Thermo Fisher Scientific Gains CE Mark Certification for New OmniPATH Combi SARS-CoV-2 IgG ELISA Test
Quantifying IgG is critical component to test population-wide vaccination effectiveness Read more
Category: Licensing, IP, and Legal
Matters of legal in nature including licensing, intellectual property, and lawsuits.
Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay
December 8, 2020 at 10:17 AM EST CINCINNATI, Dec. 08, 2020 (GLOBE NEWSWIRE) — Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced that it has submitted its application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the company’s SARS-CoV-2 molecular diagnostic test on the Revogene® platform. The... Read more
LGC’s Anti-SARS-CoV-2 controls kit now CE Marked
LGC is pleased to announce that the ACCURUN® Anti-SARS-CoV-2 Reference Material Kit is now CE marked for in vitro diagnostic use (CE-IVD). With this change in regulatory status, the new product name is ACCURUN Anti-SARS-CoV-2 Controls Kit. Bearing the CE mark and IVD symbol signifies that the ACCURUN Anti-SARS-CoV-2 Controls Kit meets extensive design control requirements. ACCURUN... Read more
LGC’s high-throughput PCR testing system for SARS-CoV-2 detection, submitted for Emergency Use Authorisation, capable of processing up to 35,000 tests per day
LGC’s high-throughput (HTP) RT-PCR testing system for SARS-CoV-2 has been submitted to the FDA for Emergency Use Authorisation (EUA). Testing labs can now leverage LGC’s unrivalled expertise in automated sample preparation and high-throughput RT-PCR workflows in a ready-to-deploy solution. As the need for SARS-CoV-2 testing for both diagnostic and screening applications continues to grow, many organisations are... Read more
Key Regulatory Body in India Grants Commercial License for Fluidigm Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay
Nov 24, 2020 Fluidigm Assay is Among First Saliva-Based COVID-19 Tests Licensed for Use by Designated Labs in India SOUTH SAN FRANCISCO, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) — Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that the Central Drugs Standard Control Organisation (CDSCO) in India has licensed importation and... Read more
Zymo Research Receives CE IVD Mark for Its Quick-DNA/RNA Viral MagBead Kit
RELIABLE AND SENSITIVE VIRAL PURIFICATION USED FOR SARS-COV-2 VIRAL DETECTION AND ANALYSIS Zymo Research’s Quick-DNA/RNA Viral MagBead Kit has been cleared for in vitro diagnostic applications for use by EU member states. IRVINE, Calif., (Nov. 23, 2020) — Zymo Research announced today that its Quick-DNA/RNA Viral MagBead Kit was cleared for distribution to the European Union (EU) common market.... Read more
QIAGEN launches NeuMoDx multiplex test to complete range of SARS-CoV-2 testing solutions in Europe and other markets
Germantown, Maryland, and Hilden, Germany, November 16, 2020 –QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the European launch of the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test that will help healthcare professionals quickly identify and differentiate between patients with common seasonal respiratory infections and COVID-19. With the Northern Hemisphere in the grip of flu... Read more
Brooks to Participate in the Stephens Annual Investment Virtual Conference 2020
CHELMSFORD, Mass., Nov. 16, 2020 /PRNewswire/ — Brooks Automation, Inc. (Nasdaq: BRKS) announced today that company management will participate in Stephens Annual Investment Conference 2020 on Thursday, November 19, 2020 which includes a 45-minute webcast beginning at 9:00 a.m. ET. The live webcast can be accessed through the Brooks investor relations website at www.brooks.investorroom.com/events. A replay... Read more