Diagnostic Platform
Making diagnosis simpler, faster, and more accurate.
Point-of-care diagnostics is a field just beginning to hit its stride, according to many in the industry. Advances in microfluidics, lab-on-a-chip methodologies, miniaturization of testing methods and improvements in detection technologies are leading the way. Beyond the technological standpoint, many also are seeing a paradigm shift of recognizing the validity of testing away from the centralized laboratory and more into arenas such as physician offices, emergency rooms, and even home testing transmitted directly to physicians. From bedside to battlefield, point-of-care diagnostics also represents one solution to helping solve a major healthcare challenge: how to do more with less.
Simple Onestep Nucleic Acid Extraction Device
Currently available nucleic acid testing (NAT)-based assays are complex and time-consuming, and they require expensive instrumentation and dedicated laboratory spaces for sample preparation as well as for amplification and detection of the nucleic acid target. Reagents required for these tests are also expensive and must be transported and stored refrigerated or frozen. These characteristics have limited the use of such assays for point-of-care (POC) testing, especially in resource-poor settings. Efforts to develop simple and rapid NAT-based assays have focused predominantly on the amplification and detection steps, with sample preparation and nucleic acid extraction remaining the bottleneck in the development of NAT systems suitable for POC applications or resource-limited settings. A review of NAT platforms and technologies currently under development and validation for rapid field testing revealed that, in addition to requiring expensive and complex instrumentation, many of these systems also require off-line sample preparation and reagent handling. In their current format, they are therefore not appropriate for POC testing in resource-limited settings.
None of the current methods or any commercially available RNA and DNA sample preparation kits meet the challenging demands of Point of Care amplification tests.
While there have been significant advances in miniaturization of amplification devices, there is an unmet market need for a simple, accurate and user-friendly disposable Point-of-Care nucleic acid amplification device that can be implemented in resource limited environment.
“PCR on a Card” is a patented lateral flow technology that allows printed heating elements and sprayed-on, dried reagents, where capillary action draws sample up the card past heating elements, creating a cycling effect. As liquid moves, nucleic acids are amplified, picking up super-fluorescent lanthanide nano-particles along the way. Low cost reader uses LED. Lanthinide nano-particles have no auto fluorescence due to broad stokes shift. Entire process takes minutes and cost is estimated at $ 1.00 manufacture – list $5-25/test.
Patent number: US10597651
Abstract: The present disclosure relates to nucleic acid extraction and purification methods and devices to accomplish the same. The present disclosure proposes a novel approach to this problem wherein cell isolation and nucleic acid purification can be integrated in a single “step,” by using the same solid phase for both cell adsorption and nucleic acid purification. This is achieved by binding the cells to a solid support as a first step. The same solid support is then used under conditions that lyse the bound cells, and then subsequently enable the nucleic acid to bind to the support. Methods of the present disclosure relate to the isolation of nucleic acid, and especially to a method for isolating DNA from cells, biological or environmental samples using antibiotics, which bind nucleic acids.
Filed: April 29, 2015
Issued: March 24, 2020
Inventor: Raveendran Pottathil
POC for Molecular Diagnostics Test
AccuDx develops customized tests for a variety of lead biotechnology companies.
Fully automated systems for molecular diagnostics have been developed but are extremely expensive and complex. Currently molecular diagnostics are limited to those who can afford $200+ per test and complex labs with the skills to run them. There is a need in the marketplace for a reasonably priced fully integrated molecular diagnostic system that will address cost and ease of use
Disposable Thermocyclers
AccuDx developed a rapid thermocycler on a card technology that will amplify and detect targeted genetic material faster, easier and cheaper and change the paradigm taking DNA testing from a specialized procedure to a routine test.
AccuDx developed a rapid thermocycler on a card technology that will amplify and detect targeted genetic material faster, easier and cheaper and change the paradigm taking DNA testing from a specialized procedure to a routine test. AccuDx has developed a “PCR on a Card”, a patented lateral flow technology that allows printed heating elements and sprayed-on, dried reagents, where capillary action draws sample up the card past heating elements, creating a cycling effect. As liquid moves, nucleic acids are amplified, picking up super-fluorescent lanthanide nano-particles along the way. “PCR on a Card” meets these needs. Low cost reader uses LED. Lanthanide nano-particles have no auto fluorescence due to broad stokes shift. Entire process takes minutes and cost is estimated at $ 1.00 manufacture – list $5-25/test.
The initial target market will be biowarfare/bioterrorism detection closely followed by clinical diagnostic and life science R&D markets followed by other industrial applications.
Patent number: 7179639
Abstract: This is a self-contained disposable thermal cycler device in which target sequence is amplified as the samples passes over a grid of alternating temperature and then at the completion of the reaction, the amplified material is captured by probes complementary to the targeted sequence. Since the device can be sealed and is disposable, it reduces the occurrence of cross contamination or specimen carry-over.
Type: Grant
Filed: March 5, 2003
Date of Patent: February 20, 2007
Inventors: Raveendran Pottathil, Jerome Anton Streifel