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Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.
The firm said that its Cobas CT/NG real-time PCR assay is the first available in the US for the testing of sexually transmitted infections on its 6800 and 8800 systems.
One outcome of a recent FDA workshop about the potential for using self-collection for Pap testing was that it might be better to do self-collection in combination with molecular testing.
The agency cleared two Roche tests that run on its Cobas systems. One does Chlamydia trachomatis and Neisseria gonorrhoeae testing and the other does hematology testing.
Providers are looking to innovation in products and pricing to convince pathologists unsure of the value in switching to digital solutions.
Practice recommendations could serve as a guide for labs considering using the high-sensitivity assays as they become available, authors said.
The firm aims to have its test on the European clinical market by early next year, followed by a launch in the US.
Chugai, a member of the Roche Group, has already filed for regulatory approval of FoundationOne CDx with Japan's Ministry of Health, Labor, and Welfare.
The company plans to grow its business based on the FDA approval and preliminary national coverage determination for its FoundationOne CDx test last year.
The Cobas m 511 combines a cell counter, slide maker and stainer, and a digital morphology analyzer into one integrated solution.