Funding will support the development of SeptiCyte™ RAPID through FDA 510(k) Clearance
| SEATTLE, Oct. 3, 2019 /PRNewswire/ -- Immunexpress , Inc., a medical diagnostic company focused on improving outcomes for suspected sepsis patients, today announced the closing of a major private funding round. The financing will, firstly, provide Immunexpress with the funding to achieve its immediate corporate goal, the 510(k) clearance of SeptiCyte™ RAPID from the U.S. Food and Drug Administration (FDA) and, secondly, support the commercial launch of the assay. SeptiCyte™ RAPID, the first one-hour, direct-from-blood, host-response assay will aid in the diagnosis of sepsis in critically ill patients. “This financing positions Immunexpress as the clinical and commercial leader in host response sepsis diagnostics,” said Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress. “When cleared, SeptiCyte™ RAPID will be the first rapid, host-response test that distinguishes sepsis from SIRS and provides actionable results in about an hour. We are preparing for commercialization of SeptiCyte™ RAPID across the U.S.” SeptiCyte™ RAPID is the application of Immunexpress’ SeptiCyte™ technology on the Biocartis Idylla™ platform, which aids physicians to swiftly differentiate sepsis from SIRS in critically ill patients. The SeptiCyte™ technology uses proprietary biomarker signatures to assess the response of a patient’s immune system to infections to provide clinically-meaningful data for optimizing treatment. By leveraging the rapid turn-around time of the Idylla™ platform, outcomes are improved and costs reduced. In February 2017, the FDA cleared the manual SeptiCyte™ LAB test. This was a key first step in the regulatory path towards a future FDA clearance of SeptiCyte™ RAPID. The SeptiCyte™ LAB blood test aids in differentiating infection in suspected sepsis patients within four to six hours from a blood sample. The next-generation SeptiCyte™ RAPID blood test uses the same biomarker technology but provides results in approximately one hour – a timeframe that supports the time-critical decision-making required in the management of sepsis patients. Jane Papadaki Markley, Immunexpress’ Vice President of Market Development and Commercial Operations, added, “There is a clear unmet medical need for the adoption of SeptiCyte™ RAPID in hospitals, where the risk stratification of patients with inflammation is challenged due to the lack of a sepsis-specific diagnostic, resulting in therapeutic delays, inappropriate patient management and increased patient mortality. For every hour of delay in diagnosis, the chance of death increases by 8%. Immunexpress has revolutionized host response sepsis detection. It is time to adopt SeptiCyte™ RAPID and our commercial team looks forward to working with hospitals and labs across the country to make this implementation swift and easy.” About Immunexpress Follow Immunexpress on Twitter and LinkedIn. Media Contacts:
SOURCE Immunexpress, Inc. |
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