Roche Strengthens Pipeline with Rapid TB Test Launch and Second FDA Fast Track for Gazyva

Roche gains CE mark for rapid TB blood test and FDA priority review for Gazyva in kidney disease, advancing diagnostics and therapeutics beyond oncology.

Roche has notched two regulatory wins in as many days, advancing both its diagnostics and therapeutics businesses with a fast tuberculosis test and a second priority review for the kidney drug Gazyva. The developments underscore the Swiss group’s push to diversify beyond its oncology core while expanding its footprint in high-unmet-need indications.

The diagnostics arm secured CE marking for the Elecsys IGRA TB Test on July 9, 2026, a fully automated blood test that cuts processing time to just 19 minutes per patient. Traditional interferon-gamma release assays require hours of manual labour, limiting throughput. By running on Roche’s widely installed cobas immunoassay systems, the new test allows labs to deliver reliable results within 24 hours while slashing error-prone manual steps. “Better and more accessible tests are the first step” in tackling latent tuberculosis, said Matt Sause, CEO of Roche Diagnostics. The global burden remains enormous: an estimated 10.7 million people fell ill with TB in 2024, and 1.23 million died. With a quarter of the world’s population potentially carrying the bacteria without symptoms, and 5% to 10% of those eventually developing active disease, faster screening tools are critical.

On the therapeutic side, the US Food and Drug Administration has granted priority review to Gazyva for primary membranous nephropathy (pMN), a rare autoimmune kidney disease that currently has no FDA-approved therapy. The designation, announced Wednesday, is based on the Phase III MAJESTY study, which showed that Gazyva significantly outperformed the current standard tacrolimus in achieving complete remission — a key endpoint for preserving renal function in pMN patients. The agency is expected to decide by November 2026.

This marks the second time in months that Gazyva has earned expedited US review. In May 2026, the FDA granted priority review for idiopathic nephrotic syndrome, another kidney condition. Originally developed for hematological cancers, Gazyva is increasingly becoming a pillar of Roche’s immunology and nephrology pipeline. The European Medicines Agency is meanwhile evaluating the drug for lupus nephritis, broadening the therapeutic reach.

Despite the positive news, Roche’s non-voting equity shares (Genussscheine) showed little reaction, closing Tuesday at CHF 323.90. The stock is down 3.39% over the past week and 0.67% over 30 days, reflecting a neutral technical picture with a relative strength index of 47.2 and volatility of 18.34%. The company’s market capitalisation stands at roughly €353.04 billion.

Investors appear to be looking past the regulatory headlines toward a bigger catalyst: the first-half results due on July 23, 2026. Analysts will be watching closely for signs of how well operating growth is holding up against a strong Swiss franc, which has weighed on recent earnings. Gazyva, while a promising pipeline driver, has yet to contribute meaningful revenue, and the TB test’s commercial uptake in European labs will take months to gauge. Whether these developments brighten the outlook at the half-year mark remains to be seen.