Technology - A Rapid, High Content, Reagent Sparing, Fluorescent Plasmonic Assay Platform for Multiplexed Serum Antibody Detection in Lyme Disease and COVID-19

A Rapid, High Content, Reagent Sparing, Fluorescent Plasmonic Assay Platform for Multiplexed Serum Antibody Detection in Lyme Disease and COVID-19

A protein microarray, in the form of a compact biochip, that can be analyzed with high sensitivity using GC-FP technology.

Background:

Some infectious diseases are easy to diagnose, but others are much more difficult. One example is Lyme disease (B. burgdorferi), which is caused by a slow-growing organism that takes many weeks to detect. Current testing is sub-optimal and confusing due to a high false negative rate; patients may be quite ill but appear normal on testing, and physicians may elect not to treat with multiple weeks of antibiotics. A lot rides on accurate, timely diagnosis and treatment; untreated Lyme disease can cause severe neurologic and cardiac issues. Another example is COVID-19, where PCR testing has proven to be problematic due to shortages of reagents, long wait times for results, and complicated findings of both false positives and false negatives; all of these mitigate against implementation of the kind of disease management regimen we need to contain the virus, treat patients and monitor treatment progress.

Technology Overview:

Ciencia has developed a grating-coupled fluorescence plasmonics (GC-FP) instrument that enhances a fluorescent signal on a sensor chip, allowing very small quantities (microliters) of blood to produce a strong signal. The sensor uses established nanofabrication techniques which are comparable in cost and complexity to a CD or DVD. This system can detect one biomarker, or dozens of biomarkers, simultaneously; and it can do this accurately in under 30 minutes.

Researchers at SUNY Polytechnic Institute have created biochips for detection of Lyme disease and COVID-19 which, together with Ciencia’s GC-FP instrument, have increased diagnostic sensitivity beyond what is currently available. This combination of biochips and GC-FP reader is highly effective for detecting and differentiating multiple antibody isotypes (including IgG, IgM and IgA) and is amenable to direct antigen/infectious agent detection.

Further Details:
•    https://www.medrxiv.org/content/10.1101/2020.09.02.20187070v2
•    https://www.sciencedirect.com/science/article/pii/S0956566320306680
•    https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0228772


Advantages:

•    Rapid
•    High-content
•    Inexpensive
•    Sensitive
•    Flexible

Applications:

This system has been developed to test the presence of antibodies associated with Lyme and COVID-19 infection but can be used with any number of pathogens/target biomarkers. Other applications include monitoring the course of disease treatment and monitoring immunoglobulin mediated reactions such as transfusions or autoimmunity panels. Non-antibody-mediated applications are also supported on this system.

Intellectual Property Summary:

A provisional patent application has been filed to protect this technology.
•    SUNY Polytechnic Institute filed a provisional patent application for qualitative and quantitative analysis of biomarkers using plasmon enhanced fluorescence on July 3, 2020.
•    Ciencia currently holds US Patent 8,368,897 entitled [Dual-Mode Patent]
•    Ciencia currently holds US Patent 7,655,421 entitled [Cytometer on a chip patent]
•    Ciencia filed a provisional patent entitled, “Grating -Coupled Fluorescent Plasmonic Assay System” on November 13, 2020


Licensing Status:

This technology is available for licensing.

Licensing Potential:

This technology will be of value to any company or institution involved in detecting exposure to COVID-19 and other diseases. This includes:
•    Manufacturers of medical tests for viral diseases
•    Hospitals 
•    Clinical laboratories
•    Research institutions


Patent Information: