December 28, 2020 Clinical Research/Diagn. Licensing, IP, and Legal

Quanterix Receives FDA Emergency Use Authorization for Semi-quantitative Antibody Test

Infectious Disease Technology Antibody test available on Simoa HD-X Analyzer® detects and quantitates IgG antibodies to SARS-CoV-2 in serum or EDTA plasma   BILLERICA, Mass., December 28, 2020 – Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced that the Food and Drug Administration (FDA) has issued an Emergency Use... Read more

December 14, 2020 Acad, Gov/Utilities Licensing, IP, and Legal

FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis

Basel, 14 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The... Read more

December 8, 2020 Clinical Research/Diagn. Licensing, IP, and Legal

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

December 8, 2020 Clinical Research/Diagn. Licensing, IP, and Legal

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

November 30, 2020 Clinical Research/Diagn. Licensing, IP, and Legal Life Science Tools

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

November 24, 2020 Clinical Research/Diagn. Licensing, IP, and Legal Life Science Tools

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

November 23, 2020 Clinical Research/Diagn. Licensing, IP, and Legal Life Science Tools

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

November 16, 2020 Licensing, IP, and Legal Liq. Handling & Robotics Product Launch

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