BCR Biotech

BIOSENSING TECHNOLOGY

Schematic of Biosensor chip showing 10 fluorescent microwells.

F-spores ™ and LEXSAS™ at the BIOSENSOR core

BCR’s technology is based on an innovative engineering process that creates synthetic functionalities in living Bacillus spores. First-generation products are fluorogenic spores (F-spores™) performing as self-reporters of viability or as bacteria detectors.

Two initial commercial applications using F-spores™ are:

Sterility assurance
Bacteria detection in platelets intended for transfusion

Sterility Assurance

F-spores™ are ideal microorganisms for developing rapid (30-60 min) readout biological indicators (BIs) because of their self-reporting characteristics. Our BI will fulfill the needs of the sterilization industry because currently marketed BIs have protracted readouts extending to 2-7 days.

The potential advantage of our BI is expected to translate into a successful commercialization in the U.S. and international markets. Possible customers for the BI include the Healthcare industry, the Food and Beverage Industry and the Pharmaceutical Companies.

Detection of bacterially-contaminated platelet units

Contamination of blood products with bacteria is currently a significant public health problem and a leading cause of transfusion-related deaths. Platelets are particularly susceptible to contamination because they must be stored at room temperature.

BCR has developed a novel biosensor platform for detecting low levels of bacteria in less than 20 minutes and has applied the technology to detection of bacterially-contaminated platelets. The biosensor is based on the LEXSAS™ (Label-free Exponential Signal-Amplification System), a unique system using F-spores™ as nanodetectors emitting fluorescent light signals when encountering bacterial cells.

For scientific principles and detailed operation of the biosensor see Patents & Publications

Based on R&D at BCR laboratories, the commercial biosensor will have the following characteristics:
1.		Ability to detect a single bacterium.
2.		Ability to yield quantitative results in less than 20 minutes.
3.		Minimal sample preparation.
4.		No labeling reagents (such as fluorescent, radioisotopic or enzymatic reporter molecules) will be required.
5.		Linear detection response over a wide dynamic range of one to 50,000 bacteria per milliliter.
6.		Single use (disposable), low manufacturing cost.
7.		Applicability to automated high-throughput operations.
8.		Portability for point-of-care (POC) testing.


The BCR Biochip	Spores in the BCR Biochip

Infectious Diseases
(Background Information)

Infectious diseases are currently the leading cause of death in the world and the third leading cause in the United States. Rapid and sensitive detection of infectious disease is crucial because it minimizes death, illness, disability, and economic losses.

In a 1999 issue of Science, scientists of the National Center for Infectious Disease (NCID) discuss public health issues and predict that current factors contributing to infectious disease emergence will continue, if not intensify, in the 21st century. (Science 1999 May 21;284:1311-3 )

For a significant number of infectious diseases, early diagnosis is essential because any delay of treatment increases the risk of death from septicemia (invasion and persistence of pathogenic bacteria in the blood). In the United States alone, sepsis affects about 400,000 individuals every year and has a mortality rate of 30-50%. At present, early diagnosis of sepsis is difficult because traditional testing by blood culturing requires 16-48 hours for completion.