GBC Blog

Federal Policy for the Protection of Human Subjects – Updated “Common Rule”

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published…

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How a New Test Could Solve a Costly Problem

A molecular diagnostics company wants to expand its new cartridge-based platform to help orthopedic surgeons make more informed care decisions for patients with a potential joint infection. Curetis is currently expecting an FDA decision on its new cartridge-based diagnostic platform, the Unyvero system, for lower respiratory infections. The company is also collecting samples to pursue…

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Liquid Biopsy Test Shows Promise for Detecting Early-Stage Colorectal Cancer

“Screening for colorectal cancer can be life-saving, but Americans still lag behind Federal government screening goals because current screening options can be inconvenient and uncomfortable for patients. Though this research needs more investigation, a simple, accurate blood test could help increase screening rates, which could ultimately improve detection of colorectal cancers at earlier stages when…

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2020 is the New Hottest Date in Genomics

Year 2020 has been set as the delivery date for 500,000 whole exome sequences from the UK Biobank cohorts. A consortium of six drug companies will turn UK Biobank into the world’s single biggest concentration of genetic and health data anywhere, giving scientists and drug companies a powerful tool for understanding diseases. Biobank is a…

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Curetis and MGI Advance Strategic Partnership in NGS-Based Molecular Microbiology

– Inked new collaboration and commercialization deals with MGI to leverage Curetis´ sample preparation technology – Enabling short-term commercialization of NGS-based molecular microbiology Amsterdam, the Netherlands, and Holzgerlingen, Germany, January 10, 2018; published at 01:00 am EST — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions,…

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Dr. Robert W. Day – Fed Hutchinson Director and Epigenomics CMO

Originally published January 7, 2018 at 5:43 pm Dr. Robert Day, former director of the Fred Hutchinson Cancer Center who brought the campus to South Lake Union, has died at home. Dr. Robert Day, who led the Fred Hutchinson Cancer Center for 16 years and spent much of his retirement working on public-health issues, died…

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Key Tips for Diagnostics in 2018 and Beyond: Development Success in the Evolving US and EU Landscape

TORONTO, ON–(Marketwired – November 29, 2017) – In an upcoming webinar hosted by Xtalks on Thursday, December 14, 2017, leading diagnostics specialty CRO Health Decisions will introduce guest speakers Gail Radcliffe, Ph.D., President of Radcliffe Consulting Inc. and a member of the Health Decisions Scientific Advisory Board, and Jessica Kappes, MBA, MT, CCRA, Health Decisions Project…

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Epigenomics AG Announces Recent Payment Decision by CMS

21. NOVEMBER 2017.   Berlin (Germany) and Germantown, MD (U.S.A.), November 21, 2017 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) announced the Centers of Medicare & Medicaid Services(CMS) has changed their pricing determination for Epi proColon®, the first and only FDA-approved blood-based test for colorectal cancer (CRC) screening. In its recently published final payment…

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Epigenomics Initiates €5.5M Private Placement

Epigenomics Initiates €5.5M Private Placement Sep 21, 2017, NEW YORK (GenomeWeb) – Epigenomics said today that it plans to raise approximately €5.5 million ($6.5 million) in a private share placement. The Berlin-based molecular diagnostic firm said that it will increase its share capital in the amount of €1.28 by issuing approximately 1.28 million new registered shares…

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BioreclamationIVT Acquires Biospecimen and Research Services Provider Asterand Bioscience

BioreclamationIVT has acquired Asterand Bioscience™, a global provider of human tissue and research solutions with a focus on the oncology market. Asterand Bioscience advances drug research by accelerating target identification and biomarker validation, and improving drug candidate selection to increase the likelihood of clinical success. “We are delighted that Asterand Bioscience’s talented staff is joining…

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