ITHACA, N.Y. \u2014 Rheonix Inc., a developer of fully automated molecular diagnostics solutions, has been\u00a0granted patent 9,132,398, \u201cIntegrated Microfluidic Device and Methods,\u201d for the Rheonix CARD\u00ae\u00a0cartridge, which enables assays to be performed on the company\u2019s EncompassMDx\u00ae and Encompass\u00a0Optimum\u2122 instruments. The CARD, which stands for Chemistry and Reagent Device, will make\u00a0molecular diagnostics simpler and easier to perform through an innovative and functional design that\u00a0delivers a fully automated molecular assay at a fraction of the cost of other options. All assay steps are\u00a0performed within the fully enclosed cartridge, thus eliminating the potential for contamination, reducing\u00a0user error, and streamlining workflow.<\/p>\n
The CARD\u2019s design enables adoption of advanced molecular technology by laboratories of all types, from\u00a0small community hospital labs to highly complex, centralized laboratories. The design also facilitates\u00a0implementation across a wide range of market opportunities, including next-generation sequencing (NGS)\u00a0sample prep, research-use-only testing, food and beverage industry applications, and in vitro diagnostics.<\/p>\n
The \u2019398 patent allows researchers and clinicians to quickly, easily, and cost-effectively run several\u00a0samples through a fully integrated and automated nucleic acid amplification test, from raw sample input\u00a0through detection, with no user intervention. Each CARD allows for simultaneous testing of four different\u00a0samples and can handle a broad range of sample types, such as fresh tissue, urine, whole blood, serum,\u00a0saliva, swabs, and formalin-fixed, paraffin-embedded (FFPE) tissue. The Rheonix CARD performs\u00a0multiple molecular techniques, including sample preparation, such as chemical and enzymatic lysis and\u00a0DNA purification; amplification, such as endpoint polymerase chain reaction (PCR), reverse transcriptase\u00a0PCR, and quantitative PCR; and detection on a low-density microarray or lateral flow strip.<\/p>\n
\u201cThe \u2019398 patent recognizes the groundbreaking achievement we have reached with the Rheonix CARD.\u00a0From the device\u2019s hardware to its process, it will help make molecular diagnostics a reality in laboratories\u00a0worldwide,\u201d said Tony Eisenhut, president of Rheonix. \u201cWith the lowest cost of ownership of any\u00a0molecular platform, the patent confirms the novelty of the Rheonix approach to molecular diagnostics.<\/p>\n
Where other systems have traditionally emphasized either multiplex or throughput, Rheonix has designed\u00a0single-use cartridges that do both and can perform sophisticated functions with a simple design. This\u00a0lowers laboratory costs by eliminating waste in time, equipment and consumables, and reduces the \u00a0mount of highly skilled labor. Rheonix is helping bring powerful molecular tools to laboratories that could\u00a0not previously afford to purchase or run them.\u201d<\/p>\n
The dual-layer design of the Rheonix CARD automatically manipulates reagents internally with its active\u00a0fluidic network of pumps, valves and channels. The upper surface of the CARD contains reservoirs that\u00a0hold reagents used in the extraction, purification, amplification and detection process and any resulting\u00a0liquid waste. The channels and pumps located on the lower surface of the CARD are used to transport\u00a0and mix reagents and move wastes into the reservoirs on the top. By actively pumping fluids from\u00a0reservoir to reservoir within the CARD, molecular diagnostic tests can be performed automatically.<\/p>\n