SEATTLE, Dec. 3, 2024
InBios International Inc., a leading developer of diagnostics for infectious diseases, announced that it received a project award valued at $16,511,354 to optimize, complete performance validation, and file for FDA clearance(s) for the company's rapid test for melioidosis. Funding will accelerate development and regulatory approval of innovative diagnostic tools to safeguard public health.
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SEATTLE, Dec. 3, 2024 /PRNewswire-PRWeb/ -- InBios International Inc., a leading developer of diagnostics for infectious diseases, announced that it received a project award valued at $16,511,354 to optimize, complete performance validation, and file for FDA clearance(s) for the company's rapid test for melioidosis. This potentially deadly disease is caused by the bacterium Burkholderia pseudomallei (Bp), which can be found in nature or used as a biological weapon in an intentional attack.
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The contract was awarded under the Rapid Response Partnership Vehicle (RRPV), a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). The project funding is part of BARDA's Diagnostics Rapid Response Initiative (DxR2) which aims to close readiness gaps in biothreat test development and preparedness.
InBios will use the funding to build on its existing Active Melioidosis Detect™ Plus (AMD Plus) device design. The aim is to finalize the AMD Plus testing workflow and algorithm and obtain FDA clearance for the rapid test for identifying capsular polysaccharide (CPS) in patients with Bp infection in culture. Later, FDA clearance will be sought to expand the indication for testing of multiple direct specimens such as hemoculture, urine, pus, and respiratory samples.
CPS has been shown to shed into patient samples, making it a leading diagnostic antigen for the detection of Bp infection. In collaboration with Dr. David AuCoin's laboratory, University of Reno (UNR), a monoclonal antibody (mAb) specific to the CPS was developed and used to identify CPS in serum and urine samples from melioidosis patients by antigen-capture immunoassay. InBios constructed a rapid test, AMD Plus, using this mAb to detect CPS in patient samples in 20 minutes. Collaborators in Thailand, Cambodia, Laos and Australia have evaluated the AMD Plus using patient samples. Preliminary results have been very encouraging in various patient samples. Dr. David Aucoin will continue developing this test with InBios as Co-PI on the project.
"Bp has received much-needed attention due to the CDC's classification as a Category B select agent and its ability to cause significant morbidity and mortality in endemic regions," said Dr. Syamal Raychaudhuri, PhD, InBios' Chief Scientific Officer. "An FDA-approved test for the diagnosis of melioidosis does not currently exist. We will fill this gap by optimizing the Active Melioidosis Detect™ Plus (AMD Plus) Rapid Test and pursuing regulatory approval first for use with culture, and separately for use with direct specimens in near patient settings. This test fits well into our portfolio of diagnostics of global health importance."
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005.
About InBios: Since 1996, InBios has been a leader in the development of diagnostic tests for emerging infectious diseases and biothreats. Products are designed for superior performance, efficiency and value. These include several FDA market authorized and CE marked assays for arboviruses, parasitic infections, biothreats, and more. InBios continues to anticipate and serve the growing global public health demand. Products in the pipeline include next generation platforms for tick-borne and respiratory diseases. For more information, visit www.inbios.com.
Learn more:https://www.cdc.gov/melioidosis/about/index.htmlhttps://www.cdc.gov/melioidosis/bioterrorism/index.html
Media Contact
Wendy Bagnato, InBios International Inc., 1 206-326-5409, [email protected], www.inbios.com
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SOURCE InBios International Inc.
