Technology & Devices

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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FDA Grants Breakthrough Device Designation to Thermo Fisher’s Oncomine Precision Assay to Identify IDH1 and IDH2 Mutations in Low-Grade Glioma Patients

CARLSBAD, Calif., June 15, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Thermo Fisher Scientific’s Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881). The …

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Foundation Medicine Acquires Lexent Bio to Accelerate Liquid Biopsy R&D and Advance Cancer Care

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc., today announced that it has completed the acquisition of Lexent Bio, Inc., a precision oncology company located in California, developing novel multiomics liquid biopsy platforms to advance cancer care. This acquisition will accelerate Foundation Medicine’s research and development strategy and expand its existing liquid biopsy …

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New Peer-Reviewed Study Finds That Doctor On Demand Video Visits Foster Physician-Patient Relationships and Drive Patient Satisfaction

SAN FRANCISCO–(BUSINESS WIRE)–A new study published in the June issue of Mayo Clinic Proceedings suggests that patients who used Doctor On Demand’s video-based telemedicine visits appreciate their relationships with the physician and overall user experience, including access and convenience. Further, this study found that the majority of patients who interacted …

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Microsoft and Adaptive Launch ImmuneCODE Database to Share Populationwide Immune Response to COVID-19

SEATTLE and REDMOND, Wash., June 11, 2020 /PRNewswire/ — Adaptive Biotechnologies Corp. (Nasdaq: ADPT) on Thursday launched ImmuneCODE with Microsoft Corp. (Nasdaq: MSFT) to begin sharing one of the largest, most detailed views of the immune response to COVID-19 in real time based on de-identified data generated from thousands of …

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Illumina Receives First FDA Emergency Use Authorization for a Sequencing-Based COVID-19 Diagnostic Test

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) is paving the way for large-scale, next-generation sequencing-based (NGS) COVID-19 testing. Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Illumina COVIDSeq™ Test, a high-throughput, sequencing-based, in vitro diagnostic (IVD) workflow enabling the detection of SARS-CoV-2. The …

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Thermo Fisher Scientific to Co-Develop a Global Companion Diagnostic for Low-Grade Glioma with Agios Pharmaceuticals

CARLSBAD, Calif., June 9, 2020 /PRNewswire/ — Thermo Fisher Scientific today announced that it has expanded its strategic partnership with Agios Pharmaceuticals by adding the co-development of a second companion diagnostic (CDx) for oncology to their existing agreement. The CDx will leverage the Oncomine Precision Assay, which runs on the …

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FDA Grants Emergency Use Authorization to Roche’s Elecsys IL-6 Test to Identify Patients at High Risk of Severe Inflammatory Response

Basel, 04 June 2020  – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify …

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Siemens Healthineers Receives FDA Emergency Use Authorization for its SARS-CoV-2 Total Antibody Test that Delivers Superior Clinical Performance

TARRYTOWN, N.Y.–(BUSINESS WIRE)–Siemens Healthineers announced today the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies including IgM and IgG in blood. Test data demonstrated 100 percent sensitivity2 and 99.8 percent specificity. The total antibody …

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ArcherDX and AstraZeneca Collaborate to Develop Personalized Cancer Monitoring Assays for Minimal Residual Disease

BOULDER, Colo., May 26, 2020 /PRNewswire/ — ArcherDX, Inc., today announced a strategic collaboration with AstraZeneca to develop assays to support multiple planned Phase 3 clinical trials for AstraZeneca’s targeted immuno-oncology therapeutics. Under the terms of the agreement, ArcherDX will perform Whole Exome Sequencing (WES) of resected non-small cell lung …

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