A Fluorescent Plasmonic Biochip Assay for Multiplex Screening of Diagnostic Serum Antibody Targets in Human Lyme Disease and COVID-19

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:

- 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:

Through partnering with SUNY Polytechnic, Ciencia aims to explore two particularly commercially-viable applications for this technology: Lyme disease detection and COVID antibody characterization. The team is seeking development partnerships or licensing partners able to complete development and market this technology.

Licensing Potential:

Licensing, Commercial partner