Tag Archives: CDx

December, 2018

13 December
Roche to Develop Companion Diagnostic Test to Identify Patients Eligible for Anti-PD-1 Therapy Based on Biomarker Expression

TUCSON, Ariz., Dec. 11, 2018 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it entered into a collaboration with Merck (known as MSD outside the United States and Canada) to develop a companion diagnostic test to identify patients eligible for anti-PD-1 therapy based on the status of …
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12 September
Incyte and Foundation Medicine Partner to Develop Companion Diagnostic for Pemigatinib in Patients with Cholangiocarcinoma

WILMINGTON, Del. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Incyte Corporation (NASDAQ:INCY) and Foundation Medicine, Inc., today announced that the companies have entered into an agreement for the development, regulatory support and commercialization of companion diagnostics (CDx), with an initial focus on CDx development for pemigatinib (INCB54828), Incyte’s selective FGFR1/2/3 inhibitor, in patients with …
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23 August
FDA Approves Roche’s Cobas EGFR Mutation Test v2 as a Companion Diagnostic with Iressa

PLEASANTON, Calif., Aug. 23, 2018 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval from the U.S. Food and Drug Administration (FDA) for the cobas® EGFR Mutation Test v2 as a companion diagnostic test (CDx) with IRESSA®. A CDx test provides information that is essential for the safe …
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24 May
Foundation Medicine and Merck Enter Immuno-Oncology Companion Diagnostics Collaboration

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. (NASDAQ:FMI) today announced a collaboration with Merck, known as MSD outside the United States and Canada, to develop companion diagnostic tests for use with KEYTRUDA®(pembrolizumab), Merck’s anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability (MSI) high or mismatch repair deficient solid tumors. The companion …
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10 April
Illumina and Loxo Oncology Partner for Development of Next-Generation Sequencing-Based Pan-Cancer Companion Diagnostics

SAN DIEGO & STAMFORD, Conn.–(BUSINESS WIRE)–Illumina, Inc. (Nasdaq: ILMN) and Loxo Oncology (Nasdaq: LOXO) today announced a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication. The co-development partnership will …
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1 June
FDA Approves Roche’s Companion Diagnostic to Identify ALK-Positive NSCLC Patients

Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug ZYKADIA (ceritinib). The VENTANA ALK (D5F3) Assay is the …
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