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 detection and identification of potentially pathogenic gram-negative bacteria which are associated with bloodstream infection and subsequent sepsis.
According to statistics provided by iCubate, bloodstream infections and subsequent sepsis are associated with high mortality rates that occur frequently in critically-ill, hospitalized patients, with sepsis being the 10th leading cause of death in the United States and responsible for more than $16 billion in direct healthcare costs annually.
Carter Wells, iCubate CEO, believes the FDA’s clearance will allow his company to help enhance patient care.
“iCubate is proud to join the fight against this unpredictable and deadly condition,” Wells outlined in a statement. “With the ability to provide reliable and cost-effective assays for detecting BSI to laboratories of any size, we are confident that iCubate will add value for health care providers to improve patient outcomes.”
The iC-GN Assay is the final component of iCubate’s comprehensive system for detecting bloodstream infection. The iC-GN Assay also detects important gene markers specific to antibiotic resistance. Results can provide information that can inform healthcare professionals of the appropriate antimicrobial therapy with the goal being better patient care and shorter hospital stays.
The company highlighted the fact that the iC-GN Assay only requires three minutes of hands-on time as well as its ability to detect 11 targets in a single sample.