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FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients

On Feb 8, 2021
@pharminews shared
FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients https://t.co/WV9Hm7jgHQ #news #pharma #clinicalresear https://t.co/Ff6LIkvJie
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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys® GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. This in vitro diagnostic immunoassay is intended for ...

www.pharmiweb.com
On Feb 8, 2021
@pharminews shared
FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients https://t.co/WV9Hm7jgHQ #news #pharma #clinicalresear https://t.co/Ff6LIkvJie
Open

FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients

FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys® GDF-15 assay as a companion ...

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer

Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers Genentech and Blueprint Medicines will co-commercialise Gavreto in the United States FDA also ...

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers

Roche will obtain co-development and co-commercialisation rights for pralsetinib, an investigational, precision therapy in late-stage development for...

Roche Improves Speed and Accuracy of Non-Small Cell Lung Cancer Diagnosis with Launch of Automated Digital Pathology Algorithm

Roche Improves Speed and Accuracy of Non-Small Cell Lung Cancer Diagnosis with Launch of Automated Digital Pathology Algorithm

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE-IVD launch of its automated digital pathology algorithm

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization

/PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has begun shipping the first allotment of its cobas® SARS-CoV-2 Test for COVID-19...

Roche looks to the future of healthcare with its portfolio of innovative diagnostic solutions at EuroMedLab

Roche looks to the future of healthcare with its portfolio of innovative diagnostic solutions at EuroMedLab

Roche looks to the future of healthcare with its portfolio of innovative diagnostic solutions at EuroMedLab