iCUBATE® EARNS FDA “BREAKTHROUGH DEVICE” DESIGNATION FOR LATEST ASSAY

RAPID IDENTIFICATION OF NON-TUBERCULOSIS MYCOBACTERIUM IS NEEDED FOR THE BENEFIT OF PATIENTS WITH PULMONARY INFECTIONS

HUNTSVILLE, AL, August 2, 2019 – iCubate®, provider of accurate and affordable syndromic test systems generating actionable results to healthcare providers, announced today that the company’s iC-Myco Assay™, for the detection and identification of potentially pathogenic non-tuberculosis Mycobacterium (NTM), has been granted designation as a “Breakthrough Device” by the U.S. Food and Drug Administration (FDA).

Using iCubate’s proprietary technology and platform, the iC-Myco Assay directly addresses the shortfalls of current NTM diagnostics. In a single assay, the iC-Myco Assay, a qualitative, multiplexed, in vitro diagnostic test, identifies 6 of the most common NTM species that cause pulmonary infections including Mycobacterium abscessus, Mycobacterium avium, Mycobacterium chelonae, Mycobacterium fortuitumMycobacterium intracellulare and Mycobacterium kansasii. Detection is performed directly from decontaminated sputum samples, saving days to weeks of culture time required for other NTM platforms. In addition, the assay design reduces technician hands-on time, leading to faster time to diagnosis and treatment.

Mycobacterium tuberculosis is an extremely prevalent pathogen with more than 1 billion individuals infected worldwide. However, in much of the developed world, cases of Non-Tuberculosis Mycobacterium generally are equal to or exceed the number of M. tuberculosis cases. In the United States, only about 10,000 M. tuberculosis cases are reported annually while estimates suggest up to 180,000 cases of NTM, accounting for $1.7 billion in treatment costs.

NTM generally infect immunocompromised individuals but are increasingly being found in otherwise healthy patients. Diagnosis of these infections can be time-consuming and complicated. Culture can take up to six weeks to grow some NTM species, and subsequent biochemical speciation can often be unclear. Treatment of NTM infections consists of taking multiple antibiotics for six months to several years to achieve clearance. Additionally, antibiotic resistance is common and successful regimens have yet to be discovered for some species.

With these factors in mind, iCubate saw the need for faster, more accurate diagnostics and submitted preliminary data with a proposal to the FDA for “Breakthrough Device” status. Now, with this designation, iCubate will have greater and more frequent interaction with FDA during the development and regulatory pathway as well as a higher prioritization during the clearance review stage.

“iCubate’s purpose in developing the iC-Myco Assay has been to offer providers and patients better diagnostics to fight pulmonary infections that may be life-threatening, especially for people with compromised immune systems or lung function. Identifying these causative species weeks earlier than current practices will hasten the start of the appropriate antimicrobial therapy” said Carter Wells, CEO of iCubate. “Through this program, the FDA has taken a forward-thinking approach to improving diagnostics and treatments for patients and iCubate is honored to receive this designation.”

 

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About iCubate

iCubate® is a molecular diagnostic company providing accurate and affordable syndromic testing to clinical laboratories. Founded by Jian Han, MD, PhD, iCubate’s core technology, Amplicon-Rescued Multiplex PCR (ARM-PCR), detects multiple pathogens concurrently with high sensitivity and specificity within each assay. iCubate currently offers a comprehensive diagnostic solution for bloodstream infection and subsequent sepsis. iCubate’s assays for gram positive cocci and gram negative rods are both FDA cleared for clinical laboratory use. The portfolio of “sample in-answer out” assays operate on an integrated, intuitive and user-friendly closed system. The end result is improved turn-around time for pathogenic organism identification and detection of important antimicrobial resistance markers. Offering a scalable, cost-effective platform, iCubate offers accurate testing for labs of any size. See iCubate.com for more information.

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.

 

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