Tuberculosis - the challenge
Tuberculosis (TB), caused by Mycobacterium tuberculosis, is the leading cause of death by infectious disease globally. The WHO estimates that in 2024 10.7 million people fell ill with TB and 1.23 million people died. Additionally, drug resistance in M. tuberculosis is an increasing problem¹.
Rapid, accurate and accessible diagnostics would allow improvements for triage and treatment of patients with TB. Current diagnostic tests rely largely on potentially hard-to-obtain sputum samples or have long turnaround times. Host-response blood-based diagnostics are a current area of interest.
RISK6 explained
TB-HIRA utilises an existing signature, RISK6 which meets the WHO target product profile performance for a TB triage test²³ .
The signature measures the relative expression of six individual mRNA transcripts in a whole blood sample. An algorithm is then applied to generate a score indicative of TB infection statusc³.
RISK6 has demonstrated potential clinical utility in monitoring the response to treatment without the need for culture. It is also expected to be suitable for use in people living with HIV²³.
Simplified Workflow
LyoDx is developing TB-HIRA, a single tube, lyophilised master-mix. With its simplified workflow, reduced turnaround times, increased throughput and easier transportation, TB-HIRA offers a more accessible solution.
The master-mix includes all primers and reagents for quantification of transcripts measured during the RISK6 assay. This allows the relative expression of all six transcripts to be measured in a single multiplexed RT-qPCR reaction on a benchtop thermocycler.
Next Steps
LyoDx are looking for partners to collaborate on the next part of our journey.
- To further validate TB-HIRA against the existing RISK6 signature.
- To include TB-HIRA in triage or treatment monitoring / cure studies.
- To act as an early adopter site for TB-HIRA.