Roche (RHHBY) announced that it has received the CE Mark for its Elecsys Interferon Gamma Release Assay (IGRA) TB test, a blood-driven diagnostic test for detecting tuberculosis infection (TBI) in the routine laboratory sector.
Tuberculosis (TB) remains one of the globally most emergency public health challenges and continues to affect millions yearly. Diagnosis of tuberculosis infection is significant to breaking the cycle of disease transmission and progression, preventing severe health challenges.
Blood-driven IGRA tests and tuberculin skin tests are established processes for detecting tuberculosis infections. IGRAs offer a less invasive substitute to skin tests and need only a single patient visit.
Based on the company, the novel service provides rapid, high-throughput, and affordable tuberculosis testing, which delivers reliable output in under 24 hours and cuts standard dispensation times in half, as the Elecsys IGRA TB assay takes just 19 minutes per patient, which is approximately half the time of the presently used processes.
The performance of Elecsys IGRA TB was assessed in a worldwide, multi-centre research conducted in the European, Western Pacific, African regions, and the Americas. Elecsys IGRA TB achieved 91.12% positive per cent agreement (PPA) and 94.57% negative per cent agreement (NPA) as compared to standard of care processes. Unusually, in bacteriologically confirmed TB patients, Elecsys IGRA TB demonstrated a relative sensitivity of 100% as compared with an established IGRA process.
Old-style IGRA testing often includes labour-intensive workflows and manual procedures, while pairing Roche's novel Elecsys IGRA TB test with presenting molecular cobas MTB and cobas MTB-RIF/INH assays offers laboratories with an integrated service for managing both tuberculosis infection and active disease, says Roche.
The Elecsys IGRA TB assay involves a digital tool to fully automate output calculation, reporting, and interpretation. Furthermore, the assay is intended to incorporate with third-party automated liquid handlers for front-end processes before tube incubation.
"The Elecsys IGRA TB test brings an automated solution for latent TB", said Matt Sause, CEO of Roche Diagnostics.
According to Towards Healthcare, the mycobacterium tuberculosis market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 820.23 million in 2025 to approximately USD 1,385.79 million by 2034, representing a compound annual growth rate (CAGR) of 6% from 2025 to 2034, driven by increasing demand for mycobacterium tuberculosis (TB) therapeutics is driven by a steady increase in worldwide cases, the increasing prevalence of drug-resistant strains, and the acceptance of shorter, multi-drug regimens using novel agents such as bedaquiline. The standard 6-month therapy for drug-susceptible TB lasts, but demand is shifting toward novel, WHO-recommended regimens. Protocols such as the 6-month BPaLM regimen (Bedaquiline, Pretomanid, Linezolid, Moxifloxacin) yield an 89% treatment success rate for multidrug-resistant (MDR) or rifampin-resistant TB. The quick emergence of Multi-Drug Resistant and Extensively Drug-Resistant (XDR-TB) strains needs challenging healthcare intervention and immediate isolation approaches.
The firm also highlighted that increasing access to dependable diagnostics remains significant to attaining the World Health Organisation's (WHO) worldwide elimination targets, which aim to lessen tuberculosis deaths by 90% and new cases by 80% by 2030.
RHHBY has traded between $37.51 and $60.85 over the previous year. The stock closed at $51.76, down 0.79%.
Roche is a healthcare company uniquely placed to prevent, stop, and cure diseases by uniting leading science and technology in digital solutions, medicines, and diagnostics. Roche Holding AG is a Swiss healthcare company. Across its Diagnostics and Pharmaceutical divisions, Roche focused on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases, and immunology with the goal of offering real and positive change for patients, the people they love, and the professionals who care for them. It operates via the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical partition comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business regions: centralized and point of care solutions, molecular diagnostics, tissue diagnostics, and diabetes care.
A recent report by Towards Healthcare highlights that the Mycobacterium tuberculosis market is witnessing growth because the rising demand for Mycobacterium tuberculosis as tuberculosis (TB) presents significant complexities as a worldwide public health problem, specifically at a time of rising complexities to some particular patients, such as human immunodeficiency virus (HIV) infection and multidrug-resistant (MDR) and extensively drug-resistant (XDR) strains of Mycobacterium tuberculosis. Mycobacterium tuberculosis is an ancient and highly harmful successful human pathogen.
