Northeast Ohio
Technology Sector: 

CelerDx is a diagnostic startup that is developing a rapid test platform to detect bacterial infection and antibiotic sensitivity.

When administering medical care for a patient with an infectious disease, the rapid and accurate establishment of a microbial cause is fundamental to quality care. Limited by a decades old laboratory process, many patients with suspected infections receive empiric antimicrobial therapy rather than appropriate therapy dictated by the rapid and accurate identification of the infectious agent.  Despite dramatic advances, today’s diagnostic technologies are not only time consuming but they also cannot distinguish between bacterial colonization and bacterial infection. Combined, these drawbacks result in prolonged hospital stays, increased resistance of microorganisms to antimicrobials, unnecessary deaths and massive additional costs to healthcare systems.

Bacteria display two life forms during growth and proliferation in the human body. In one form, the bacteria appear as single, independent, free floating cells (planktonic).  When bacteria are in this planktonic mode, the body can easily clear the infection.  The second form, however, is far more serious, and is what leads to the symptomology associated with infection.  When possible, bacteria will organize in sessile or anchored aggregates, attaching to tissues or indwelling medical devices (e.g. prosthetic joints, artificial heart valves, stents, etc.). This small, local community of bacteria is called a biofilm. Biofilms, when virulent, are notoriously impervious to antibiotics and can expand exponentially and spread to the blood or other body compartments producing the clinical signs of infection.

CelerDx has perfected a simple serological test to identify infection caused by pathogenic bacteria in a biofilm mode.  More than 60% - 80% of microbial infections in the body are caused by bacteria growing as a biofilm. This is a large and growing global public health issue. The CelerDx patented technology is an elegant solution that can help to address this problem.

CelerDx has utilized transcriptomics, proteomics, immunoproteomics and imaging analyses to identify very specific antigens that are expressed by pathogenic bacteria only when they are in a biofilm mode of growth. We’ve used the understanding of these highly specific antigens to develop a serological laboratory test that works by identifying the presence and quantity of the antibodies generated by the immune system, showing the body’s specific response against the offending bacteria now hunkering down in biofilm mode.  Our patented approach allows for quick and accurate identification of the pathogenic bacteria, but importantly also allows for detection of infection days or even weeks before symptoms arise, raising the potential of screening for infection in certain clinical situations, or among high risk populations. Our first product is for detection of Staphylococcus aureus “staph” and Methicillin-Resistant Staphylococcus aureus (MRSA).