The Centers for Disease Control and Prevention (CDC) has announced intentions to issue a sole source contract to BBI Solutions to support optimization of an anthrax toxin diagnostic.
The purpose of this procurement is to advance a lateral flow device diagnostic for anthrax toxin lethal factor from early prototype stage to a device ready for validation. BBI Solutions will optimize the diagnostic to enhance sensitivity, finalize design, define performance characteristics, and prepare for clinical validation.
“Our laboratory scientists provide unique subject matter expertise in B. anthracis microbiology, pathogenicity, and in the prevention, diagnosis and treatment of anthrax,” states the contract announcement. “This procurement will advance our current device from early prototype to a device ready for validation.”
This contract will provide the necessary enhancements to advance the device from prototype to validation-ready device, including activities to:
- Maximize sensitivity of the devices
- Identify quality control panel for evaluation of devices
- Establish final cartridge design
- Establish data collection and interpretation methods
- Obtain performance data on assay
Devices from this project are expected to result in a late stage product ready for clinical validation and testing. Data generated will be available for inclusion in an FDA 510(k) submission package.