In Vitro Diagnostics – IVD News

GAITHERSBURG, Md., March 30, 2020 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today that, following its Special Meeting of Shareholders held March 30, 2020, OpGen shareholders overwhelmingly voted to approve the proposed business combination with Curetis…

Holzgerlingen, Germany, March 16, 2020, 08:00 am CET – Curetis N.V. (the “Company” and together with its subsidiaries “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that it starts offering a CE-IVD certified real-time PCR test kit for SARS-CoV2 (also known as 2019-nCov), the causal pathogen of Corona Virus Disease 2019 (Covid-19). The…

Amsterdam, the Netherlands, Holzgerlingen, Germany, and San Diego, CA, USA, March 10, 2020, 14:15 pm CET – Curetis N.V. (the “Company” and together with its subsidiaries “Curetis”), a developer of next-level molecular diagnostic solutions, today reported the results of its Extraordinary General Meeting (the “EGM”) held in Schiphol today, March 10, 2020. Shareholders adopt all…

03 Mar 2020 – MedTech Insights – The US Centers for Medicare and Medicaid Services is considering a national coverage determination for a blood-based biomarker screening test for colorectal cancer after receiving a request for a national coverage determination from Epigenomics for its Epi proColon assay. The US Centers for Medicare and Medicaid Services on…

Berlin, 28.02.2020– Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the Centers for Medicare & Medicaid Services (CMS) have opened the National Coverage Determination (NCD) review of Epi proColon, Epigenomics’ blood test for colorectal cancer screening. This means that according to the statutes, a decision on CMS’s reimbursement of Epi proColon…

Vienna, Austria, Holzgerlingen, Germany, and Shenzhen, China, January 30, 2020, 08:00 am CET – Ares Genetics GmbH, a Curetis Group company, and the Chinese genomics company BGI Group today announced that the companies will collaborate in making molecular testing for the new coronavirus 2019-nCoV available in Europe. 2019-nCoV is a new coronavirus variant that has…

Amsterdam, the Netherlands, Holzgerlingen, Germany, and San Diego, CA, USA, January 14, 2020, 08:00 am CET — Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced the U.S. launch of its Unyvero LRT BAL Lower Respiratory Tract Application Cartridge for use with bronchoalveolar lavage (BAL)…

Amsterdam, the Netherlands, Holzgerlingen, Germany, and San Diego, CA, USA, December 20, 2019, 23:30 CET — Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that the Company has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market its Unyvero LRT…

Vienna, Austria, and Holzgerlingen, Germany, December 10, 2019, 08:00 am CET – Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that its fully-owned subsidiary Ares Genetics has joined the NVIDIA Inception program as a community member. The Inception program is designed to nurture start-ups…

BERLIN, Dec. 02, 2019 (GLOBE NEWSWIRE) — Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), today reported on micro-simulation model results indicating that Epi proColon®, a colorectal cancer (CRC) screening test approved for patients who are unwilling or unable to be screened by the United States Preventive Services Task Force (USPSTF) recommended methods, provides clinically…