April 11, 2019 Clinical Research/Diagn. Product Launch

QIAGEN highlights profile of new QIAstat-Dx Meningitis / Encephalitis panel focused on most prevalent central nervous system pathogens

Hilden, Germany, and Amsterdam, Netherlands, April 11, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced new data of the QIAstat-Dx Meningitis / Encephalitis panel. The panel is in late stage development and being prepared for CE-IVD commercialization in the second half of 2019 for use on the QIAstat-Dx multiplex syndromic testing... Read more

April 8, 2019 Clinical Research/Diagn. Licensing, IP, and Legal

Bio-Rad Receives U.S. FDA Clearance for the IH-500, Expanding Its Offering for the Blood Testing Market

Date: 04/08/2019 HERCULES, Calif.–Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Bio-Rad’s IH-500, an automated random access system for blood typing and screening. The IH-500 system was designed for small-... Read more

April 3, 2019 Clinical Research/Diagn. M&A, Partnerships

QIAGEN and LabCorp launch collaboration to provide Day-One access for patients to innovative companion diagnostics at the time of drug approvals

Hilden, Germany, and Germantown, Maryland, April 03, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a master service agreement with LabCorp® (NYSE: LH) to further accelerate the access of cancer patients to QIAGEN’s companion diagnostic products following regulatory approvals of drugs and their associated tests. As a new participant in QIAGEN’s... Read more

April 3, 2019 Atomic Spectroscopy Clinical Research/Diagn. M&A, Partnerships

Roche and Spark Therapeutics, Inc. announce withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer for shares of Spark Therapeutics, Inc.

Basel, 03 April 2019 Roche and Spark Therapeutics, Inc. announce withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer for shares of Spark Therapeutics, Inc. Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced that Roche has withdrawn its Premerger... Read more

April 2, 2019 Clinical Research/Diagn. Licensing, IP, and Legal Product Launch

Bio-Rad Announces Innovative Test to Aid in the Diagnosis of Lyme Disease with the FDA Clearance of the BioPlex 2200 Lyme Total Assay

Date: 04/02/2019 HERCULES, Calif.–Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its BioPlex 2200 Lyme Total Assay, an innovative multiplex test method to aid in the diagnosis of Lyme disease. Lyme... Read more

April 2, 2019 Clinical Research/Diagn. Lab Top-10 M&A, Partnerships

NanoString and Leica Biosystems to Co-Market GeoMx Digital Spatial Profiling and Leica’s BOND RX Platforms for High Throughput Spatial Analysis

Combined Workflow Provides Complete Solution for Rapid, Automated, and Highly Multiplexed Profiling of Protein and RNA Biomarkers in FFPE Samples SEATTLE and NEWCASTLE UPON TYNE, UK, April 02, 2019 (GLOBE NEWSWIRE) — NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced a comarketing agreement to promote and provide technical support for... Read more

April 2, 2019 Clinical Research/Diagn. Lab Top-10

PerkinElmer Genomics Introduces Physician-Ordered Genetic Screening Test for Proactive Health Management

Available in Helix’s DNA marketplace, GenePrism: Actionable Insights is the first clinical-grade DNA test available to health individuals that analyzes all 59 medically actionable genes identified by the American College of Medical Genetics and Genomics WALTHAM, Massachusetts – April 2, 2019 – Today, in collaboration with Helix, PerkinElmer, Inc., a global leader committed to innovating... Read more

April 1, 2019 Clinical Research/Diagn. Environ, Ag./Food & Bev Lab Top-10

New Expanded Analytical Instrument Portfolio of U.S. FDA Class I Medical Devices for Clinical Diagnostic Laboratories

Palm Springs, CA – MSACL US 2019 – (April 1, 2019)– Thermo Fisher Scientific announces the expansion of its portfolio of analytical instruments for clinical diagnostic laboratories with the addition of three systems now listed as Class I medical devices with the United States Food and Drug Administration (U.S. FDA). The portfolio now offers clinical diagnostic laboratories... Read more

April 1, 2019 Clinical Research/Diagn. M&A, Partnerships

NanoString and Abcam Enter Commercial Partnership to Provide Expanded Menu of Antibodies for GeoMx Digital Spatial Profiler

— Abcam to Develop Conjugated FFPE IHC Validated Antibodies Compatible with the GeoMx DSP — SEATTLE and CAMBRIDGE, UK, April 01, 2019 (GLOBE NEWSWIRE) — NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced a commercial agreement with Abcam plc (AIM:ABC), a global innovator in life science reagents and tools, for the manufacture... Read more