Technology & Devices

Thermo Fisher Scientific Signs Companion Diagnostic Agreement with Chugai Pharmaceutical

CARLSBAD, Calif., July 8, 2020 /PRNewswire/ — Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Chugai Pharmaceutical Co., Ltd., a member of the Roche Group, and has applied to the Ministry of Health, Labour and Welfare (MHLW) to expand the use of the Oncomine Dx Target Test …

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CENTOGENE Receives FDA Emergency Use Authorization for COVID-19 Molecular Diagnostic Test

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, July 02, 2020 (GLOBE NEWSWIRE) — Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, today announced that the U.S. Food and Drug Administration (FDA) …

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Carmine Therapeutics and Takeda Collaborate to Develop Rare Disease Gene Therapies Using Novel Red Blood Cell Extracellular Vesicles Platform

CAMBRIDGE, Mass., June 30, 2020 /PRNewswire/ — Carmine Therapeutics announced today that it has signed a research collaboration agreement with Takeda Pharmaceutical Company Limited (“Takeda”) to discover, develop and commercialize transformative non-viral gene therapies for two rare disease targets using Carmine’s REGENT(TM) technology, based on red blood cell extracellular vesicles. …

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Medtronic Announces FDA Approves First-Of-Its-Kind Percept PC Neurostimulator with BrainSense Technology

DUBLIN, June 25, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announces it received Food and Drug Administration (FDA) approval for the Percept™ PC Deep Brain Stimulation (DBS) system. BrainSense™ technology makes Percept the first and only DBS neurostimulation system with the ability to chronically …

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New Study Demonstrates the Ability of myPath Melanoma to Accurately Classify Lesions Ruled Indeterminate by Standard Pathological Assessment

SALT LAKE CITY, June 25, 2020 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today that a new study published in Future Medicine demonstrates the ability of myPath® Melanoma to accurately classify skin lesions ruled indeterminate by standard pathological review.  “This validation study for …

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Schrödinger Expands Discovery Efforts for COVID-19 Alliance with Advanced Molecular Simulation Leveraging High-Powered Parallel Computing on Google Cloud

NEW YORK–(BUSINESS WIRE)–Schrödinger (Nasdaq: SDGR), whose physics-based software platform enables discovery of high-quality, novel molecules for therapeutics and materials, today announced a significant expansion of its work to discover novel antiviral therapeutics for COVID-19 as a part of a philanthropic global initiative. The accelerated pace, including the evaluation of billions …

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Thermo Fisher Scientific and Daiichi Sankyo to Co-Develop Global Companion Diagnostic for Patients with Non-Small Cell Lung Cancer

CARLSBAD, Calif., June 23, 2020 /PRNewswire/ — Thermo Fisher Scientific and Daiichi Sankyo have expanded their partnership by signing a new agreement to co-develop a companion diagnostic (CDx) that will utilize Thermo Fisher’s next-generation sequencing (NGS)-based Oncomine Dx Target Test. The CDx will be designed to identify non-small cell lung …

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Roche Receives FDA Approval for cobas EZH2 Mutation Test as a Companion Diagnostic for Patients with Follicular Lymphoma

INDIANAPOLIS, June 19, 2020 /PRNewswire/ –Roche (SIX: RO, ROG;OTCQX: RHHBF) today announced U.S. Food and Drug Administration (FDA) approval of the cobas® EZH2 Mutation Test as a companion diagnostic for TAZVERIK™(tazemetostat), developed by Epizyme, Inc. This molecular test detects abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients with follicular lymphoma …

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Illumina Acquires BlueBee to Accelerate Processing, Analysis and Sharing of Next Generation Sequencing Data at Scale

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) is enhancing its capabilities to analyze and interpret the data produced by its sequencing systems with the acquisition of BlueBee, a cloud-based software company that provides genomics analysis solutions for research and clinical customers. Based in the Netherlands, BlueBee has developed a regulatory compliant, secure …

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FDA Approves FoundationOne®CDx as the First Companion Diagnostic to Identify Patients with Solid Tumors that are Tumor Mutational Burden-High and Appropriate for Treatment with Keytruda

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®CDx as a companion diagnostic for KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, which was also approved under accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 …

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