Genedrive® MT-RNR1 Product Range World’s first point of care genetic test used to influence neonatal management in an acute setting and reduce aminoglycoside induced hearing loss An in vitro diagnostic (IVD) molecular assay for use on human buccal cells • Reduces the likelihood of aminoglycoside induced hearing loss • Rapid genetic screening prior to aminoglycoside antibiotics treatment prescription • Non-invasive test, uses buccal swabs to collect samples Advancing diagnostics to the point o

Background • The m.1555A>G is a gene variant of known clinical interest • Individuals with m.1555G gene variant develop profound irreversible hearing loss if exposed to aminoglycoside • In case of suspected Sepsis, antibiotic treatment must be administered within 1 hour of admission to the unit (NICE Guidelines)¹ • It is estimated from population-based studies that the prevalence is 1:500 people that have the m.1555G gene variant • These individuals are highly susceptible to irreversible, bilateral hearing loss, when given gentamicin • Gentamicin (aminoglycoside antibiotic) is the first line...

Current Situation Baby admitted to NICU 499 in 500 Administer gentamicin and benzylpenicillin Administer gentamicin and benzylpenicillin Patient has no loss of hearing Clinician has 1 hour to administer gentamicin and benzylpenicillin Patient has severe loss of hearing MT-RNR1 G variant The solution… Baby admitted to NICU Clinician has 1 hour to administer gentamicin and benzylpenicillin 499 in 500 Not Detected Administer gentamicin and benzylpenicillin Patient has no loss of hearing MT-RNR1 A variant In under 30 minutes clinician uses Genedrive System with Genedrive MT-RNR1 ID Kit to detect...

Genedrive® System The Genedrive System is an automated system used for qualitative in vitro molecular diagnostic tests. The Genedrive System performs tests, using single-use disposable cartridges, allows viewing of results on the touch screen and the ability to export the results. Our new Genedrive System uses patented technology to rapidly amplify and detect target nucleic acid sequences without the requirement for nucleic acid isolation. • Designed to be used as a point of care genetic test • Delivers accurate and rapid patient diagnosis, in just 26 minutes, making it ideal for use in time...

Key Features: • Reduces the likelihood of aminoglycoside induced hearing loss • Provides a clear patient benefit, by informing the clinician ahead of antibiotic treatment decisions • Rapid genetic screening prior to aminoglycoside treatment • Single use, cost effective test for use by healthcare professionals with minimal training • Easy adoption into existing neonatal admissions process • Non-invasive sampling u

MT-RNR1 Genedrive® MT-RNR1 ID Kit 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 test consists of a target DNA amplification step and an end-point melt curve analysis. The data is interpreted by the system software which displays the result clearly on the screen. The average analysis time from sample collection...

MT-RNR1 Genedrive® MT-RNR1 Control Kit The Genedrive MT-RNR1 Control Kit is a qualitative molecular test which enables trained healthcare professionals to perform routine Quality Control testing of the Genedrive System. Genedrive MT-RNR1 Control Kit is used in conjunction with the Genedrive MT-RNR1 ID Kit on the Genedrive System. It tests the ability of the Genedrive System to detect both the positive (detected) and the negative (not detected) variant for the m.1555A>G single nucleotide polymorphism (SNP) affecting the mitochondrial gene MT-RNR1. The Genedrive MT-RNR1 Control Kit is intended...

To learn more about Genedrive® MT-RNR1 Product Range, please visit our website at www.genedrive.com Ordering Information Product Code Product Description Pack Quantity Genedrive System Genedrive Star label printer with charging cradle Replacement Printer Labels References 1. ational Institute for Health and Care Excellence, Neonatal infection: antibiotics N for prevention and treatment, (2021), NICE. 2. liss on hospital admissions to Neonatal Units https://www.bliss.org.uk/ B research-campaigns/neonatal-care-statistics/statistics-about-neonatal-care 3. cDermott J et all. Rapid Point-of-Care Geontyping...