Una Health is proud to announce that the Credo Vita SIRO Solo instrument and the MT-RNR1 SNP Assay have now officially achieved CE marking – a significant milestone that brings rapid, point-of-care genetic testing closer to routine clinical use across the UK.

This advancement represents a major step forward in protecting vulnerable newborns from preventable, lifelong harm.

Protecting Babies from Aminoglycoside-Induced Hearing Loss

Aminoglycoside antibiotics (such as gentamicin) are widely used in neonatal and paediatric care for severe infections. However, babies with a specific genetic variant in the MT-RNR1 gene are at risk of profound, irreversible hearing loss after exposure to these antibiotics.

Genetic testing for the MT-RNR1 variant has often required laboratory processing, leading to delays that make real-time clinical decisions difficult.

The newly CE-marked Credo Vita SIRO Solo MT-RNR1 Assay changes that.

MT-RNR1 Assay: Critical Results in Just 20 Minutes

The MT-RNR1 assay provides rapid, actionable insight into a newborn’s genetic susceptibility to aminoglycosides, enabling more informed, safer prescribing decisions.

Key Features

Seamless connectivity – The Vita SIRO solo offers bi-directional connectivity of results to POCT middleware using POCT1-A. 

Results in 20 minutes
Rapid turnaround enables true point-of-care decision making, supporting time-critical neonatal pathways.

Simple buccal swab sample
Non-invasive, gentle, and easy to perform at the bedside – no blood draw required.

Why This Matters for UK Healthcare

Hearing loss linked to aminoglycoside exposure is preventable, but only if clinicians know the genetic risk before treatment begins.

The combination of Vita SIRO Solo and the MT-RNR1 assay introduces a practical, scalable solution for NHS Trusts aiming to:

• Reduce the incidence of avoidable hearing loss in newborns
• Improve patient safety and outcomes in neonatal and paediatric wards
• Support antimicrobial stewardship with personalised prescribing
• Bring genetic insight to the bedside without laboratory constraints
• Integrate precision medicine into urgent care pathways

The assay’s speed and simplicity align with the UK’s growing emphasis on rapid diagnostics, genomic medicine, and early intervention, making it a powerful tool for modern neonatal care.

About the Credo Vita SIRO Solo Instrument

The Credo Vita SIRO Solo is a compact, fully integrated point-of-care molecular testing system designed for rapid genetic and infectious disease testing. Its intuitive workflow allows healthcare professionals to perform highly sensitive assays without specialised laboratory training or equipment.

The addition of CE-marked assays, including MT-RNR1, significantly expands the platform’s clinical utility across neonatal, paediatric, and emergency care.

Supporting the Future of Precision Newborn Care

Una Health is committed to providing diagnostic technologies that improve patient safety, deliver fast, reliable answers, and support the evolving needs of clinicians across the UK.

The CE marking of the Credo Vita SIRO Solo and MT-RNR1 assay marks an important leap forward in precision neonatal medicine, helping protect the hearing and long-term quality of life of countless babies.