September 14, 2020 Clinical Research/Diagn. Lab Top-10 M&A, Partnerships

Thermo Fisher Scientific Announces Collaborations to Meet Unmet Clinical Needs in Biomarker Discovery and Characterization

Thermo Fisher Scientific Announces Collaborations to Meet Unmet Clinical Needs in Biomarker Discovery and Characterization Agreements with AstraZeneca and the University of Nebraska Medical Center showcase new workflows to improve the throughput, robustness and standardization of clinical biomarker analysis CAMBRIDGE, Mass., Sept. 14, 2020 /PRNewswire/ — Thermo Fisher Scientific, the world leader in serving science,... Read more

September 9, 2020 Clinical Research/Diagn. Licensing, IP, and Legal

Roche expands its multiple sclerosis portfolio with investigational BTK inhibitor fenebrutinib and initiates novel clinical trials for OCREVUS (ocrelizumab)

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS) Phase IIIb clinical trial programme of higher-dose OCREVUS (ocrelizumab) to evaluate impact on reducing disability progression in RMS and PPMS OCREVUS CHIMES... Read more

September 8, 2020 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10 Life Science Tools

FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer

FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for GAVRETO CARLSBAD, Calif., Sept. 8, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a... Read more

August 25, 2020 Clinical Research/Diagn. Licensing, IP, and Legal Life Science Tools

Fluidigm Granted FDA Emergency Use Authorization for Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay for COVID-19

Easy-to-Administer Saliva Test for COVID-19 Available for Immediate Shipment Extraction-Free, Real-Time PCR Workflow with Capacity of up to 6,000 Tests per Day per System Demonstrated 100 Percent Agreement with Authorized Nasopharyngeal Assays SOUTH SAN FRANCISCO, Calif., Aug. 25, 2020 (GLOBE NEWSWIRE) — Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight,... Read more

August 19, 2020 Clinical Research/Diagn. Licensing, IP, and Legal Life Science Tools

Zymo Research Granted CE IVD Mark for Quick SARS-CoV-2 rRT-PCR Kit

IRVINE, Calif., (Aug. 19, 2020) — Zymo Research announced that it was recently granted the CE IVD Mark for its Quick SARS-CoV-2 rRT-PCR Kit. To obtain this certification the product had to comply with the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. The Quick SARS-CoV-2 rRT-PCR Kit is... Read more

August 19, 2020 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10 Microscopy

Thermo Fisher Scientific Introduces Hematology-Oncology Portfolio for Ion Torrent Genexus System*

Thermo Fisher Scientific Introduces Hematology-Oncology Portfolio for Ion Torrent Genexus System* CARLSBAD, Calif., Aug. 19, 2020 /PRNewswire/ — In hematology oncology, it is critically important to understand the genetics driving acute malignancies to quickly determine how best to address the disease. Today, Thermo Fisher Scientific announces a new portfolio of hematology-oncology assays for the Ion... Read more

August 17, 2020 Clinical Research/Diagn. Lab Top-10 M&A, Partnerships

Thermo Fisher Scientific Signs Companion Diagnostic Agreement with Hengrui Therapeutics, Inc.

Thermo Fisher Scientific Signs Companion Diagnostic Agreement with Hengrui Therapeutics, Inc. Companion diagnostic will leverage the Oncomine Precision Assay to identify non-small cell lung cancer patients who may benefit from pyrotinib CARLSBAD, Calif., Aug. 17, 2020 /PRNewswire/ — Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Hengrui Therapeutics, Inc. (HTI), a U.S. subsidiary... Read more

August 11, 2020 Clinical Research/Diagn. Life Science Tools Product Launch

Bio-Techne Announces Release of a New SARS-CoV-1/2 Spike RBD Llamabody Recombinant Antibody That Blocks Viral Entry

MINNEAPOLIS, Aug. 11, 2020 /PRNewswire/ — Bio-Techne Corporation (NASDAQ:TECH) today announced the release of the SARS-CoV-1/2 Spike RBD LlaMABody Recombinant Antibody, which binds to the SARS-CoV-2 spike receptor binding domain (RBD) and blocks the virus from binding to its host receptor, ACE-2, inhibiting viral infection . The SARS-CoV-1/2 Spike RBD LlaMABody Recombinant Antibody is the... Read more

August 11, 2020 Clinical Research/Diagn. Product Launch

Promega Launches COVID-19 Serology Test: Lumit™ Dx SARS-CoV-2 Immunoassay Workflow is Quick, Simple and Scalable for High-Throughput Antibody Detection

Madison, WI USA. (August 11, 2020) Promega Corporation today announced the launch of its new serological antibody test for COVID-19 to detect the presence of antibodies against the SARS-CoV-2 virus. A positive result may indicate whether an individual has been exposed to, and mounted an immune response to, the virus. Promega has submitted an application to the US... Read more

August 10, 2020 Atomic Spectroscopy Clinical Research/Diagn. Product Launch

Brain Gain: Stunning new MRI tech advances neuro research and clinical translation capabilities at #ISMRM20

Waukesha, WI – August 10, 2020 – At this year’s virtual ISMRM meeting, GE Healthcare is showcasing new technologies to enable neuro research to better understand Alzheimer’s disease and traumatic brain injury, as well as accelerate clinical translation. The 510(k)-pending SIGNA 7.0T [1], as well as research devices SIGNA ultra-high performance (UHP) 3.0T and the... Read more