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IHC

Based on full approval from the FDA based on the Phase III CROWN trial, Pfizer can now market the drug as a front-line option for ALK-positive NSCLC patients.

Advanced NSCLC patients must have a PD-L1 expression tumor proportion score of 50 percent, and no EGFR, ALK, or ROS1 alterations, to receive the drug.

The companies will work with labs to improve payors' understanding of the costs of performing PD-L1 testing and the value it provides to patient care.

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."

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