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iCubate to join the fight against COVID-19 iCubate plans to soon offer a diagnostic test for COVID-19. iCubate’s COVID-19 assay will run on the company’s FDA-cleared, fully automated, random access system for the rapid detection of infectious pathogens. iCubate has contacted FDA to initiate the Emergency Use Authorization process. Due...

When person-to-person spread has occurred with other coronavirus types such as MERS and SARS, it is thought to have happened mainly via respiratory droplets produced when an infected person coughs or sneezes, similar to how influenza and other respiratory pathogens spread. Spread of SARS and MERS between people has generally...

YELLOWHAMMER, July 23, 2019 – A Huntsville biotech company announced that it has obtained U.S. Food and Drug Administration (FDA) clearance to provide clinical laboratories with an innovative testing system for bloodstream infections and sepsis. iCubate has obtained clearance for its iC-GN Assay which is a diagnostic test for the...

HUNTSVILLE, AL, July 22, 2019 – It has been a month of milestones for iCubate with our iC-GN Assay™ receiving CE IVD Marking and US FDA clearance. We look forward to talking about this and what is next for iCubate at the AACC conference in August. iCubate now provides a...

NOW PROVIDING U.S. CLINICAL LABORATORIES A COMPREHENSIVE DETECTION SOLUTION IN THE BATTLE AGAINST BLOODSTREAM INFECTIONS AND SUBSEQUENT SEPSIS   HUNTSVILLE, AL, July 12, 2019 – iCubate®, provider of accurate and affordable syndromic test systems generating actionable results to healthcare providers, announced today that it has obtained U.S. Food and Drug...

NEW YORK (360Dx), June 28, 2019 – iCubate said today that it has secured CE IVD Marking for its iC-GN Assay for the detection and identification of pathogenic gram-negative bacteria and clinically relevant resistance markers associated with bloodstream infections and subsequent sepsis. The firm said that the CE mark allows...