Micronics, Inc. today
announced that it has been issued two patents from the United States 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 entitled “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 entitled “Microfluidic
devices for fluid manipulation and analysis,” and is USPTO number 7,419,638.