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Genedrive - MT-RNR1 ID Kit
World’s first point of care genetic test used to influence neonatal management in an acute setting and reduce aminoglycoside induced hearing loss, Prevention - reduces the likelihood of aminoglycoside induced hearing loss, Rapid results - point-of-care genetic test yields results in 30 minutes, Simple to use - by healthcare professionals with minimal training.
An in vitro diagnostic (IVD) molecular assay for use in human buccal cells
The Genedrive® MT-RNR1 ID Kit used in conjunction with the Genedrive® System provides an automated result of an individual`s MT-RNR1 m.1555 variant status to inform the clinician ahead of antibiotic treatment decisions.
The Genedrive® MT-RNR1 ID Kit is intended to be used by healthcare professionals within a near patient setting.
The Genedrive® System is a compact benchtop system that provides rapid nucleic amplification, detection and result reporting without the need for data interpretation
Reduces the likelihood of aminoglycoside induced hearing loss
Provides a clear patient benefit by informing the clinician ahead of prescription
Rapid genetic screening prior to aminoglycoside treatment
Individuals with the MT-RNR1 m.1555A>G variant develop profound irreversible hearing loss if exposed to aminoglycoside - population-based studies estimate prevalence of 1:500 (0.2%)
Single use, cost effective test for use by healthcare professionals with minimal training
Easy adoption into existing neonatal admissions process to inform clinicians ahead of antibiotic treatment decisions
Non-invasive test using buccal swabs from the inner cheek
Time to Result: 26 minutes
Sample Type: Buccal swab
Pack Size: 10 tests per pack
Intended Use: In vitro diagnostic (IVD) molecular assay for the detection of the single nucleotide polymorphism (SNP) m.1555A>G affecting the mitochondrial gene MT-RNR1 in human buccal cells
Specificity: 100%
Sensitivity: 100%