THE iC-MYCO ASSAY WAS RECENTLY DESIGNATED “BREAKTHROUGH DEVICE” BY FDA
ANAHEIM, CA, August 8, 2019 – At the 71st Annual American Association of Clinical Chemistry Scientific Meeting and Clinical Lab Expo, iCubate®, a provider of molecular diagnostic solutions for infectious disease detection, presented data on the company’s iC-Myco Assay. iCubate’s latest assay for the detection and identification of potentially pathogenic non-tuberculosis Mycobacterium (NTM) was recently designated as a “Breakthrough Device” by the U.S. Food and Drug Administration.
“Faster and more accurate diagnostics are needed by patients with Mycobacterium infections and iCubate has developed a unique assay to meet this need,” said Katie Heflin Hahnemann, PhD, iCubate’s Manager for Regulatory Affairs and Product Development. “Being able to present the iC-Myco Assay during the poster sessions at AACC provided the global scientific community the opportunity to view the data first hand and see where iCubate is going with this necessary assay.”
Mycobacterium tuberculosis is a pathogen infecting more than 1 billion individuals worldwide. However, in much of the developed world, cases of Non-Tuberculosis Mycobacterium may 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.
Improvements in current diagnostic methods are needed for patients with pulmonary infections. These infections may be life-threatening, especially for people with compromised immune systems or lung function. Diagnosis 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. Identifying these causative species weeks earlier than current practices will allow the patient to start the appropriate antimicrobial therapy sooner.
The FDA designation for the iC-Myco Assay came shortly after iCubate received notice of clearance by the FDA of the iC-GN Assay, which completes the company’s development and launch of a comprehensive diagnostic solution in the fight against bloodstream infections and subsequent sepsis.
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 and CE Marked 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 or call 855-256-3330 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.