SBIR-STTR Award

BCR Diagnostics, Inc. (BCR) proposes to demonstrate the feasibility of adapting its LEXSAS (Label-free Exponential Signal-Amplification System) technology for real-time bacteriologic analysis of blood products intended for transfusion. The LEXSAS technology is unique in that it uses spores as ultrasensitive nanodevices capable of emitting fluorescent light signals when encountering single bacterial cells. This extraordinary ability is due to integrated spore mechanisms for sensing/transducing/amplifying discrete biomolecular signals in the milieu. Based on theoretical considerations and preliminary studies, BCR expects that the biosensor will have the following specifications: ability to detect a single bacterium; ability to yield quantitative results in less than 60 minutes; minimal sample preparation; no labeling reagents (such as fluorescent, radioisotopic or enzymatic reporter molecules) are required; linear detection response over a wide dynamic range of one to 10E6 bacteria per ml; single use (disposable), low manufacturing cost; and applicability to automated high-throughput operations. A real-time bacteriological biosensor should have a major impact not only in making transfusions safer for patients, but also in the financial aspects of blood banking. PROPOSED COMMERCIAL APPLICATION: BCR's real-time bacteriologic biosaensor would have a critical impact in public health and other major industries now relying on culture-based testing that usually requires 16-48 hours for completion. Potential commercial applications of the technology include: (1) clinical diagnostics; (2) bioterrorism defense; (3) screening food and beverages; (4) environmental monitoring (air and water); (5) sterility testing; and (6) screening blood products intended for transfusion.

Thesaurus Terms:
bacterial cytopathogenic effect, biosensor, blood bank /supply contamination, communicable disease control, communicable disease diagnosis, diagnosis design /evaluation aminopeptidase, bacteria infection mechanism, biomedical automation, consumable /disposable biomedical equipment, high throughput technology, time resolved data clinical research, human tissue

Bacterial contamination of blood products is currently a major problem in transfusion medicine and a leading cause of transfusion-related deaths. Platelets are particularly susceptible to contamination because they are stored at room temperature. BCR Diagnostics, Inc. (BCR) has developed a novel biosensor platform for detecting low levels of bacteria in real time (i.e., about 2 minutes). During Phase I, BCR has demonstrated the feasibility of adapting its technology to developing a low-cost biosensor for detecting bacteria in platelet concentrates shortly before transfusions. BCR's biosensor is based on the LEXSAS (Label-free Exponential Signal-Amplification System), a unique methodology using spores as ultrasensitive nanodetectors capable of emitting fluorescent light signals when encountering single bacterial cells. For Phase II, BCR proposes: 1. To construct a marketable biosensor prototype that will extend the system's sensitivity to single bacterial cells. 2. To use the prototype for a study designed to obtain experimental data that will meet the Food and Drug Administration (FDA) requirements for premarket approval of the biosensor. The study will consist of three major tasks: 1. To test, optimize, and standardize the biosensor prototype in terms of sensitivity, completion time, analysis reproducibility, and dynamic range. 2. To use the prototype for experiments designed to obtain a "Data Package" to be submitted to the FDA. This task includes experiments that will show the accuracy (sensitivity and specificity) of the biosensor for identifying platelet concentrates spiked with a panel of about 13 different bacterial strains from a list provided by the FDA. 3. To do a double-blind study to validate the commercial usefulness of the biosensor. Other potential applications of the bacteriologic biosensor include: diagnostics, environmental surveillance, food and beverage monitoring, and sterility testing.

Thesaurus Terms:
bacteria, bacterial cytopathogenic effect, biosensor, blood bank /supply contamination, communicable disease control, communicable disease diagnosis, diagnosis design /evaluation aminopeptidase, bacteria infection mechanism, biomedical automation, consumable /disposable biomedical equipment, high throughput technology, platelet, time resolved data clinical research, human tissue