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 iCubate® 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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Myco Currently in Regulatory Process

iC-MYCO Assay

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Myco
Currently in Regulatory Process