AnaZyme, LLC, a diagnostic assay company, in collaboration with researchers from the Bioengineering Department at UC San Diego, was created as a direct result from the research and development of InfammaGen—a new therapy to reduce morbidity and mortality related to multi-organ failure and death as a result of acute shock. AnaZyme—New Diagnostic Assays Early diagnosis is key to successfully treating acute shock. Currently, there are no diagnostic tests to diagnose shock before significant organ damage has occurred and clinical manifestations exist. Current techniques to detect inflammatory activity in shock are based on symptomatic measurements (organ and neuronal dysfunctions, perfusion failure, skin color changes) or biochemical analysis (e.g. cytokine levels in plasma). These are late stage detection systems, which are unable to assist in early intervention. Researchers have discovered several biomarkers which may diagnose the onset of shock and its progression during treatment. These biomarkers are measured from both exhaled breath and liquid blood samples. Three assays have been created from these biomarkers and confirmed in both animal and human samples. These assays can be run on current hospital testing devices or commercially available general purpose laboratory instruments. The three assays are: Exhaled breath-based assay to detect volatile compounds. Blood-based assay to detect specific enzymes. Blood-based assay to detect the absence of specific compounds. For the breath assay, volatile compounds have been identified in rats and initial human testing is underway at two academic medical centers. AnaZyme™ is a new breath or blood assay to help physicians diagnose the onset of acute shock and monitor InflammaGen therapy. It is anticipated that these assays will become the standard of care in cases involving shock and multi-organ dysfunction syndrome (MODS) as a point-of-care, hand-held breath device which will be able to identify these volatile compounds. The total available market surpasses $2 billion in the U.S. alone, and is based on an assay price of $25 per assay.
Capital: AnaZyme (diagnostic assay) is being developed jointly with InflammaGen Shok-Pak (therapy). Preclinical funding has been provided by NIH grants and translational funding by Leading BioSciences, Inc. (formerly Leading Ventures). Combined with InflammaGen, AnaZyme will raise $5 million to complete human trials and find a partner to commercialize and bring to market.
A Leading BioSciences, Inc. Company
3580 Carmel Mountain Road, San Diego, CA 92130
Tel: (858) 395-6099
John Rodenrys – CEO
Hank Loy – President
Greg Doyle – CFO
Funding by Leading BioSciences, Inc.
Geert Schmid-Schönbein, PhD
Jacobs School of Engineering