Roche won FDA clearance for two Cobas Pro lab automation units and secured CE marking for a blood donor screening assay, expanding its push to boost high-throughput testing with modular platforms. The Cobas c 703 and Cobas ISE Neo analytical modules are designed for mid- to very-high-volume clinical chemistry and immunochemistry workflows, with Roche citing throughput targets of up to 2,000 and 1,800 tests per hour, respectively. The firm also received CE marking for its molecular Cobas MPX-E blood donor screening assay, a multiplex PCR test intended to detect HIV-1/2 and hepatitis C, B, and E. Roche said the 4-in-1 assay runs on fully automated Cobas x800 systems and includes dual-target HIV-1 group M detection aimed at maintaining sensitivity amid viral mutations. With labs facing staffing shortages and growing test volumes, Roche’s clearances target both capacity and workflow efficiency. The updates add to the company’s broader diagnostics portfolio tied to automation platforms and viral screening operations.