reservoirs that hold reagents used in the extraction, purification, amplification and detection process and any resulting liquid waste. The channels and pumps located on the lower surface of the CARD are used to transport and mix reagents and move wastes into the reservoirs on the top. By actively pumping fluids from reservoir to reservoir within the CARD, molecular diagnostic tests can be performed automatically.