April 12, 2019 Acad, Gov/Utilities Clinical Research/Diagn. Product Launch

QIAGEN launches first FDA-approved companion diagnostic using FGFR alterations to help guide the treatment of metastatic urothelial cancer

Germantown, Maryland, and Hilden, Germany, April 12 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of its novel therascreen® FGFR RGQ RT-PCR Kit (therascreen FGFR Kit) as a companion diagnostic to help guide the use of the newly approved FGFR kinase inhibitor, BALVERSA™ (erdafitinib), developed by Janssen Biotech,... Read more

April 11, 2019 Clinical Research/Diagn.

QIAGEN’s QuantiFERON®-TB passes milestone of 60 million tests in global fight against tuberculosis, current annual run rate exceeds 12 million tests

Hilden, Germany; Germantown, Maryland; and Amsterdam, Netherlands, April 11, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its modern gold standard QuantiFERON®-TB test for detection of latent tuberculosis (TB) infections has surpassed 60 million tests administered, having impacted the lives of millions of patients worldwide and supporting the global fight... Read more

April 11, 2019 Clinical Research/Diagn. Life Science Tools M&A, Partnerships Product Launch

QIAGEN and NeuMoDx expand assay menu for their next generation of fully integrated PCR systems for clinical laboratories in Europe and also announce availability of NeuMoDx 96 version

Hilden, Germany, and Ann Arbor, Michigan, April 11, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and NeuMoDx Molecular, Inc. today announced an expansion of the content menu for the NeuMoDx™ 96 and 288 Molecular Systems, as well as the commercial availability of the NeuMoDx 96 mid-throughput version of this family of fully... Read more

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