Diasorin submitted its 15-minute point-of-care molecular Group A Streptococcus assay, Liaison Nes Group A Strep, to the U.S. Food and Drug Administration for 510(k) clearance and a CLIA waiver. The PCR-based test runs on the Nes point-of-care platform that already has clearance for multiple respiratory pathogens. Diasorin positions the rapid molecular strep assay as a tool to improve antimicrobial stewardship by distinguishing bacterial from viral pharyngitis in outpatient and pediatric settings. The company estimates the U.S. market for Group A Strep testing at roughly $150 million annually and notes the test enables immediate reporting of positive results to accelerate outpatient workflows. If granted a CLIA waiver, the test could reduce confirmatory testing needs and streamline diagnosis in urgent care and primary care clinics, addressing a common cause of antibiotic overprescribing.