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 Administration (FDA) clearance for the iC-GN Assay™.
The iC-GN Assay is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria which are associated with bloodstream infection (BSI) and subsequent sepsis. Additionally, the iC-GN Assay detects important gene markers, specific to emerging antibiotic resistance. Assay results provide important diagnostic information that can guide in the early choice of appropriate antimicrobial therapy. Targeted antibiotic treatment results in better patient care and management, thereby shortening hospital stays, reducing institutional costs, and benefiting antimicrobial stewardship programs.
With the previously cleared, iC-GPC Assay, this FDA clearance now completes iCubate’s comprehensive BSI detection solution for clinical laboratories in the United States. Bloodstream infections and subsequent sepsis are associated with high mortality rates that occur frequently in critically-ill, hospitalized patients. Sepsis is the 10th leading cause of death in the U.S. and is responsible for more than $16 billion in direct healthcare costs annually.
“iCubate is proud to join the fight against this unpredictable and deadly condition,” Carter Wells, Chief Executive Officer of iCubate. “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™ detects target DNA and identifies gram negative organisms associated with gram negative bacteremia including Acinetobacter baumannii complex, Escherichia coli and Klebsiella pneumoniae as well as three resistance markers including KPC and NDM, which are associated with resistance to carbapenems.
The companion iC-GPC Assay™ provides identification of five of the most common gram positive organisms associated with gram positive bacteremia, including Staphylococcus aureus. Additionally, the assay identifies three clinically relevant antibiotic resistance markers specific to methicillin resistant Staphylococcus and vancomycin resistant Enterococcus.
“The rapid identification of the clinically relevant bacteria responsible for septicemia and the detection of their gene resistance determinants will have a favorable impact on patient outcomes, antibiotic stewardship programs and hospital costs. The assays are easily performed, load-and-go, affordable tests that require only a minute or two of technologist’s set up time. In addition, the iCubate instrument platform has a small footprint and it’s random access capability of testing up to four positive blood specimens at a time makes it conducive for use by any size laboratory. Importantly, Laboratory Alliance has used the iCubate instrument for several years testing over 1,500 positive blood specimens and there has not been one instance of instrument failure or breakdown.” Paul Granato, PhD, Director of Microbiology, Laboratory Alliance of Central New York, LLC.
iCubate® is a molecular diagnostic company providing accurate and affordable syndromic testing to clinical laboratories. Founded by Dr. Jian Han, MD, PhD, iCubate’s core technology, Amplicon-Rescued Multiplex PCR (ARM-PCR), detects multiple pathogens concurrently with high sensitivity and specificity within each assay. The portfolio of “sample in-answer out” assays operate on an integrated, intuitive, user-friendly closed system. The end result is improved turn-around time for pathogenic organism identification and detection of important antimicrobial resistance markers. Offering a scalable, cost-effective platform, iCubate offers accurate testing for labs of any size. See iCubate.com for more information.
Some statements in this press release may be “forward-looking statements”. iCubate® cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. iCubate undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.