Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year, and more than 620,000 people will die from the disease.1 About 15 to 20 percent of women diagnosed with breast cancer are HER2 positive.2 VENTANA HER2 Dual ISH DNA Probe Cocktail assay3 aids in identifying HER2-positive breast cancer patients eligible for the... Read more
FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat Thermo Fisher Scientific’s ImmunoCAP Specific IgE alpha-Gal Allergen Component test helps clinicians pinpoint a potentially fatal allergy often resulting from tick bites PORTAGE, Mich., July 23, 2020 /PRNewswire/ — ImmunoCAP Specific IgE alpha-Gal Allergen Component test has been cleared by the U.S.... Read more
AUSTIN, Texas, July 20, 2020 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the company’s xMAP® SARS-CoV-2 Multi-Antigen IgG Assay. Clinical laboratories can now use this serology assay to identify the presence of antibodies in people who have been infected with the... Read more
FRANKLIN LAKES, N.J., July 8, 2020 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the formation of a strategic, public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response,... Read more
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