A new rapid test to diagnose melioidosis, a difficult infection to treat - and classified as a biothreat by the Centers for Disease Control and Prevention - is being optimized and tested by University of Nevada School of Medicine researcher David AuCoin.
A $600,000 National Institute of Allergy and Infectious Diseases grant through the Small Business Technology Transfer (STTR) program recognizes the potential of AuCoin's work and supports making the new rapid test for point-of-care diagnosis of melioidosis available to countries where the disease is endemic, and expanding.
Melioidosis, also called Whitmore's disease, is predominately an infectious disease of tropical climates, especially in Southeast Asia and northern Australia where it is widespread. The bacteria causing melioidosis are found in contaminated water and soil. It is spread to humans and animals through direct contact with the contaminated source and has a high mortality rate.
"We have a prototype of the product in Thailand and Australia now, regions that are hardest hit, to evaluate it's effectiveness in endemic settings," AuCoin said. "There is no validated diagnostic product for melioidosis, patient samples must now be cultured, which takes three to seven days in order to diagnose the disease. Unfortunately, melioidosis can kill you well before the diagnosis is confirmed."
With the two-year Phase I STTR grant, AuCoin's laboratory is collaborating with InBios International of Seattle, Wash. on development of the Active Melioidosis Detect™ (AMD) test. They both are working closely with experts in the endemic areas of Thailand and Australia who are currently evaluating the test with different sample patient types.
"Results so far are very encouraging," AuCoin said. "We produced a monoclonal antibody to identify the Burkholderia pseudomallei bacterium, which causes melioidosis, and then introduced it into a prototype lateral flow immunoassay diagnostic, which is a dipstick test that can accept many patient sample types."
AuCoin produced and has been working with the monoclonal antibody used in the test since 2009. The work is also funded by the Pacific Southwest Regional Center for Excellence in Biodefense and Emerging Infections.
The STTR is a Phase I grant. The team is working to secure Phase II funding following the two years of Phase I work, which will allow another three years of product development to generate the necessary preclinical studies to submit an application to the FDA for approval to distribute the assay.
In addition to diagnosing a melioidosis infection, the lab has shown that it may be possible to treat patients with antibodies that bind to B. pseudomallei to prevent severe disease.
B. pseudomallei has been classified as a biothreat by the CDC due to its high mortality rate, low infectious dose and ability to be aerosolized. Melioidosis is difficult to treat and diagnose because B. pseudomallei is resistant to common antibiotics and symptoms are non-specific. Mortality rates reach 45 percent and 20 percent in Thailand and Australia respectively, even with antibiotic treatment.
AuCoin is a principal investigator within the Diagnostics Discovery Laboratory, which is a research group within the University of Nevada School of Medicine's Department of Microbiology and Immunology. The lateral flow immunoassay (LFI) he is developing is a similar process as another developed in the lab on the Reno campus by professor of microbiology and immunology Tom Kozel.
Kozel's LFI is a new point-of-care test to detect a cryptococcal antigen, and diagnose cryptococcal meningitis, a leading cause of death among AIDS patients in developing countries. The new rapid diagnostic has the potential to save hundreds of thousands of lives a year. Kozel and AuCoin are also collaborating on a diagnostic product for the early detection of inhalation anthrax and invasive aspergillosis.
"The work by Dr. AuCoin and his research group is just one more outstanding example of the ways that basic science research can lead to important clinical discoveries and improve health and health care," Thomas Schwenk, dean of the University of Nevada School of Medicine said. "In this case, the work is likely to lead to a new technology from here in Nevada that can have a profound positive impact on the outcome of a deadly disease on a global scale."