Smiths Detection wins $3.2m in grants to develop tests for sepsis pathogens and flu
29 October 2009
Smiths Detection has won two grants from the US National Institutes of Health for the development of tests using its Clinical Bio-Seeq instrument.
In the first grant, Smiths Detection has been awarded a $2.2m, two-year grant from the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health (NIH), to develop a point-of-care test for multiple types of influenza.
Global concern over the potentially devastating effects of a flu pandemic has grown due initially to an outbreak of H5N1 avian flu that crossed the species barrier to humans causing several deaths. More recently the H1N1 Swine Flu pandemic has infected more than 200,000 people of whom over 2,000 have died, according to a recent World Health Organization update.
These are just two forms of a highly diverse infection which is also present as ‘normal’ seasonal flu. While most currently available tests, particularly those that are suitable for use outside the laboratory, focus on an individual flu variant such as H1N1 or H5N1, Smiths Detection will develop a single rapid test to detect multiple flu variants.
This will be achieved by using the company's LATE PCR nucleic acid amplification and detection technology to detect and analyze multiple targets simultaneously. This technology was licensed from Brandeis University which will support the NIH project.
The test developed under this programme will be designed to diagnose disease in humans and will be suitable for use in a conventional laboratory setting or in a Point of Care setting running on the Company’s own clinical Bio-Seeq instrument.
A similar test, developed by Smiths Detection outside the NIH grant programme, will also be made available for diagnosing influenza infections in animals, including potential pandemic strains. The animal test will run on both desk top and field portable versions of the Bio-Seeq. Development of the field portable version is complete and the desk top clinical diagnostic version will shortly enter clinical trials.
When using Bio-Seeq, the sample is introduced into a disposable cartridge which is then placed on the instrument. No manual sample preparation steps are needed and the cartridge can process a variety of solid and liquid samples.
The second award is a $1m, two-year grant from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) to develop a rapid test for eight micro-organisms that commonly cause burn/wound infections leading to septicemia (blood-poisoning).
The test will run on Smiths Detection’s Clinical Bio-Seeq System, designed to be used at Point of Care in Critical Care settings.
Over 750,000 Americans develop sepsis each year. Globally, sepsis affects millions of people and is the leading cause of death in non-coronary Intensive Care Units (ICU). Patients with more than 20% burn coverage, run a 97% risk of developing a wound infection, and the longer it takes to identify the cause, the higher the risk of full sepsis.
Traditional pathogen detection methods can take up to 72 hours and even rapid molecular tests, when performed in a central laboratory, can take up to a day, depending on sample transport and processing times. The assay being developed under this grant, in conjunction with Bio-Seeq, is designed to provide test results in under two hours. With quicker access to information, physicians should be able to prescribe a more rapid and specific course of treatment, thereby improving patient outcomes.
Under this grant, Smiths Detection will expand its collaboration with the University of California, Davis — Lawrence Livermore National Laboratory (LLNL) Point-of-Care (POC) Technologies Center, which focuses on pathogen detection for critical, emergency, and disaster care. The Center is one of four in the NIBIB POC Technologies Research Network.
Validation of the assay, as well as evaluation of the performance of Bio-Seeq in an ICU setting, will be conducted at the UC Davis Medical Center. Dr. Gerald J. Kost, Director of the UCD-LLNL POC Technology Center and Co-investigator on this grant, said: “We know from formal needs assessment surveys that physicians want highly sensitive and fast detection of bloodstream and wound pathogens in critical care settings, so we believe this collaboration will provide invaluable new diagnostic information for bedside decision making in the U.S. as well as in low-resource countries.”
Development of this highly multiplexed test will be achieved by using Smiths Detection’s LATE PCR nucleic acid amplification and detection technology. This technology was licensed from Brandeis University, which will also support the project. The test will be suitable for use in a conventional laboratory setting or in a Point of Care setting running on the Company’s Clinical Bio-Seeq instrument. When using Bio-Seeq, the sample is introduced into a disposable cartridge which is then placed on the instrument. The system should require no specialised molecular biology training.