January 7, 2019 Clinical Research/Diagn. M&A, Partnerships

QIAGEN acquires N-of-One, expanding its clinical bioinformatics capabilities in molecular oncology decision support

Redwood City, California, and Hilden, Germany, January 7, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today it has entered into an agreement to acquire N-of-One, Inc., a privately-held U.S. molecular decision support company and pioneer in clinical interpretation services for complex genomic data. The addition of N-of-One will enable QIAGEN to... Read more

December 19, 2018 Clinical Research/Diagn.

United Kingdom’s National Institute for Health and Care Excellence (NICE) Recommends NanoString’s Prosigna Breast Cancer Gene Signature Assay to Guide Chemotherapy Treatment Decisions for Qualified Early-Stage Invasive Breast Cancer Patients

PDF Version SEATTLE, Dec. 19, 2018 (GLOBE NEWSWIRE) — NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that health officials from the National Institute for Health and Care Excellence (NICE) in the United Kingdom recently issued a recommendation that includes the use of the Prosigna® Breast Cancer Gene Signature Assay result to... Read more

December 19, 2018 Clinical Research/Diagn. Licensing, IP, and Legal

bioMérieux receives FDA clearance for BPA and BPN culture bottles used with BACT/ALERT® VIRTUO® for quality control testing of platelets

19 December, 2018 bioMérieux, a world leader in the field of in vitro diagnostics, announces that its culture bottles BACT/ALERT® BPA and BPN have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for quality control testing of leukocyte-reduced apheresis platelet (LRAP) units with the BACT/ALERT® VIRTUO® fully automated blood culture system. This innovative FDA cleared and CE marked... Read more

December 17, 2018 Clinical Research/Diagn. M&A, Partnerships

Arrayit Corporation Fulfills Clinical Instrumentation Contract with the United States Food and Drug Administration

By GlobeNewswire, December 31, 2018, 05:30:00 AM EDT: Source Arrayit Corporation By GlobeNewswire, December 17, 2018, 05:30:00 AM EDT: Source Arrayit Corporation Sunnyvale, Dec. 17, 2018 (GLOBE NEWSWIRE) — Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, reports fulfillment of a clinical instrumentation contract with the United States Food and Drug Administration (FDA),... Read more

December 13, 2018 Cell Analysis Tools Clinical Research/Diagn. Life Science Tools

Crown Bioscience Creates Center of Excellence for Bioinformatics, Big Data, and Biomarker Discovery Services

December 18, 2018 ~ Services and Capacity Increase with New Site Opening ~ (San Diego, Calif., December 13, 2018) — Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, has recently announced the expansion of its existing translational oncology research capacity by opening... Read more

December 11, 2018 Clinical Research/Diagn.

BD Announces Completion Of Enterprise Level Cybersecurity Assessment From UL

BD FACSLyric™ Flow Cytometer is First BD Product to Earn UL Cybersecurity Assurance Program Certification FRANKLIN LAKES, N.J., Dec. 11, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the completion of an enterprise level cybersecurity assessment from UL. This independent assessment evaluates corporate cybersecurity programs and policies to... Read more

December 10, 2018 Clinical Research/Diagn. Lab Top-10 Product Launch

Thermo Fisher Scientific Launches Complementary Diagnostic Immunoassay Measuring Plazomicin Concentrations

Thermo Fisher Scientific Launches Complementary Diagnostic Immunoassay Measuring Plazomicin Concentrations FREMONT, Calif., Dec. 10, 2018 /PRNewswire/ — Thermo Fisher Scientific has received FDA clearance for its de novo submission of the Thermo Scientific QMS Plazomicin Immunoassay, the first of its kind for complementary diagnostic immunoassays. This quantitative immunoassay measures the concentration of a novel therapeutic... Read more

December 6, 2018 Clinical Research/Diagn. M&A, Partnerships

QIAGEN (Suzhou) and Abcam sign strategic MoU collaboration agreement to co-develop companion diagnostic (CDx) and in vitro diagnostic (IVD) reagents and kits for the Chinese market

Suzhou, China and Cambridge, UK, December 6: Abcam plc, a global innovator in life science reagents and tools, and QIAGEN (Suzhou) Translational Medicine Co., Ltd. (QIAGEN (Suzhou)) have signed a Memorandum of Understanding (MoU) agreement to jointly develop a pipeline of Companion Diagnostic (CDx) and In Vitro Diagnostic reagents and kits, to meet the specific needs... Read more

December 6, 2018 Cell Analysis Tools Clinical Research/Diagn. Product Launch

The Native Antigen Company launches new Zika immunoassays with unprecedented specificity and sensitivity

29 November 2018, Oxford, UK – The Native Antigen Company has launched a series of ground-breaking immunoassays for Zika virus, offering researchers in academia, public health and drug discovery the capability to work with unprecedented levels of specificity and sensitivity. Unlike previous methods, the new assays have little or no cross-reactivity with other flaviviruses, including... Read more

December 6, 2018 Clinical Research/Diagn. M&A, Partnerships Product Launch

QIAGEN announces new collaboration to develop companion diagnostic to guide treatment for patients with PIK3CA-mutated advanced breast cancer

Germantown, Maryland, and Hilden, Germany, December 6, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that a clinical development program is underway with Novartis to bring to market a molecular test as a companion diagnostic to guide the use of the investigational compound BYL719 (alpelisib) in combination with fulvestrant for men... Read more