Licensing effort for Shiga toxin diagnostic tech awarded
The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) and the Uniformed Services University of the Health Sciences (USU) received the 2015 Federal Laboratory Consortium Award for Excellence in Technology Transfer.
It is for work on Shiga toxin-producing E. coli by Alison O'Brien, professor and chair of USU's Microbiology and Immunology Department, and her colleagues.
Two assay formats
USU researchers developed two assay formats that can detect Shiga toxin produced by multiple strains of E. coli.
The first is a detection technology used in food and clinical samples, while the second is a diagnostic assay that uses monoclonal antibodies, developed at USU, to detect Shiga toxins.
As a result, rapid tests are now able to detect and differentiate the toxins in about 30 minutes, allowing timely diagnosis of Shiga toxin-producing E. coli and appropriate treatment plans.
The Shiga toxin diagnostic technology was transferred under a license to Alere, a company with a focus on rapid diagnostic products and licensed as Shiga Toxin Chek and Shiga Toxin Quik Chek.
To further the development of the Shiga toxin technology into a commercial product there was a cooperative research and development agreement with Alere and TechLab, a sublicensee of Alere.
Alere said the FDA had cleared the test for the US market in 2012.
The Federal Laboratory Consortium will present the award in April.
Shiga toxin challenge
Two strains of the Shiga toxin are responsible for 265,000 intestinal infections each year in the US.
Infections can result in acute diarrhea, hemorrhagic colitis, and in 5% to 10% of cases, life-threatening hemolytic uremic syndrome.
Dr O'Brien and her colleagues addressed the challenge that previous diagnoses were hampered by slowness of culturing methods, which could take at least 24 hours to complete, and the difficulty of diagnosing certain strains by culturing.
Existing detection kits did not provide the sensitivity necessary for rapid same-day testing of samples or diagnosis at physicians' offices and clinics.
“The work by Dr O'Brien and others stands as an important achievement that illustrates the frequently untold story about military medicine's commitment to sharing its advances with the civilian world," said John W. Lowe, HJF president and CEO.
