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.
The latest clearance expands the existing FDA-cleared uses of ClonoSEQ for the detection and monitoring of MRD in bone marrow from multiple myeloma and B-cell acute lymphoblastic leukemia patients.
Access to ClonoSEQ for CLL patients nationwide is supported by the already established Medicare coverage of ClonoSEQ in CLL, the company said in an Aug. 6 press release, as well as by the FDA’s clearance of ClonoSEQ testing for CLL patients in blood and marrow.
“We know that traditional CLL treatment response criteria are insufficient, so the ability to measure MRD with a test that is 100 times more sensitive than standard flow cytometry may change our approach to treating CLL,” John Pagel, MD, PhD, principal investigator and chief of hematologic malignancies at Seattle’s Swedish Cancer Institute, said in the release.
CAP urges data reporting rules be rescinded
In a meeting with federal agency officials on Aug. 6, leaders representing the CAP urged the Department of Health and Human Services and Centers for Disease Control and Prevention to rescind new data reporting requirements for laboratories until workable rules can be implemented.
CAP governors Jonathan Myles, MD, and Rajesh Dash, MD, and informatics experts Alexis Byrne Carter, MD, and Joseph Sirintrapun, MD, met with HHS and CDC officials to reiterate that the new data reporting rules are burdensome and, in some instances, impossible for laboratories to comply with. Beginning Aug. 1, laboratories were required to meet the new rules for reporting results from each COVID-19 test provided to patients.
In a June 26 letter to HHS secretary Alex Azar, the CAP had urged the HHS to recognize the challenges that collection and reporting of the expanded data elements would create, especially since some of these data elements are not currently in many laboratory information systems. In the letter, the CAP explained how the data reporting guidance from the HHS and the CDC significantly expanded the requirements for reporting laboratory results with some new data elements that have not historically been required.
Administrative officials told the CAP on Aug. 6 that clinical laboratories should follow the implementation guide to distinguish the required elements versus other requested or optional elements. In addition, no enforcement mechanism has been established, they said, but clinical laboratories should attempt to comply.
CAP leaders said they would further discuss the data rules and compliance issues with the agencies but also maintained that the new rules are unworkable and should be rescinded. A follow-up meeting with agency officials took place Aug. 19.
Latest on COVID-19
Editor’s note: See captodayonline.com for news on SARS-CoV-2 tests (Top News), plus COVID-19 coverage that becomes available between print issues. A list of FDA EUAs for COVID-19 can be found at https://j.mp/covid-19-EUA.