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The agency approved Agilent/Dako's PD-L1 IHC test for identifying TNBC patients who are most likely to respond to Keytruda and chemo.
The deals with three quality assessment organizations will contribute to the firm's goal of connecting pharmaceutical companies, diagnostic firms, and laboratories.
The firm expects to launch a tissue-based immunohistochemistry version of the test, which detects QSOX1, in mid-2021, followed by a dipstick plasma-based assay by early 2022.
The acquisition of immunohistochemistry services provider QualTek will augment Discovery's existing histopathology services, the company said.
The College of American Pathologist's 11 recommendations cover quantitative image analysis in HER2 immunohistochemistry testing.
Roche plans to establish a CAP/CLIA-certified protocol for the assay and PhoenixMD will further refine its precision for identifying patients who may benefit from its RSK2 inhibitor.
NeoGenomics estimates that the more than 2,000 community oncologists represent a $2.5 billion testing opportunity. Its CEO called the segment a "strategic priority."
The researchers said the test could predict progression and prognosis among women with breast lesions and could be more reliable than tumor margin inspections.
In some instances, Ventana said, a retrospective review and retesting of clinical cases using the affected dispensers would be necessary.
Lunaphore's LabSat Frozen technology aims to automate biomarker-specific frozen section staining and enable performing IHC assays within minutes.