HISTORY
The founders of TECHLAB®, Inc. began their work on Clostridium difficile and its toxins back in the late 1970s and early 1980s. This work was done at the Anaerobe Laboratory at Virginia Tech. The VPI Anaerobe Laboratory was unique in itself. It was one of only three institutions in the world dedicated to the study of anaerobic organisms. Research on C. difficile, headed by Dr. Tracy Wilkins, soon branched out to include work not only on toxins A and B of C. difficile, but also better ways to diagnose and treat C. difficile infection, including the development of high-titered antiserum for use as a diagnostic reagent. Interest in this reagent grew quickly as the healthcare profession began to realize the importance of C. difficile as a hospital pathogen. Eventually Virginia Tech asked that the sales of antiserum be taken outside to a private company because the University is a nonprofit organization. This was done in 1989, and TECHLAB® was incorporated. Our company is focused on enteric disease and microbiology of the intestinal tract.
Clostridium difficile
C. difficile has been recognized as a healthcare problem in the U.S. for several decades, but over the past several years, it has become an even greater threat and burden. This opportunistic pathogen, which costs our healthcare system more than a billion dollars annually, is becoming more resistant to antibiotics and possibly more pathogenic by acquiring additional virulence traits. In addition to its prevalence in hospitals, C. difficile disease is now being seen in nursing homes and outpatient clinics. A major part of our efforts are directed at the development of in vitro diagnostic tests for C. difficile. These tests, which range from tissue culture assay reagents to ELISAs and most recently, rapid membrane tests, detect C. difficile antigen (glutamate dehydrogenase) and toxins A and B directly in fecal specimens. To ensure that performance characteristics of these tests are met, we collaborate extensively with clinical directors at large university-affiliated hospitals, community hospitals, and healthcare associations. In addition to these collaborations, we perform in-house research to develop new and improved C. difficile diagnostics and monitors clinical isolates for increased virulence. Included are test panels consisting of assays for biological activity, antibody-based tests, and PCR for the detection of the toxin genes and other pathogenic traits such as increased resistance to antibiotics and newly acquired binary toxin. In addition to our diagnostic research, we have received NIH funding to develop probiotics as an alternative approach for the treatment and prevention of C. difficile disease.
Giardia, Cryptosporidium, and Entamoeba histolytica
We are actively involved in multiple research collaborations examining human susceptibility to the protozoan parasites Giardia spp., Cryptosporidium spp., and Entamoeba histolytica. Giardia is the most commonly identified protozoan parasite in the U.S. Cryptosporidium has made the news because of its association with outbreaks. Although not commonly seen in the U.S., E. histolytica is a common cause of diarrhea/dysentery in developing countries. Our company specializes in the development of diagnostic assays that target fecal parasite antigen detection for each of these pathogens. In addition, as part of our efforts to improve diagnostics for E. histolytica, our research involves the development of serum anti-parasite antibody detection. Our parasitology collaborations include grant projects funded through NIH, The Bill and Melinda Gates Foundation, and NIAID’s Phase I and Phase II Small Business Innovation Programs. We work closely with a worldwide team of top parasitology researchers assembled by Dr. William A. Petri, Jr. at the University of Virginia. Dr. Petri’s studies of parasitic disease etiology help drive the development and clinical efficacy of the diagnostic assays produced by TECHLAB®, Inc. The collaboration with Dr. Petri has produced the only diagnostic assay specific for the pathogenic species of Entamoeba, E. histolytica. Other assays on the market cross-react with non-pathogenic species of Entamoeba such as E. dispar. Additionally, we are involved in a multi-year project with Dr. Petri to produce a recombinant vaccine against E. histolytica.
Biomarkers for Intestinal Inflammation
During the inflammatory process, neutrophils become activated and infiltrate the intestinal lumen. The infiltrating neutrophils cause an elevation in fecal lactoferrin that can be measured by immunoassay. Thus, fecal lactoferrin serves as an accurate biomarker for intestinal inflammation. We have been involved for more than a decade in the characterization and validation of lactoferrin as a biomarker for acute and chronic intestinal inflammation. Our early studies were in collaboration with Dr. Richard Guerrant at the University of Virginia, who showed that fecal lactoferrin was an accurate marker for leukocytes in fecal specimens. More recently, we have expanded this work to demonstrate the value of fecal lactoferrin as a marker to distinguish inflammatory bowel disease, which can become life-threatening, from irritable bowel syndrome, which is less serious and which does not require drug intervention. These studies have generated numerous journal publications from top medical centers such as the University of Virginia, Children’s Hospital of Harvard University, Riley’s Hospital for Children, The Mayo Clinic, Cleveland Clinic and the University of Chicago. Our clinical research collaborations have led to the FDA clearance of qualitative and quantitative lactoferrin diagnostic tests. Our continued efforts to evaluate lactoferrin for monitoring disease activity and effectiveness of medical therapy potentially will lead to advances in diagnostics for chronic intestinal illnesses.