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Blu Biotech, U of Michigan to Develop, Seek Approval for Breath-Based Test for Sepsis, ARDS

NEW YORK – Blu Biotech announced on Tuesday a collaboration with the University of Michigan and its Max Harry Weil Institute for Critical Care Research to develop and seek regulatory approval for a breath-based test for sepsis and acute respiratory distress syndrome.

The company and university had earlier reached a licensing agreement that allows Blu Biotech to develop and commercialize a breath test instrument, called the Micro GC, based on the university's gas chromatography photoionization detection technology. They said Tuesday the sepsis and ARDS test will be designed for the instrument.

Financial and other terms of the deal were not disclosed.

Blu Biotech said it plans to seek US Food and Drug Administration approval to market the assay using the Micro GC instrument. Company CEO Robert Tavzel said in a statement that healthcare providers lack methods of quickly detecting sepsis and ARDS or knowing whether interventions are having the intended effects. Earlier detection and improved monitoring could save lives, he said.

Kevin Ward, professor of emergency medicine at the University of Michigan and executive director of the Weil Institute for Critical Care Research and Innovation, said in a statement that the Weil Institute's research into breath-based biomarkers for bedside diagnosis of sepsis and ARDS could lead to methods of monitoring the severity of disease and patient responses to treatment.

"This will also greatly assist in the future development of new therapies for sepsis and ARDS," he said. "Our partnership with Blu Biotech holds the promises to significantly accelerate this work."