(RTTNews) - Roche (RHHBY) announced that it has received the CE Mark for its Elecsys Interferon Gamma Release Assay (IGRA) TB test, a blood-based diagnostic test for identifying tuberculosis infection (TBI) in routine laboratory settings.
Tuberculosis (TB) remains one of the world's most urgent public health challenges and continues to affect millions annually. Diagnosis of tuberculosis infection is essential to breaking the cycle of disease progression and transmission, preventing severe health complications.
Blood-based IGRA tests and tuberculin skin tests are established methods for identifying tuberculosis infections. IGRAs provide a less invasive alternative to skin tests and require only a single patient visit.
According to the company, the new solution provides rapid, high-throughput, and cost-effective tuberculosis testing that delivers reliable results in under 24 hours and cuts standard processing times in half, as the Elecsys IGRA TB assay takes just 19 minutes per patient to process, which is approximately half the time of the currently used method.
The performance of Elecsys IGRA TB was evaluated in a global, multi-centre study conducted in the European, Western Pacific, African regions and America.
Elecsys IGRA TB achieved 91.12% positive per cent agreement (PPA) and 94.57% negative per cent agreement (NPA) when compared to standard of care methods.
Notably, among bacteriologically confirmed TB patients, Elecsys IGRA TB demonstrated a relative sensitivity of 100% compared with an established IGRA method.
Traditional IGRA testing often involves labour-intensive workflows and manual procedures, whereas pairing Roche's new Elecsys IGRA TB test with existing molecular cobas MTB and cobas MTB-RIF/INH assays provides laboratories with an integrated solution for managing both tuberculosis infection and active disease, says Roche.
The Elecsys IGRA TB assay will include a digital tool to fully automate result calculation, interpretation and reporting. In addition, the assay is designed to integrate with third-party automated liquid handlers for front-end processes prior to tube incubation.
"The Elecsys IGRA TB test brings an automated solution for latent TB", said Matt Sause, CEO of Roche Diagnostics.
The firm also highlighted that expanding access to reliable diagnostics remains critical to achieving the World Health Organisation's (WHO) global elimination targets, which aim to decrease tuberculosis deaths by 90% and new cases by 80% by 2030.
RHHBY has traded between $37.51 and $60.85 over the last year. The stock closed Wednesday's trade at $51.76, down 0.79%.
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