Huntsville, Ala. August 10, 2017 – iCubate®, Inc., an innovative molecular diagnostic device company, announced today that it has earned U.S. Food and Drug Administration (FDA) clearance for its iCubate platform, the iC-System™, and its first clinical assay, the iC-GPC Assay™, used for the rapid detection of pathogenic bacteria associated with bloodstream infection (BSI).
The FDA clearance allows iCubate to market, sell and distribute the cleared products to U.S. Clinical Laboratories.
“This major milestone of FDA clearance is a testament to the dedication of the iCubate team and their commitment to improving patient treatment through better diagnostics,” said Carter Wells, Chief Executive Officer of iCubate. “We are looking forward to providing this product to the clinical laboratories that need better options to identify organisms and resistance markers associated with bloodstream infection.”
iCubate’s core technology, the AmpliconRescued Multiplex PCR (ARMPCR), which detects multiple pathogens simultaneously, was developed by company founder and Chief Scientific Officer, Jian Han, M.D., Ph.D. Dr. Han developed ARMPCR to solve a variety of problems in the clinical laboratory. Understanding sensitivity and specificity within an assay is paramount, Dr. Han and the scientific teams at iCubate used the ARMPCR technology to develop a reliable, easy to use, closed system, as well as a robust clinical assay for the identification and detection of diagnostically important bacteria and resistance markers directly from a positive blood culture.
“Improved patient treatment through personalized diagnostics is the key mission of iCubate,” said Dr. Han. “The iCubate assay provides a new tool to physicians that will allow for improved patient management through the rapid identification of bacteria and resistance markers, which accomplishes that goal.”
The iC-GPC Assay™ is a multiplexed, in vitro diagnostic test for the identification of potentially pathogenic bacteria and clinically significant resistance markers, to aid in the diagnosis of BSI.
The iCubate platform and assay provides results up to 48 hours faster than conventional methods. The 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 iC-System™, the iC-GPC Assay™ and proprietary software were all developed, designed and manufactured by iCubate’s scientific staff, engineers and software developers.
BSIs occur when a pathogenic microorganism enters the bloodstream. Detection of BSIs with conventional microbiological methods may require 24 days to generate bacterial identification and antimicrobial susceptibility test results. According to recent studies, BSIs and subsequent sepsis occurs at an approximate rate of 300 cases per 100,000 people per year in the U.S. Sepsis and the ensuing complications are now the 10th leading cause of death in the U.S. with case numbers rising annually. Improved time to result allows for a targeted approach to antimicrobial treatment. BSIs carry a significant economic cost, with the total burden estimated to exceed $16 billion annually. Targeted treatment can result in better patient management thereby reducing associated costs.
The iC-GPC™ Assay is the first of the company’s portfolio to earn the FDA Clearance.
About iCubate®: iCubate®, Incorporated is a privately-held molecular diagnostic company located in the HudsonAlpha Institute for Biotechnology. iCubate’s mission is to provide a personal diagnosis having an immediate and intelligent impact on patient lives. The integrated iCubate System (iC-System™) enables extraction, multiplexed amplification and detection automatically in a closed and disposable cassette. iCubate provides a sample in-answer out diagnostic test with highly multiplexing ARMPCR technology and a user friendly, flexible platform. Other iCubate products are available world-wide for non-clinical, research-use only in the areas of health, agriculture, food safety and defense. 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.