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In Brief This Week: Roche; IVDR; Thermo Fisher Scientific; Centogene; ACCC; More

NEW YORK — Roche this week announced that it has extended its partnership with Hitachi High-Tech for at least another 10 years. The two companies have been collaborating since 1978 and have developed the "serum work area" concept that combines clinical chemistry, ISE, and immunochemistry into one system, Roche said. This year, Roche plans to launch the Cobas C703, the Cobas ISE Neo, and the Cobas Mass Spec instruments developed with Hitachi. 

The European Council this week adopted measures to delay some deadlines of the In Vitro Diagnostic Medical Device Regulation, as well as a gradual rollout of the European Database on Medical Devices. The council also adopted a measure requiring manufacturers to warn of potential shortages of critical medical devices and in vitro diagnostics. The measures were proposed in January by the European Commission, and in April the European Parliament agreed to adopt them. Following this week's action, the measures will become effective upon their publication in The Official Journal of the European Union. 

Thermo Fisher Scientific said this week that its Applied Biosystems CytoScan Dx Assay and Chromosomal Analysis Suite Dx software are now updated to comply with the European Union’s In Vitro Diagnostic Regulation. With the compliance updates, cytogenetics testing laboratories can adapt to the latest medical device safety and efficacy frameworks and conformity assessments using the company’s chromosomal microarray analysis solutions, Thermo Fisher said. 

The Association of Cancer Care Centers (ACCC) this week announced an online resource to support oncology professionals integrating biomarker testing into their electronic health record (EHR) systems. The resource, which ACCC refers to as a virtual roadmap, outlines how multidisciplinary cancer care teams can better incorporate ordering of biomarker testing and structured data from biomarker test results into EHRs. The roadmap was developed in partnership with the LUNGevity Foundation, an organization that funds lung cancer research, and support from AstraZeneca and Genentech. 

Centogene said this week that it received an extension from the Nasdaq on May 13 for continued listing of its stock until Aug. 26. The German molecular diagnostics and genetic testing company said it will need to achieve progress milestones with respect to its strategic alternative review process and regain compliance with the exchange's minimum market value of publicly held shares (MVPHS) requirement as a result of the completion of a transaction by Aug. 26. 

The Department of Health Abu Dhabi (DoH) and Eli Lilly Suisse said this week that they have signed a memorandum of understanding with the goal of collaborating to enhance the care of neurodegenerative patients in the Emirate of Abu Dhabi. Under the agreement the DoH will establish a center of excellence in neurodegenerative disease care that will include therapeutic innovations, advanced diagnostic technologies, and advances in patient monitoring and follow-up protocols. 

Germany's Evaluation Committee has issued regulations for companion diagnostics payment for Menarini Group's Orserdu (elacestrant), a treatment for ER-positive, HER2-negative advanced breast cancer with ESR1 mutations. The standardized evaluation scale (EBM) will now include PCR-based circulating tumor DNA (ctDNA) tests for ESRI mutations and ctDNA tests for PIK3CA and ESR1 mutation status. An existing code for determination of PIK3CA mutation status alone will be deleted from the EBM. The changes go into effect in July. This is because the patient population eligible for Orserdu overlaps significantly with those eligible for Novartis' PI3Kα inhibitor Piqray (inavolisib), for which detection of activating mutations in ESR1 and PIK3CA is required.