Huntsville’s iCubate® , which describes itself as a provider of accurate and affordable syndromic diagnostic testing, announced the launch of the iC-COVID19 Assay™ to expand needed coronavirus testing as demand increases.
Diagnostic testing continues to be a key part of efforts to prevent the spread of the coronavirus disease. In the United States, there have been more than 1.5 million COVID-19 cases, resulting in more than 89,000 deaths.
“Many regions of the country are facing barriers to COVID-19 testing. iCubate was eager to join the fight and developed the COVID-19 test for hospitals, clinical laboratories and temporary collection sites in major cities and small towns,” said Carter Wells, CEO of iCubate.
Targeting the S gene and the ORF1ab gene of the SARS-CoV-2 virus, iCubate’s COVID-19 assay was designed to test people exhibiting symptoms of the coronavirus disease. By using the iC-COVID-19 Assay, a result can be generated in less than six hours from the time of sample collection.
“Testing is key to controlling the coronavirus pandemic and the availability of precise and automated tests has been a limitation in many areas,” said Fran White, founder and president of Regulatory Affairs of MDC Associates. “iCubate’s easy-to-use assay offers another option for laboratories to consider in the fight against COVID-19. The iCubate system is highly reliable and easy to install and implement in any laboratory setting.” White and the MDC team work with in vitro diagnostic and medical device companies in the U.S. and around the world to move products through regulatory processes to improve patient health.
With a goal of reducing exposure for front-line health care workers, each iC-COVID19 Assay is performed in a single-use, closed, disposable cassette that is pre-loaded with the reagents necessary to provide a qualitative answer from a single patient sample.
The iC-System has previously earned two 510k FDA clearances for the iC-GPC Assay™ and the iC-GN Assay™ . These assays rapidly detect and identify bacteria associated with bloodstream infections and subsequent sepsis. Additionally, the FDA has designated iCubate’s iC-Myco Assay™ a “Breakthrough Device” for the detection and identification of potentially pathogenic non-tuberculosis Mycobacterium, a major cause of pulmonary infections.
iCubate has submitted the iC-COVID19 Assay to the FDA for Emergency Use Authorization for the detection of the virus that causes COVID-19. iCubate’s submission is pending.