This proposed platform uniquely addresses several needs in the Lyme diagnostic field and generates a unique ‘fingerprint’ of reactivity for each patient specimen.
SEATTLE (PRWEB) November 15, 2022
InBios International Inc., a leading developer of diagnostics for infectious diseases, announced that the U.S. Department of Health and Human Services (HHS) and the Cohen Foundation have awarded the company $100,000 as a Phase 1 winner in the LymeX Diagnostics Prize competition.
InBios will use the funding to develop an automated, quantified, array-based serum test using machine learning to improve sensitivity in categorizing specimens. The company also will receive an invitation to participate in a second phase.
“This proposed platform uniquely addresses several needs in the Lyme diagnostic field and generates a unique ‘fingerprint’ of reactivity for each patient specimen,” said James Needham, PhD, Director of Product Development, Research and Development. “This array-based immunoassay simultaneously detects and quantifies IgM and IgG responses to a panel of target antigens and offers improved detection in the early acute stage. This lab-based, multiplexed ELISA can be completed in 90 minutes and incorporates machine learning algorithms to better categorize these patterns of reactivity into a clear diagnostic result.”
The current two-tier serological testing system relies on the presence of antibodies and can only be used accurately four to six weeks after infection. The LymeX Diagnostics Prize’s open innovation model accelerates discovery and development by providing funding and access to key resources and collaboration opportunities.
“We believe InBios brings together a unique set of strengths to successfully develop this test, including a robust protein engineering group, assay development and transfer teams, scaled manufacturing and an experienced regulatory team that has brought several products through the FDA 510(k) clearance process,” said Syamal Raychaudhuri, PhD, InBios Chief Scientific Officer. “Furthermore, we anticipate investigating point-of-care applications utilizing this technology during this phase. This funding provides an opportunity to expand the panel of tested Lyme specimens, improve protein production and purification, finalize protein microarray target selection and to further develop the required software to automatically analyze test results. We look forward to the further development of this novel platform with its clear applications to the Lyme diagnostic field.”
At the discretion of HHS and the Cohen Foundation, and subject to availability of future funding, at least one additional phase may follow Phase 2. Future phases are expected to focus on clinical and nonclinical validation of diagnostic tests that detect active infection by Lyme-disease-causing bacteria, as well as readiness for regulatory submission and market entry. Thanks to a $10 million pledge to the LymeX Diagnostics Prize from the Cohen Foundation, $9 million in additional LymeX prizes are projected to be available in proposed future phases.
About InBios: InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Located in Seattle, Washington, InBios offers superior quality products which are accurate, easy to use and cost effective. InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified. For more information, visit http://www.inbios.com.