Press Release 1.31.2020
BCR Diagnostics Unveils FiBIR
Simple Low-cost Technology for Fluorescence Amplification
Chandler, Arizona ― Today BCR Diagnostics, Inc. announced the discovery of “Fiber-based Internal Reflection” (FiBIR), an unprecedented optical phenomenon poised to revolutionize the growing fluorescence-based assay industry.
“Because of its simplicity and low cost, we expect FiBIR to lead the development of next generation fluorometers,” said Dr. Boris Rotman, BCR’s Vice President and Chief Scientific Officer. “BCR plans to offer royalty-based, non-exclusive licenses for both R&D and marketing.”
“In our prototype fluorometer,” Rotman adds, “FiBIR is effected in a 6-mm chip designed to hold 12 µl samples. We envision other physical configurations, such as automated fluorometers using FiBIR cartridges for nanoliter samples.
The prototype FiBIR fluorometer performs at a sensitivity 20-times higher than the best instruments in the same price range. BCR estimates FiBIR fluorometers will retail under $ 600.
Founded in 1994, BCR Diagnostics, Inc. (www.bcr-diagnostics.com) has been pioneering development of transformative technologies that advance fluorescence-based detection platforms. The R&D leading to the FiBIR fluorometer was partially supported by an SBIR Phase I award from the National Institutes of Health.
BCR Diagnostics, Inc.
Info (–) bcr-diagnostics.com
Press Release 11.8.2010
BCR Diagnostics awarded $204,630 grant under Qualifying Therapeutic Discovery Project (QTDP) program
Chandler, Arizona, – BCR Diagnostics, Inc., a biotechnology company specialized in developing a new line of cell-based biosensors, announced today it has received a cash grant from the federal government under the QTDP for developing a rapid biological indicator (rBI) for steam sterility testing. The QTDP was created as part of the Patient Protection and Affordable Care Act of 2010 to provide support for innovative projects that are determined by the U.S. Department of Health and Human Services to advance U.S. competitiveness in the fields of life, biological, and medical sciences.
“The grant will be used to expand our platform of rapid biological indicators for steam sterility testing to other sterilization processes, such as Ethylene Oxide and Hydrogen Peroxide,” said Boris Rotman, CSO at BCR. “There is an urgent need in the healthcare industry for more rapid biological indicators that are as reliable as traditional spore cultures requiring 24-48 hour for completion.”
FDA Clears a New Type of Biological Indicator for Monitoring Effectiveness of Sterilization at Healthcare Facilities
Taking sterility testing to higher levels, BCR Corp. announced FDA’s clearance of BCR-30-min BI, a remarkably simple and rapid Biological Indicator (BI) containing spores of heat-resistant bacteria.
The BCR-30-min BI is the first BI that perfectly matches CDC’s definition of an ideal monitoring system:
CDC, Dec. 2009: “An ideal biological monitor of the sterilization process should be easy to use, be inexpensive, not be subject to exogenous contamination, provide positive results as soon as possible after the cycle so that corrective action may be accomplished, and provide positive results only when the sterilization parameters (e.g., steam-time and temperature, and/or saturated steam; ETO-time, temperature, relative humidity and/or ETO concentration) are inadequate to kill microbial contaminates.”
Driven by public needs for safer and faster sterilizing procedures, the BI has evolved considerably over the past decades. Despite the technological advances, present-day self-contained biological indicators (SCBIs) still have limitations: (1) relatively high cost compared to the traditional spore strips; (2) occurrence of “false negatives” caused by air trapped in the indicator; and (3) exclusion of extensive sterilization that can damage either the growth medium or the fluorogenic substrate. False negatives are particularly significant because they may conceal contaminated surgical supplies in use.
The unprecedented features of the BCR-30-min BI derive from a novel technology (patent pending) centered on phenotypically engineered spores (termed F-spores) that function as self-reporters of germination. F-spores have the unique property of being fluorogenic, i.e., they are non-fluorescent when dormant but produce intense fluorescence a few minutes after the onset of germination (PLoS ONE 5, e9283, 2010). Measuring spore germination (instead of conventional spore outgrowth) enables extremely short readouts without sacrificing sterility assurance.
For testing the BCR-30-min BI after exposure to a sterilization cycle, the spore strip is introduced in the RBIP-ST30, the readout accessory, for automatic processing. NO aseptic technique is required. In the RBIP-ST30, viable spore survivors are converted into F-spores producing intense fluorescence. Dead spores, however, do NOT produce fluorescence. The RBIP-ST30 computes the spore’s fluorescence, calculates the sterility assurance level (SAL), and reports whether the sterility cycle is in compliance.
The figures below show the BCR-30-min BI together with a diagram of a self-contained BI (SCBI), currently the most used BI.
According to Dr. Boris Rotman, BCR’s Vice President and Chief Scientific Officer, “The low cost and the 30-minute readout of the new biological indicator permit every load monitoring, the best practice for improving patient safety and preventing costly recalls due to sterilization malfunction. Also, an attribute unique to the new indicator is that it contains only spores, which allows for extended sterilization, a significant advantage not found in existing self-contained indicators.”
Founded in 1994, BCR Diagnostics, Inc. (www.bcr-diagnostics.com) has pioneered development of transformative technologies that advance fluorescence-based detection platforms. The R&D leading to the BCR-30-min BI was partially supported by SBIR awards Phase I and II from the National Institute of Allergy and Infectious Diseases.
BCR Diagnostics, Inc. ― http://www.bcr-diagnostics.com/