CLEU DIAGNOSTICS, LLC awarded Phase I SBIR Grant from NIH

InteliSpark Client, CLEU Diagnostics LLC, has been awarded a phase I small business innovative research (SBIR) grant from the NIH department, National Institute of Allergy and Infectious Diseases. Their project, “Rapid Electrochemical Biosensor for Point-of-Care Diagnosis of Joint Infection”, will focus on an innovative technology approach for improving diagnosis of infection after total joint replacement (TJR). 


Total joint replacement has posed consequences for patients such as infection, along with a high 5-year mortality rate and (>25%), and an immense societal burden. The single most common reason for patients to present to the emergency department after TJR, is due to concern for infection. A delayed diagnosis can prolong morbidity, reduce the chances for successful infection eradication, and sometimes even lead to sepsis. Diagnostic errors and unnecessary overtreatment pose the possibility of even more damage, given the multiple aggressive surgical interventions and long-term, potentially toxic antibiotic treatment required to manage an infected joint replacement, much akin to cancer therapy. Additionally, making a diagnosis of infection remains a challenge for physicians. Clinical suspicion alone is ineffective for identifying the presence of infection, as outward clinical signs, such as erythema or swelling, are non-specific and cannot be differentiated from other forms of inflammation. Currently, there is no practical point-of-care (POC) test available that can allow physicians to quickly and reliably diagnose a joint infection in order to facilitate prompt clinical decisions in real-time. 


CLEU Diagnostics' goal is to develop the first POC test for infection diagnosis based on a novel electrochemical assay that measures the activity of leukocyte esterases (LE) in joint fluid. LE are antimicrobial proteases released by activated neutrophils recruited to sites of infection. The cellular expression of such antimicrobial peptides rises dramatically in response to acute infection; thus, these enzymes serve as ideal biomarkers for joint infection, with nearly optimal diagnostic accuracy. Their approach is driven by their proprietary biosensor technology, which allows for rapid, quantitative detection of LE using low-cost, disposable screen-printed electrodes, similar to glucose meter test strips. CLEU Diagnostics’ novel biosensor will allow physicians in the office or ED to evaluate fluid aspirated from a persistently painful joint replacement with a high diagnostic accuracy in just minutes. Not only will this facilitate prompt intervention for those with an infection, but more commonly it will allow physicians to definitively rule out infection and prevent undue psychological distress, and even hospital observation, for those without a joint infection.