FLOW System for laboratory-developed testing

ROCHE (SIX: RO, ROG; OTCQX: RHHBY) has launched its new FLOW system for use with Laboratory Developed Tests (LDT) in Asia Pacific, Europe, Africa and Latin America.* This user defined system offers full flexibility along the entire workflow chain, from primary sample handling to qPCR result analysis. The system has a broad range of laboratory applications in virology and microbiology. In addition, Roche's comprehensive offering of reagents, controls and assays designed and optimized to work on the FLOW instrumentation, brings a new level of convenience and standardization to laboratories who run a large volume of LDTs.

The FLOW System is a non-IVD system for general laboratory use consisting of 5 components: 1) FLOW Software, 2) FLOW Primary Sample Handling System, 3) MagNA Pure 96 System for automated nucleic acid purification, 4) FLOW PCR Set Up System, and 5) the LightCycler? 480 System for amplification. FLOW Software is able to communicate with the customer's laboratory information system (LIS), receiving sample and associated analysis request information to generate work lists.

This workflow standardization and data automation is designed for applications typically required in laboratories performing laboratory developed testing with diverse molecular test menus, high sample numbers and large target variety. FLOW's software seamlessly connects all process steps, allowing for a new standard of result reliability and reproducibility and provides full traceability of data and direct communication to the laboratory information system (LIS).