QIAGEN receives FDA approval to expand use of EGFR test in lung cancer

Germantown, Maryland, and Hilden, Germany, January 18, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN’s therascreen® EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer Ingelheim’s... Read more

QIAGEN receives FDA clearance for first-ever JAK2 test for use in diagnosis of additional myeloproliferative neoplasms

Hilden, Germany, and Germantown, Maryland, January 23, 2018 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it has received clearance for its ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) from the U.S. Food and Drug Administration (FDA) for additional use in the diagnosis of all myeloproliferative neoplasms (MPNs), which are a... Read more

BD Statement on FDA Warning Letter for Preanalytical Systems Business Unit

FRANKLIN LAKES, N.J., Jan. 12, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX) issued the following statement in response to receiving a warning letter from the U.S. Food and Drug Administration for its Preanalytical Systems business unit. Richard Byrd, worldwide president of BD Preanalytical Systems said: “Ensuring the safety and quality of our products... Read more

Illumina and KingMed Diagnostics Partner to Develop Next-Generation Sequencing Technology for Chinese FDA Approval

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) and KingMed Diagnostics (SSE: 603882.SS) today announced an agreement to jointly develop novel oncology and hereditary disease testing applications utilizing Illumina’s next-generation sequencing (NGS) technology. The collaboration is a significant step toward China Food and Drug Administration (CFDA) review and approval, and serves as a starting point to deliver... Read more

FDA approves Roche’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer

Basel, 21 December 2017 FDA approves Roche’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer Accelerated approval of Perjeta for neoadjuvant use also converted to full approval Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) has approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab)... Read more

FDA approves Roche’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer

Basel, 21 December 2017 FDA approves Roche’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer Accelerated approval of Perjeta for neoadjuvant use also converted to full approval Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) has approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab)... Read more

New Myeloid Research Assay Combines Simultaneous DNA and RNA Analysis of Most Relevant Hematologic Cancer Driver Genes

New Myeloid Research Assay Combines Simultaneous DNA and RNA Analysis of Most Relevant Hematologic Cancer Driver Genes Oncomine Myeloid Research Assay leverages Thermo Fisher’s next-generation sequencing to analyze 74 genes in a single panel and overcome hurdles of sequential-based clinical research CARLSBAD, Calif., Dec. 7, 2017 /PRNewswire/ — Clinical researchers interested in studying driver mutations suspected... Read more

Free Webinar On-Demand: New Cleanliness Workflow from Leica and Pall

Obtaining cleanliness results rapidly, accurately, and reliably is a significant advantage for manufacturers and component suppliers. For this reason, Pall Corporation and Leica Microsystems have joined efforts to offer a new, unique workflow solution customizable to your individual needs. Join our free webinar to get a sneak preview on Leica Microsystems’ new fully implemented LIBS... Read more

Watch the Webinar On-Demand: New Cleanliness Workflow from Leica and Pall

Classical polarized light (compound) microscopes can only be used for prepared samples, because the working distance they offer is insufficient for whole samples. This means that thicker and bigger geological samples have to be sectioned and polished to fit under the limited working distance of a compound microscope. The Leica DVM 6 provides outstanding image... Read more