Precision diagnostics company 3i Diagnostics reported on Thursday the receipt of the US FDA's Breakthrough Device designation for the new technology, called Biospectrix, for detecting and identifying bacteria directly from whole blood in less than an hour.
According to the company, Biospectrix does not require culturing and identifies a broad range of bacteria in less than one hour directly from the patient sample as opposed to the two to six days currently needed for culture.
In conjunction, Biospectrix can help initiate treatment using the appropriate antibiotic rapidly and potentially reduce bacteria-related mortality, complications as well as treatment costs added the company.
The US 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, helping patients gain timely access to these medical devices.
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