Roche launches new PCR test to help improve diagnostic accuracy for women affected by vaginitis in countries following the CE Mark

Core Viewpoint - Roche has received the CE Mark for its cobas® BV/CV assay, which accurately identifies bacteria and yeast responsible for bacterial vaginosis (BV) and candida vaginitis (CV) in vaginal samples, enhancing diagnostic accuracy and treatment efficiency for symptomatic patients [1][5]. Company Overview - Roche, founded in 1896 in Basel, Switzerland, is the world's largest biotechnology company and a leader in in-vitro diagnostics, focusing on improving healthcare through scientific excellence and personalized healthcare solutions [6]. Product Details - The cobas BV/CV assay provides accurate and specific results, addressing the limitations of traditional diagnostic methods like microscopy and pH testing, which often yield inaccurate results and delay treatment [2][3]. - The assay is designed to improve diagnostic accuracy for millions of women affected by vaginitis annually, using a single vaginal swab for broader sexual health testing, thus streamlining the diagnostic process [9]. Market Insights - The global sexual health market is valued at CHF 1.1 billion, with an annual growth rate of 11%, and vaginitis is identified as the primary growth driver with a yearly growth rate of 26% [4]. - The cobas BV/CV assay expands Roche's sexual health portfolio by enabling simultaneous testing for BV, CV, and a range of sexually transmitted infections, enhancing the capabilities of the cobas 5800/6800/8800 systems [4].