Currently in Regulatory Process

iC-MYCO Assay

FDA designated the iC-Myco a “Breakthrough Device in June 2019 for the detection and identification of potentially pathogenic non-tuberculosis Mycobacterium, which may cause pulmonary infections.

Mycobacterium NTM Current Diagnoses and Treatment iC-Myco Description and Benefits Mycobacterium Species
  • Mycobacterium are one of the top 10 causes of death worldwide, accounting for 1.7 million deaths in 2016.
  • Mycobacterium tuberculosis is the most virulent, posing critical health concerns.
  • Non-Tuberculosis Mycobacterium (NTM)
  • NTM is more prevalent than TB in most developed countries.
  • Estimated 180,000 cases in the US, increasing by ~8% annually.
  • Lung imaging (X-ray or CT scan) and a positive culture are required for diagnosis.
  • Multiple antibiotics for 6 months to years
  • Multiple follow-up visits for culture monitoring
  • Quarantine and prophylaxis possible
  • Treatment options vary depending on species and AST results
  • Provides a diagnostic result days to weeks sooner than conventional methods
  • Run time: 5 hours
  • Direct from sample with no processing outside of standard practices
  • Direct from acid fast positive decontaminated sputum processed through the NALC/NaOH method
  • Direct from culture
  • Sensitivity 1×10^4 to 1×10^5 cfu/ml
Mycobacterium intracellulare

Mycobacterium abscessus

Mycobacterium chelonae

Mycobacterium fortuitum

Mycobacterium avium

Mycobacterium kansasii

For research use only

The iCubateĀ® system is the cost-effective molecular diagnostic solution providing clinical microbiology labs rapid syndromic testing for infectious diseases, leading to better care sooner.

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