Roche Diagnostics received FDA 510(k) clearance for lab automation modules and secured CE marking for a blood donor screening assay. The company’s Cobas c 703 and Cobas ISE Neo units expand the Cobas Pro Integrated Solutions platform, with stated targets of up to 2,000 chemistry tests per hour and up to 1,800 ISE tests per hour. Roche said the upgrades are intended to improve workflow efficiency and address constraints such as staff shortages and rising test volumes by enabling more continuous throughput and reducing reagent reloads. In a separate announcement, Roche’s molecular Cobas MPX-E assay for blood donor screening received CE marking for a 4-in-1 qualitative PCR workflow detecting HIV-1/2 and hepatitis C, B and E. The combination of instrument clearance and a multiplex assay approval signals continued investment in automating high-volume, risk-sensitive testing pipelines where performance and reliability are central to compliance and turnaround time.