iCubate® will seek 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. Data generated during Beta studies performed at three major reference laboratories throughout the United States verified product performance. iCubate® is moving forward on a regulatory path with the goal of obtaining FDA 510(k) clearance.
“In order to provide the best treatment to patients, physicians need an accurate diagnosis,” said Jian Han, M.D., Ph.D., iCubate founder and chairman. “iCubate® will provide this using groundbreaking multiplex technology and an innovative platform.”
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® uses proprietary ARM-PCR (Amplicon Rescued Multiplex PCR) technology for multiple targets to be amplified in one reaction. This is accomplished through a patent-protected, self-contained, automated, disposable iCubate Cassette using the lab-technician friendly iCubate System.
iCubate’s iC-GPC™ sepsis panel will include the detection of multiple pathogenic targets and antibiotic resistance markers to further aid physicians with diagnosis.
“This is significant milestone in our young company’s growth. We look forward to moving ahead toward clinical approval with the iC-GPC™ panel and others in the near future to improve patient care,” said Carter Wells, Chief Executive Officer.
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.