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Point of Care.

Genedrive® MT-RNR1 System.

The world’s first point of care genetic test used to influence neonatal management in an acute setting and reduce aminoglycoside induced hearing loss.

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.

  • The new Genedrive System uses patented technology to rapidly amplify and detect target nucleic acid sequences without the requirement for nucleic acid isolation.
  • Delivers accurate and rapid patient diagnosis, in just 26 minutes, making it ideal for use in time critical situations.
  • Allows trained users to perform tests, using single-use disposable cartridges
  • Single use, cost-effective test for use by healthcare professionals with minimal training


Background

Gentamicin (aminoglycoside antibiotic) is the first line treatment for new-born babies who are suspected to be at risk of sepsis (NICE, 2021) Aminoglycosides (antibiotics) are used because they are low cost, broad-spectrum antibiotics. 
In the UK alone approximately 100,000 babies per year will be require specialist neonatal care of which approximately 80-90% will be treated for suspected sepsis using aminoglycosides.


What is aminoglycoside-induced hearing loss (AIHL)?

Most people exposed to gentamicin for prolonged periods will suffer damage to the inner ear. However, around 1:500 people carry the 
MT-RNR1 variant m.1555A>G, who, when receiving aminoglycoside treatment, are highly susceptible to moderate to profound, bilateral permanent hearing loss regardless of dose or length of treatment.


Can we prevent AIHL?

New CPIC guidelines were published (May 2021) for the use of aminoglycosides based on MT-RNR1 genotype. Stating that the use of aminoglycosides should be avoided in individuals with an MT-RNR1 variant associated with an increased risk of aminoglycoside-induced hearing loss. Current sequencing tests used to detect the variant take 2-5 days to deliver a result, therefore they are unsuitable for use in an acute setting.


The Genedrive solution for use in time-sensitive settings

The Genedrive® MT-RNR1 ID Kit is a qualitative in vitro molecular diagnostic test for the rapid detection of the single nucleotide polymorphism (SNP) m1555A>G affecting the mitochondrial gene MT-RNR1 in human buccal cells. 
 

*Inspiration Healthcare is the authorised distributor for the Genedrive® MT-RNR1 System in the United Kingdom and Ireland.


References:
NICE Guideline, No 195 Neonatal infection: antibiotics for prevention and treatment (2021)
McDermott JH, Wolf J, Hoshitsuki K, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for the Use of Aminoglycosides Based on MT-RNR1 Genotype. Clin Pharmacol Ther. 2022;111(2):366-372. doi:10.1002/cpt.2309
McDermott JH, Mahood R, Stoddard D, et al. Pharmacogenetics to Avoid Loss of Hearing (PALOH) trial: a protocol for a prospective observational implementation trial. BMJ Open 2021;11:e044457. doi: 10.1136/bmjopen-2020-04445
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