It’s a “breakthrough device” says the U.S. Food and Drug Administration, and one that can save the lives of the thousands who fight life-threatening pulmonary infections each year.
The medical innovation is called the iC-Myco Assay, a diagnostic tool that can speed diagnoses by weeks.
Huntsville-based iCubate developed the iC-Myco Assay, and the FDA in late July gave it the agency’s “breakthrough” certification.
Using the iC-Myco Assay, healthcare providers can identify six of the most common non-tuberculosis Mycobacterium (NTM) that cause pulmonary infections. 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 between 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 NTM 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 case of NTM are reported, accounting for $1.7 billion in treatment costs.
“iCubate’s purpose of 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,” said Carter Wells, CEO of iCubate. “Identifying these causative species weeks earlier than current practices will hasten the start of the appropriate antimicrobial therapy.”
The Breakthrough Device designation will allow iCubate to have more frequent interaction with the FDA during the development and regulatory pathway, as well as higher prioritization during the clearance review stage.