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][4]. 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 [5]. - The company has been recognized as one of the most sustainable companies in the pharmaceuticals industry for fifteen consecutive years by the Dow Jones Sustainability Indices, reflecting its commitment to improving healthcare access globally [6]. Product Details - The cobas BV/CV assay addresses the limitations of traditional diagnostic methods, which often yield inaccurate results, leading to delays in treatment. This assay provides accurate and specific results, enabling quicker and more targeted therapies for patients [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 [8]. Market Insights - The global sexual health market segment is valued at CHF 1.1 billion, with an annual growth rate of 11%. Vaginitis is identified as the primary growth driver within this segment, exhibiting a yearly growth rate of 26% [3]. - The cobas BV/CV assay expands Roche Diagnostics' sexual health portfolio by allowing simultaneous testing for BV and CV alongside other sexually transmitted infections, enhancing the capabilities of the cobas 5800/6800/8800 systems [3].