Patent for Sale:

Microfluidic Point-of-Care Diagnostics Platform    

Broad technology and patent portfolio capable of unlocking a wide range of applications in medical diagnostics utilising low-cost microfluidic platforms which don’t require any external equipment

Overview

Based on a deep-understanding of core microfluidics, biochemistry, materials science and high-volume manufacturing a range of technologies have been developed which are able to be used in the medical in-vitro diagnostics (IVD) market. The technology’s core USP is its ability to provide high quality diagnostic results quickly on fully disposable systems that are inherently designed for low cost manufacture. The platforms are capable of doing this by being engineered to precisely move fluids through small channels without the need for any external equipment, and this allows for access to use-settings and price points previously unattainable.

Traditional IVD tests are conducted in large hospital laboratories which deal with huge numbers of tests from across a wide range of patients and healthcare centres. However, in many specific situations there is a clear need to conduct testing quicker and nearer the patient to give results back to the physician and save valuable time in triaging. As such, the field of Point-of-Care Testing (PoCT) has grown rapidly over the last decade with large IVD companies investing heavily in this area. Typical PoCT options require a hardware unit and cartridges to run specific tests on the patient, however, this can be problematic due to the cost and maintenance of the hardware equipment, along with the requirement to locate the specific test system at the point of requirement. The technology developed here allows for tests to be conducted on single-use, disposable cartridges which do not require any hardware equipment and therefore have the clear benefits of rapid turnaround time, low-cost per test, and true portability. These benefits make the technology ideal for use in emergency testing, primary care centres, on-site visits, and resource-constrained settings.

Primary Application of the Technology

This technology is primarily focused on the Point of Care Testing (POCT) market which enables quicker and more cost-effective diagnosis. The POCT market is estimated to be worth >$8 billion p.a and growing at ~8% p.a. For POCT, beneficial market growth drivers include an ageing population, growth in lifestyle disorders, the need for rapid results at low cost, the emergence and re-emergence of many infectious diseases, and the suitability of POCT approaches for developing countries where there is limited healthcare infrastructure. The technology platforms are adaptable to much of the overall POCT market, and as a minimum has utility and benefits compared to existing technologies across approximately $5 billion p.a. market.

The Problem Solved by the Technology

It removes the need for expensive additional equipment by condensing all elements required for a diagnostic test on to a single use disposable system.

How the Technology Solves the Problem

The technology uses world-leading microfluidic design, material modifications, low-cost plastic manufacturing and novel biochemistry to minimise the requirements for the test, and therefore allow for such low-cost components that they can be disposed.

Competitive Advantage

Typical PoCT options require a hardware unit and cartridges to run specific tests on the patient, however, this can be problematic due to the cost and maintenance of the hardware equipment, along with the requirement to locate the specific test system at the point of requirement. The technology developed here allows for tests to be conducted on single-use, disposable cartridges which do not require any hardware equipment and therefore have the clear benefits of rapid turnaround time, low-cost per test, and true portability.

Additional Information

There are a wide variety of components which demonstrate the technology available, including over 1000 microfluidic platforms. There is a large quantity of other materials available for sale to go along with the intellectual property, including:
- Documentation – the devices have been developed for specific applications and have robust ISO13485 documentation and data
- Equipment – key bespoke equipment including ~30 high quality injection mould tools, device prototyping production equipment and data analysis packages
- Within this field of technology a recognized Trademark

Patent Summary

U.S. Patent Classes & Classifications Covered in this listing:

Class 435: Chemistry: Molecular Biology And Microbiology

This class provides for the following subject matter when not provided for elsewhere: A process of using a microorganism or enzyme to synthesize a chemical product. A process of treating a material with a microorganism or enzyme to separate, liberate, or purify a preexisting substance. An in vitro process of measuring and testing in which: (1) A microorganism or enzyme is used to determine the presence or identity of a compound or composition in a sample; (2) A microorganism is identified by propagation; (3) An enzyme is identified by its catalytic activity; (4) The presence of microorganisms is detected; (5) A live microorganism is used in an antigen antibody test as an antigen; (6) Fixed or stabilized nonliving microorganisms, cells, or tissues are involved. A process of propagating a microorganism. A process in which the genetic structure of a microorganism or extrachromosomal genetic structure is altered. A process of organ or tissue maintenance. A process of mashing or malting. Microorganisms, per se, or the subcellular parts thereof. Enzymes, immobilized enzymes or enzyme containing compositions not otherwise provided for and the processes for purifying enzymes or forming immobilized enzymes. Compositions claimed or solely disclosed as for the propagation of microorganisms or for measuring and testing processes. Using microorganisms to destroy hazardous or toxic waste.

Subclass 13: Involving blood clotting factor (e.g., involving thrombin, thromboplastin, fibrinogen, etc.)
Subclass 287.1: Including measuring or testing
Subclass 287.2: Measuring or testing for antibody or nucleic acid, or measuring or testing using antibody or nucleic acid
Subclass 287.7: Including bibulous or absorbent layer
Subclass 287.8: Including multiple, stacked layers
Subclass 288.5: Including means for fluid passage between compartments (e.g., between wells, etc.)
Subclass 34: Determining presence or kind of micro-organism; use of selective media
Subclass 7.93: Competitive assay

Class 422: Chemical Apparatus And Process Disinfecting, Deodorizing, Preserving, Or Sterilizing

This is a generic class for (1) processes of disinfecting, deodorizing, preserving or sterilizing and (2) apparatus for (a) carrying out chemical reactions, (b) preparing or treating chemical compounds or compositions even though only a physical reaction is discernible, (c) performing an analysis which involves either a chemical reaction or a physical reaction not elsewhere provided, for and (d) carrying out the above processes not elsewhere provided for.

Subclass 68.1: Means for analyzing liquid or solid sample
Subclass 69: Sorption testing
Subclass 73: With coagulometer for agglutination, clotting, or prothrombin, or for particle (e.g., cell, etc.) counting, or volume or characteristics determination

Class 436: Chemistry: Analytical And Immunological Testing

This is the generic class for: chemical test standards, analytical compositions, and processes which involve a chemical reaction for determining qualitatively or quantitatively the presence of a chemical element, compound or complex in a composition or a chemical compound, or an element or radical in a compound; processes for analysis which involve an in vitro antigen-antibody, immunological or protein binding interaction other than those involving a living antigen, or enzyme label; and processes of analysis or study of the chemical properties of a sample; the physiological effect of a sample; or chemical determination of a physical property of a sample. Compositions and their mere methods of use of thermoparticulating compositions. Combinations of tests or measurements with methods of regulating a chemical reaction not otherwise provided for in a chemical synthesis class or otherwise.

Subclass 180: Volumetric liquid transfer
Subclass 501: BIOSPECIFIC LIGAND BINDING ASSAY
Subclass 514: INVOLVING DIFFUSION OR MIGRATION OF ANTIGEN OR ANTIBODY
Subclass 518: INVOLVING AN INSOLUBLE CARRIER FOR IMMOBILIZING IMMUNOCHEMICALS
Subclass 536: INVOLVING IMMUNE COMPLEX FORMED IN LIQUID PHASE
Subclass 538: Separation of immune complex from unbound antigen or antibody
Subclass 69: CLOTTING OR CLOTTING FACTOR LEVEL TESTS
Subclass 70: SEDIMENTATION RATE OR HEMATOCRIT