News

Curetis and OpGen Enter Into Definitive Agreement to Combine Businesses

Gaithersburg, MD, USA, Amsterdam, the Netherlands, and Holzgerlingen, Germany, 04 September 2019, 0800 am CET, 0655 am ET  – OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, and Curetis N.V. (Euronext: CURE, “Curetis”), a developer of next-level molecular diagnostic solutions, today…

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Curetis Files for U.S. FDA 510(k) Clearance of Unyvero Lower Respiratory Tract (LRT) Infection Assay for Bronchoalveolar Lavage (BAL) Specimens

Curetis Files for U.S. FDA 510(k) Clearance of Unyvero LRT for BAL Specimens Final LRT BAL panel demonstrates overall weighted average sensitivity of up to 94.7% and overall weighted average specificity of up to 98.4% Unyvero provides results after approximately five hours, compared to an average of several days for standard-of-care methods Amsterdam, the Netherlands,…

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Epigenomics AG Receives MedTech Outlook’s 2019 Top 10 In-Vitro Diagnostics Award

BERLIN and SAN DIEGO, (GLOBE NEWSWIRE) — Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) announced today that it was selected by MedTech Outlook to receive the 2019 Top 10 In-Vitro Diagnostics Award. Conducted annually, the award recognizes companies that are excelling in their respective fields. The selection panel noted that through its unique, proprietary DNA methylation…

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New Clinical Data Support the Utility of Epi proColon Blood Test for Colorectal Cancer (CRC) Screening in Patients with Lynch Syndrome (LS), the Most Common Hereditary CRC Syndrome

Berlin (Germany), June 17, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new study results suggesting that Epi proColon, a colorectal cancer screening test approved for patients who are unwilling or unable to be…

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New Data on Curetis Unyvero LRT Panel for Pneumonia to be Presented at ASM Microbe 2019

Amsterdam, the Netherlands, San Diego, CA, USA, and Holzgerlingen, Germany, June 04, 2019 – Curetis N.V. (the “Company” and, together with Curetis GmbH and Curetis USA Inc. “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that new data on its Unyvero System and LRT Application Cartridge for pneumonia will be presented at the…

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Curetis Reports Positive Results from Clinical Validation Study for U.S. FDA 510(k) Submission of Unyvero LRT for BAL Samples

Amsterdam, the Netherlands, and Holzgerlingen, Germany, May 23, 2019 — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced key data from its successfully completed Unyvero LRT clinical performance evaluation study for BAL samples. The study was designed based on U.S. FDA feedback to demonstrate enhanced…

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New Report Shows CRC Screening Rates Increased When a Medically Underserved Population is Offered Epi proColon Blood Test

Berlin (Germany) and San Diego, CA (U.S.A.), May 20, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new results that underscore Epi proColon(R) colorectal cancer’s (CRC) high acceptance rate compared with stool-based screening tests…

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Vela Diagnostics Submits NGS HIV Genotyping, Drug Resistance Assay to FDA

NEW YORK (GenomeWeb) Mar 26, 2019 – Vela Diagnostics has submitted a next-generation sequencing (NGS) assay that detects HIV-1 drug resistance mutations (DRMs) to the US Food and Drug Administration (FDA), the company announced today. The Sentosa SQ HIV Genotyping Assay can be used on plasma samples from patients with HIV-1 infection to detect HIV-1…

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Curetis and Menarini Diagnostics Enter into Strategic Pan-European Exclusive Partnership for the Distribution of Curetis’ Unyvero

Menarini Diagnostics to distribute Unyvero Platform and application cartridges in numerous European countries Menarini Diagnostics to deploy its commercial team for the marketing of Unyvero Platform across Europe Partnership to be launched at ECCMID 2019 in Amsterdam Amsterdam, the Netherlands, and Holzgerlingen, Germany, March 26, 2019, 08:00 am CET – Curetis N.V. (the “Company” and,…

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