18/05/2026
We are pleased to announce that TB-SIX has been successfully registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a UK IVD medical device.
This registration marks a significant regulatory milestone, reflecting LyoDx's self-declaration of conformity with the applicable safety and performance requirements under the UK medical device regulatory framework.
TB-SIX is intended for use as:
• an aid in the diagnosis of active tuberculosis (TB) disease; and
• an aid in monitoring the effectiveness of anti-tuberculosis treatment in individuals with confirmed active TB.
Achieving MHRA registration reflects the rigorous technical, quality and clinical work undertaken by the LyoDx team, including the development of a comprehensive technical documentation package and alignment with UK regulatory expectations.
We are proud of this step forward and look forward to progressing TB-SIX into clinical and research settings in the UK and beyond.
To find out more about TB-SIX, visit our website: https://lyodx.com/