Fast Detection of Hypervirulent Clostridium Difficile
Overview
When a patient presents with symptoms of Clostridium difficile (C. difficile), rapid determination of the toxicity of the strain is of paramount importance; if a hypervirulent strain is identified, it is important to begin appropriate antimicrobial therapy as quickly as possible. Our novel method, which uses a single reaction tube, radically improves the process of determining the toxicity of a C. difficile strain.
Market Opportunity
C. difficile is a common cause of antibiotic-associated diarrhea, accounting for 15%–25% of cases. A more virulent form that has been identified is characterized by severe disease and increased morbidity and mortality. Delays in proper identification of a C. difficile strain hinder timely initiation of treatment, as well as necessary infection-prevention steps in health care facilities, where C. difficile transmission poses significant health threats. Current methods of diagnosis are either highly sensitive and specific but require several days to complete, or are highly specific and rapid but lack sensitivity. Thus there is a critical need for a simple, rapid, and highly sensitive method of detecting and identifying hypervirulent C. difficile, particularly in health care settings.
Innovation and Meaningful Advantages
Our method rapidly and sensitively detects the presence of C. difficile through the use of multiplex PCR (a single polymerase chain reaction that amplifies several DNA sequences simultaneously). It can also be used to identify various mutations in the bacterial genome that correspond to clinically relevant markers of pathogenicity—specifically, the presence of an 18 bp deletion in the regulatory tcdC gene, which is associated with a hypervirulent strain of the bacteria, and the presence of a binary toxin gene that is also present in emerging strains of C. difficile. Our method can be used with biological samples consisting of stool, sputum, peripheral blood, plasma, serum, lymph nodes, respiratory tissue, or exudates.
Collaboration Opportunity
We are interested in exploring 1) research collaborations with leading medical diagnostics companies to develop this technology; and 2) licensing opportunities with medical diagnostics companies.
Principal Investigator
Anubhav Tripathi, PhD
Professor of Engineering
Director of Biomedical Engineering
Brown University
Brown Tech ID 1952J
anubhav_tripathi@brown.edu
https://vivo.brown.edu/display/atripath
IP Information
US9234248B2; patent issued, 2016-01-12.
Publication
Angione SL, Sarma AA, Novikov A, Seward L, Fieber JH, Mermel LA, Tripathi A. A novel subtyping assay for detection of Clostridium difficile virulence genes. J Mol diagon. 2014 Mar;16(2);244-52. PMC: 3937534.