3i Diagnostics announced that its new technology, called BiospectrixTM, for detecting and identifying bacteria directly from whole blood in less than an hour was granted Breakthrough Device designation by the US FDA.
GERMANTOWN, Md., March 15, 2018 /PRNewswire/ -- 3i Diagnostics announced today that its new technology, called BiospectrixTM, for detecting and identifying bacteria directly from whole blood in less than an hour was granted Breakthrough Device designation by the US FDA. The FDA’s Breakthrough Device Designation is intended to expedite the development and review of a diagnostic/device that demonstrates the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions thereby helping patients gain timely access to these medical devices.
Biospectrix does not require culturing and identifies a broad range of bacteria in < 1 hour directly from the patient sample as opposed to the 2-6 days currently needed for culture. Such a system can help initiate treatment using the appropriate antibiotic rapidly, and potentially reduce bacteria-related mortality, complications, and treatment costs. “We view this diagnostic as becoming a vital part of a toolkit that can be used globally to aid physicians in making treatment-related decisions i.e. if an antibiotic is necessary and, if yes, the appropriate antibiotic to use.” said Rajesh Krishnamurthy, CTO of 3i Diagnostics, Inc.
“We’re pleased to have been granted Breakthrough Device Designation for Biospectrix and look forward to working closely with the FDA to bring this diagnostic to the market as quickly as possible to address the huge unmet need for rapid broad-range bacterial identification without culturing” said James Janicki, CEO of 3i Diagnostics, Inc. “We see Biospectrix as being a key component of the global strategy to combat the antimicrobial crisis”
ABOUT 3i Diagnostics
3i Diagnostics (3iDx) is developing precision diagnostics for patients with infectious diseases. 3iDx has multiple applications in development that may enable breakthroughs in providing rapid, efficient, and effective care. The ability to confirm if the infection is of bacterial origin and, if yes, its identity is paradigm-changing for treatment of patients. We believe that rapid precision-diagnostics of infectious agents have the highest probability of delivering best-in-class disease control and safety while lowering the cost of healthcare and helping to combat the spread of antimicrobial resistance. Our management team seeks out experienced industry partners, world-class scientific advisors and innovative clinical-regulatory approaches to deliver these new diagnostic modalities for use in healthcare settings as quickly and efficiently as possible. For more information, please visit the company’s website at www.3idx.com.
