New Orleans, La. — During the 115th General Meeting of the American Society of Microbiology, iCubate® Inc., in conjunction with expert microbiologists representing clinical laboratories from around the U.S., released positive pre-clinical data on the company’s diagnostic test for blood stream infection.
The data were generated at the following sites: Dynacare Laboratories/Medical College of Wisconsin in Milwaukee, Wis.; the Laboratory Alliance of Central New York in Liverpool, N.Y.; and University of New Mexico Health Sciences Center/TriCore Reference Laboratories in Albuquerque, N.M.
According to the publication, “Early identification of the organism(s) present in positive blood culture bottles and genetic determinants associated with antibiotic resistance is critical to management of the infection and improving patient outcome.”
“Presenting the results of this study at this outstanding scientific meeting validates the need for iCubate’s innovative technology. Additionally, this is a testament to the dedication of the entire iCubate team”, said Carter Wells, Chief Executive Officer of iCubate®.
iCubate’s iC-GPC™ panel will include the detection of multiple pathogenic targets and antibiotic resistance markers to further aid physicians with diagnosis.
Additional information from the publication states, “the iCubate iC-GPC assay demonstrated high sensitivity and specificity for identification of five gram-positive targets and three resistance markers directly from positive blood cultures.”
“We are excited about the accuracy of this iCubate® diagnostic test and are pleased with the positive feedback from this study. This is the latest positive step in our path toward FDA clearance and making iCubate® products available to improve the healthcare options for physicians and patients,” continued Wells.
iCubate® is seeking FDA clearance as an in-vitro diagnostic test to be used for the identification and detection of Gram-positive bacteria, which are the most common cause of bacterial bloodstream infections. iCubate® is moving forward on a regulatory path with the goal of obtaining FDA 510(k) clearance.
Gram–positive bacteria, such as Staphylococcus, are the most common bacterial contaminants of blood. FDA approval of the iCubate System to detect Gram-positive bacteria has the potential to help physicians better diagnose and treat bloodstream infections.
iCubate®, Incorporated is a privately-held molecular diagnostic company based in Huntsville, Ala. The company is housed in the HudsonAlpha Institute for Biotechnology. The integrated iCubate System enables extraction, multiplexed amplification and detection automatically in a closed and disposable cassette. Currently, iCubate® products are available for non-clinical, research-use only. 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.