GlycoTyper: Proprietary Liquid Biopsy Assay Technology

N-Glycan profiling to provide new or substantial improvements in diagnostic, prognostic or therapeutic prediction assays

Liquid biopsies - unbiased to disease type

  • Non-Invasive - serum glyco-assays, untargeted and targeted

  • Resulting biosignature of captured proteins or total serum is the intellectual property

 

Methodology

 

Applying this technology to disease states: Liver Disease

Liver disease is a worldwide threat. There are currently immense and growing populations with viral and non-viral hepatitis—driving progressive fibrosis, liver cancer risk and the need for HCC surveillance. Currently, there are more than 1 billion people with some form of liver disease (viral, alcohol, NASH), resulting in over 2 million deaths per year from end stage liver disease, such as cirrhosis and hepatocellular carcinoma (HCC). In the USA there are an estimated 2.2 million people with chronic HBV (hepatitis B virus) infection, 3.2 million people with chronic HCV (hepatitis C virus) infection, an estimated 100 million people with fatty liver disease, and 3.2 million people with liver cirrhosis (driven by HCV and other factors). Historically, in individuals with HBV or HCV, advanced fibrosis and cirrhosis are considered justifications to begin antiviral therapy. More importantly, the determination of hepatic fibrosis is critical to stage the severity of liver disease and has been associated with prognosis. Therefore, it is extremely important to determine the presence of significant fibrosis and cirrhosis. Although liver biopsy has historically been the gold standard for assessment of fibrosis, noninvasive assessment of fibrosis is less intrusive and will allow for routine clinical monitoring.

 

GlycoFibroTYperᵀᴹ

Glycan profiling to monitor for progression of fibrosis to hepatocellular carcinoma

Easy

Based on convenient immunoassay methodology and utilizes mature antibody slide array technology

Faster

Exploits recombinant enzyme engineered for imaging methods, removing multiple purification steps

Effective

Standard of care for monitoring liver disease is ultrasound, biopsy, and transient elastography

Performance exceeds all current noninvasive tests

No Fibrosis vs. early/moderate fibrosis

Sensitivity: 93% Specificity: 89%

Early/moderate fibrosis vs. significant fibrosis/cirrhosis

Sensitivity: 82% Specificity: 88%

No fibrosis vs. significant fibrosis/cirrhosis

Sensitivity: 93% Specificity: 98%

 

In Phase 1 analysis, the patented GlycoFibroTyperᵀᴹ had 91% accuracy in detection of fibrosis in people without liver disease, 94% accuracy in the detection of cirrhosis in people with fibrosis and 86% accuracy in the detection of significant fibrosis (distinct from cirrhosis) in those with limited fibrosis.

Full publication: Scott, D. et. al. Frontiers in Immunology. 2022