AUSTIN, Texas, June 29, 2020 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that the company has submitted an Emergency Use Authorization request to the U.S. Food and Drug Administration (FDA) for its xMAP® SARS-CoV-2 Multi-Antigen IgG assay. The assay was developed to provide additional capacity to detect antibodies in patients who may have been exposed... Read more
Basel, 29 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Phesgo™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and... Read more
Initiative to enhance newborn screening in underserved populations for improved health outcomes in Africa WALTHAM, Mass. – June 18, 2020 – PerkinElmer, Inc. (NYSE:PKI), a global leader committed to innovating for a healthier world, today announced a collaboration with the American Society of Hematology (ASH), the world’s largest professional society of hematologists, to support a... Read more
Chalfont St Giles, UK – June 15 2020 GE Healthcare is working with the University of Oxford-led National Consortium of Intelligent Medical Imaging (NCIMI) in the UK to develop and test algorithms to aid in the diagnosis and management of COVID-19 pneumonia. The program will focus on developing, enhancing and testing potential algorithms to help... Read more
Company’s latest FDA EUA solution broadens RT-PCR and serology offerings available in the U.S. WALTHAM, Mass. – June 15, 2020 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today that EUROIMMUN, a PerkinElmer Company, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for... Read more
FDA Grants Breakthrough Device Designation to Thermo Fisher Scientific’s Oncomine Precision Assay to Identify IDH1 and IDH2 Mutations in Low-Grade Glioma Patients Designation follows recent announcement on development of first companion diagnostic using the Oncomine Precision Assay on the new Ion Torrent Genexus System CARLSBAD, Calif., June 15, 2020 /PRNewswire/ — The U.S. Food and Drug... Read more
SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) is paving the way for large-scale, next-generation sequencing-based (NGS) COVID-19 testing. Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Illumina COVIDSeq™ Test, a high-throughput, sequencing-based, in vitro diagnostic (IVD) workflow enabling the detection of SARS-CoV-2. The end-to-end workflow extends the options... Read more
Chicago, Illinois – June 9, 2020 – To help empower clinicians and patients in their fight against breast cancer, GE Healthcare today announced the Food and Drug Administration’s 510(k) clearance of Pristina Serena Bright™*, the healthcare industry’s first contrast-enhanced mammography solution for https://www.genewsroom.com/press-releases/ge-healthcare-receives-fda-clearance-industry%E2%80%99s-first-contrast-enhanced-mammography Read more
Thermo Fisher Extends NanoDrop One/OneC Spectrophotometer to FDA-Regulated Companies New software can be used by pharma, biotech labs to comply with Title 21 CFR Part 11 data integrity regulations HILLSBORO, Ore., June 8, 2020 /PRNewswire/ — Thermo Fisher Scientific today announced its Thermo Scientific NanoDrop PC Control software + Security Suite for NanoDrop One/OneC can be... Read more
FDA EUA1 now makes IL-6 testing accessible to patients in the United States to assist in identifying severe inflammatory response in patients with confirmed COVID-19 and is also available in markets accepting the CE-mark2 Interleukin 6 (IL-6) is an early indicator for acute inflammation to aid in the management of critically ill patients This test... Read more