Technology & Devices

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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New Research Shows Rheumatologists See Telemedicine, Advanced Practice Providers as Keys to Managing Growing Demand for Care

DUBLIN, Ohio, June 16, 2020 /PRNewswire/ — Faced with a decreasing number of healthcare providers and growing patient volume as the Baby Boomer generation ages, surveyed rheumatologists said they plan to hire more advanced practice providers (APPs), expand patient care with telemedicine and invest in technology to manage the increased …

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