NIBIB awards $1M grant to develop a rapid test for sepsis-related pathogens

Smiths Detection today announces the award of 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.

Bill Mawer, head of Smiths Detection’s Diagnostics business, said: “This grant gives us the opportunity to start working in critical care, an area where the combination of our sophisticated assay technology combined with an easy to use, rapid platform seem likely to offer great benefit.”

The NIBIB is part of the US National Institutes of Health (NIH) and this award is the second NIH grant Smiths Detection has received in the last two months. Last month, Smiths Detection won a $2.2m grant from its National Institute for Allergy and Infectious Diseases (NIAID) to develop a highly multiplexed LATE-PCR assay for pandemic flu, which will also be run on the Clinical Bio-Seeq System.