Findings published in the Journal of Clinical Microbiology
Huntsville, Ala. — November 5, 2015 — The iCubate iC-GPC Assay, a test developed by the Huntsville, Ala. company for the rapid identification of gram positive bacteria, showed high levels of efficacy in a clinical setting.
The research findings have been published online first in The Journal of Clinical Microbiology and will appear in the journal’s December print publication.
Authors are Blake W. Buchan and Garrett C. Reymann, the Medical College of Wisconsin and the Wisconsin Diagnostic Laboratory; Paul A. Granato, the Laboratory Alliance of Central New York, LLC and the Department of Pathology, SUNY Upstate Medical University; and Brenda R. Alkins, Patricia Jim and Stephen Young, Tricore Reference Laboratory and the University of New Mexico.
At those clinical sites, the iCubate iC-GPC Assay was evaluated using 203 clinical and seeded specimens containing five gram-positive bacterial species and three associated genetic resistance determinants in positive blood culture broths. The assay demonstrated sensitivity of over 93 percent and specificity of 98-100 percent.
According to the publication, “the iC-GPC assay provides a molecular option for the rapid, on-demand analysis of positive blood cultures.”
The paper also cites possible advantages of the product. “A potential benefit of the iC-GPC assay is the use of a single, closed-system consumable cassette. This enables simplified assay set-up (< 5 min. hands on time) and also aids in reducing the risk of aerosolization of potentially infectious organisms and amplicon contamination. Furthermore, the iC- Processor is capable of random-access processing of up to 4 iC-cassettes simultaneously using an instrument that has a small footprint. Combined, these attributes may positively impact safety, workflow, and throughput when compared to other currently available FDA- cleared molecular platforms and assays for the direct identification of bacteria present in positive blood cultures” (emphasis added by iCubate).
“These findings are an important milestone for the company. We are one step closer to having this product available to help healthcare providers better treat their patients,” said Carter Wells, CEO of iCubate®.
“Combining the innovative arm-PCR technology pioneered by Jian Han, MD, PhD, iCubate’s Founder and Chairman, along with our talented team members, iCubate is positioned for success in this growing market,” continued Wells.
iCubate’s iC-GPC™ panel will include the detection of multiple pathogenic targets and antibiotic resistance markers to further aid physicians with diagnosis.
The iCubate® product is currently “Research Use Only”. These data were collected from an initial beta trial evaluation of the iC-GPC™ product.
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 currently conducting full clinical trials and 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.
About HudsonAlpha: HudsonAlpha Institute for Biotechnology is a nonprofit institute dedicated to innovating in the field of genomic technology and sciences across a spectrum of biological challenges. Founded in 2008, its mission is four-fold: sparking scientific discoveries that can impact human health and well-being; bringing genomic medicine into clinical care; fostering biotech entrepreneurship; and encouraging the creation of a genomics-literate workforce and society. The HudsonAlpha biotechnology campus consists of 152 acres nestled within Cummings Research Park, the nation’s second largest research park. Designed to be a hothouse of biotech economic development, HudsonAlpha’s state-of-the-art facilities co-locate nonprofit scientific researchers with entrepreneurs and educators. The relationships formed on the HudsonAlpha campus encourage collaborations that produce advances in medicine and agriculture. Under the leadership of Dr. Richard M. Myers, a key collaborator on the Human Genome Project, HudsonAlpha has become a national and international leader in genetics and genomics research and biotech education, and includes 29 diverse biotech companies on campus. To learn more about HudsonAlpha, visit: http://hudsonalpha.org/.
About iCubate®: 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.
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iCubate Media contact:
Katie Heflin, iCubate®
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.