Micronics (Redmond, Washington) reported that it has been issued two patents from the U.S. Patent and Trademark Office (USPTO) for novel microfluidic devices and methods. These new patents relate to the company's focus on the development of rapid and easy to use clinical diagnostic products.
Micronics is developing point-of-care diagnostic tests that may be performed in low cost, disposable devices and that are microfluidics enabled. Using microfluidics, the company is able to substantially reduce the volumes of sample and reagents required to produce a test result, generally within a fraction of the time and cost that traditional reference lab and bench top methods require.
The first newly issued patent has broad applicability for molecular diagnostics. The patent identifies an integrated microfluidic system for isolating, amplifying, and detecting DNA or RNA from biological fluids. All processing steps are done within the microfluidic lab-on-a-card format. The patent is titled "Method and System for Microfluidic Manipulation, Amplification and Analysis of Fluids, for example, Bacteria Assays and Antiglobulin Testing," and is USPTO number 7,416,892 (the '892 case).
In the '892 case, the disposable test may include an embedded membrane that is used to filter out cells and cellular debris. This biological debris is sequestered onto the membrane, lysed, and the DNA or RNA is then amplified using the polymerase chain reaction (PCR) protocol.
In Micronics' molecular diagnostic devices, all reagents required for a diagnostic test generally are incorporated into the disposable device and a low cost method of thermal cycling is applied. In the '892 case, once the DNA or RNA is amplified it is transferred to a lateral flow detection strip, also incorporated within the device, for visual detection. Typical assay time from sample introduction to result is under 20 minutes.
The second newly issued patent relates primarily to microfluidic systems for detecting a person's blood type and Rh status in a sanitary, disposable, credit card-sized device. In addition, the patent is directed to the placement of dried biological agents and liquid buffers into the microfluidic device. This results in a closed system that permits multiple assay steps to be processed without additional human interaction.
Micronics is actively commercializing a device based on this patent for rapid point-of-care determination of donor blood types. The patent is titled "Microfluidic devices for fluid manipulation and analysis," and is USPTO number 7,419,638.
Micronics develops near-patient molecular and immunohematology diagnostic tests that allow real-time answers to health questions while at the physician's office, in the emergency room, or wherever rapid and accurate test results are informative to health status, disease detection and patient care.