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

December 3, 2020 Clinical Research/Diagn. Life Science Tools Product Launch

Meridian Launches its Novel Air-Dryable RT-qPCR Mix, Further Decreases Costs and Simplifies Workflows for COVID-19 Molecular Test Manufacturers

December 3, 2020 at 10:00 AM EST CINCINNATI, Dec. 03, 2020 (GLOBE NEWSWIRE) — Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced today that it has launched an Air-Dryable RT-qPCR Mix, driving innovation in the development of molecular tests with ambient temperature stability. This specialized master mix is designed... Read more

December 2, 2020 Clinical Research/Diagn. M&A, Partnerships

Regulus Therapeutics Collaborates with Bio-Techne for Biomarker Development

MINNEAPOLIS, Dec. 2, 2020 /PRNewswire/ — Bio-Techne Corporation (NASDAQ: TECH) and Regulus Therapeutics (NASDAQ: RGLS) announced a collaboration to support Regulus with biomarker analysis for the clinical development of RGLS4326, an Autosomal Dominant Polycystic Kidney Disease (ADPKD) treatment. Regulus has utilized two Bio-Techne branded product lines, ProteinSimple and Exosome Diagnostics, to aid in their clinical trial... Read more

December 1, 2020 Cell Analysis Tools Clinical Research/Diagn. Product Launch

Miltenyi Biotec launches all-in-one kits for stimulation and analysis of SARS-CoV-2–reactive T cells

T cell activation an important parameter in COVID-19; linked to execution and control of multiple mediators in controlling infections1, 2 BERGISCH GLADBACH, December 1st – Miltenyi Biotec today launches new all-in-one kits for the efficient stimulation and functional analysis of SARS-CoV-2‒reactive T cells. Specifically developed for fast and rapid detection in PBMC samples after stimulation with the SARS-CoV-2... 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 30, 2020 Clinical Research/Diagn. Lab Top-10

Charnwood Lighthouse Lab Goes Live Processing Thousands of COVID-19 Tests per Day with PerkinElmer Solutions

UK’s newest Lighthouse Lab boosts the country’s COVID-19 testing capacity, while generating hundreds of new local jobs   WALTHAM, Mass. – November 30, 2020 – PerkinElmer, Inc., announced today the Lighthouse Lab in Charnwood, Loughborough, England is now processing COVID-19 testing samples as part of the Company’s collaboration with the Department of Health and Social... 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 18, 2020 Atomic Spectroscopy Clinical Research/Diagn. M&A, Partnerships

QIAGEN collaborates with BioNTech on companion diagnostics development for HPV-associated squamous cell carcinoma of the head and neck

Hilden, Germany and Germantown, Maryland, November 18, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a strategic collaboration with BioNTech SE (Nasdaq: BNTX) to develop and commercialize a tissue-based companion diagnostic – to be used with investigational cancer treatment BNT113 – which identifies patients with squamous cell carcinoma of the head... Read more