iCubate® earns FDA clearance for bloodstream infection detection test

Huntsville, Ala. – iCubate, Inc., an innovative molecular diagnostic device company located on the HudsonAlpha Institute for Biotechnology campus, announced today that it has earned U.S. Food and Drug Administration (FDA) clearance for its platform, the iC-System™, and its first clinical assay, the iC-GPC Assay™, which detects pathogenic bacteria associated with bloodstream infection (BSI).

The iC-GPC Assay™ is the first of the company’s portfolio to earn FDA clearance. iCubate can now market, sell and distribute the cleared products to U.S. Clinical Laboratories.

iCubate was founded in 2009 by Chief Scientific Officer Jian Han, MD, PhD, who is also a HudsonAlpha faculty investigator, with the goal of developing a system that provided faster, more accurate diagnoses and improved, personalized treatments. Being located on the HudsonAlpha campus has allowed iCubate to not only achieve that goal, but accelerate the process of moving innovative research from lab to market.

iCubate is the first company on the HudsonAlpha campus to have a product earn FDA clearance. 

“This major milestone of FDA clearance is a testament to the iCubate team and their dedication to improving patient care through better diagnostics,” said Carter Wells, chief executive officer of iCubate and vice president for economic development at HudsonAlpha. “The collaborative environment at HudsonAlpha with the research labs and companies under one roof allowed us to quickly advance the technology to positively impact patient treatment. 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.”

Han developed iCubate’s core technology, the Amplicon-Rescued Multiplex PCR (ARM-PCR), which detects multiple pathogens simultaneously, to solve a variety of problems in the clinical laboratory.

“Improved patient treatment through personalized diagnostics is the key mission of iCubate,” said 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.”

Understanding sensitivity and specificity within an assay is paramount, Han and the scientific teams at iCubate used the ARM-PCR 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.

The iCubate story highlights the power of the HudsonAlpha idea to application ecosystem. Starting with an idea in HudsonAlpha labs and moving it into a commercial setting is part of the founders’ vision. 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, all located on the HudsonAlpha campus.

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 BSIs, which occur when a pathogenic microorganism enters the bloodstream. Detection of BSIs with conventional microbiological methods may require up to four days to generate bacterial identification and antimicrobial susceptibility test results.

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.

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 ARM-PCR 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 for more information.

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. Opened 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 life sciences entrepreneurship and business growth; 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. HudsonAlpha has become a national and international leader in genetics and genomics research and biotech education, and includes more than 30 diverse biotech companies on campus. To learn more about HudsonAlpha, visit

Forward-Looking Statements

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.

Media Contact:
Margetta Thomas