CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Roche launches Preanalytical System, announces FDA OK for HER2 Dual ISH test as CDx
September 2020—Roche launched its Cobas Prime Preanalytical System to improve efficiency in molecular diagnostics laboratories. It is now commercially available in the United States and markets accepting the CE mark.
The system is designed to automate all preanalytic steps and features cross-contamination control of samples. It has track-connectable modular configurations with one workflow for multiple sample types, end-to-end automation with predictable lab turnaround time, and IT integration with sample and test tracking.
In other news, Roche announced the FDA’s approval of its new Ventana HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for trastuzumab therapy.
The Ventana HER2 Dual ISH DNA Probe Cocktail assay is an enhanced version of the previous-generation test. It was launched as a CE IVD in spring 2019.
Sysmex releases Caresphere Workflow Solution
Sysmex America announced the availability of its new clinical software application, Caresphere Workflow Solution (WS). Designed to address data privacy security and compliance concerns, Caresphere WS delivers workflow efficiency increases to laboratories, Sysmex says. It is Hitrust CSF certified and an intuitive, cloud-based software solution that enables sophisticated test result workflow optimization so laboratories can meet increasing demands, streamline decision-making, and reduce risk.
“Sysmex America’s Caresphere WS is in direct response to escalating health care demands and laboratory staffing constraints,” Andy Hay, chief operating officer of Sysmex America, said in an Aug. 3 statement. “Caresphere WS is simple to implement, highly secure, and provides laboratorians with organized clinical data, standardized result interpretation and autoverification, and comprehensive reports for regulatory compliance.”
Caresphere WS is a HIPAA-compliant application hosted by Amazon Web Services. Sysmex says it supports the entire implementation process from the initial build to go-live and continues support with real-time monitoring, security updates, unlimited training, and technical assistance for the life of the solution. As part of the implementation, the rules and configuration wizards enable customization and standardization of processing and resulting across multisite laboratories and laboratory information systems.
In other news, Sysmex America announced an exclusive agreement with Siemens Healthineers that grants North American rights to distribute and service Siemens Healthineers Clinitek Novus Automated Urine Analyzer for hospital and reference laboratory use. Sysmex said the Clinitek Novus Urine Analyzer completes its automated urinalysis portfolio.
Sysmex America will distribute the analyzer as a fully integrated component of the company’s portfolio of UN-Series instruments and as a standalone product, both with full-service support provided by Sysmex.
Expanded FDA clearance for ClonoSEQ assay to assess MRD in CLL
Adaptive Biotechnologies received clearance from the Food and Drug Administration for its ClonoSEQ assay to detect and monitor minimal residual disease in blood or bone marrow from patients with chronic lymphocytic leukemia.