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.

 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 status²³.

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.

 LyoDx is developing the TB-HIRA to support the global fight against the challenge of tuberculosis.

TB-HIRA comprises a single tube master-mix including 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.