August 06, 2020 - Roche (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) has authorized the cobas EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the U.S., the company claims. The authorization gives healthcare professionals the ability to run a large number of patient tests for the … [Read more...]
BD announces $24M U.S. government investment to support scale up of U.S. manufacturing of COVID-19 diagnostic tests
July 31, 2020 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) announced a $24 million investment from the U.S. Department of Defense (DOD) in collaboration with the U.S. Department of Health and Human Services (HHS) to support the scale up of U.S. manufacturing capabilities for BD Veritor Solution for Rapid Detection of SARS-CoV-2 (the virus that causes … [Read more...]
Sysmex launches lab assay service for research on cytokines related to COVID-19
July 27, 2020 - Sysmex Corporation (Kobe, Japan) announced its plans to continue conducting research and development (R&D) with the goal of expanding target parameters for lab assays and providing reagents for research.In preparation for a predicted resurgence of COVID-19, an urgent need exists for efforts to establish diagnostic tests that cover the time period spanning … [Read more...]
Hologic awarded $7.6M federal contract for COVID-19 testing
July 27, 2020 - Hologic Inc. was awarded an undefinitized contract action with a ceiling of $7.6 million from U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DOD) to expand production of custom sample collection and processing consumables for COVID-19 testing. This investment will increase Hologic's production from 4.8 million COVID-19 … [Read more...]
Thermo Fisher receives FDA approval for blood test for identifying novel allergic sensitization to red meat
July 23, 2020 - Thermo Fisher Scientific (Boston, MA) announced that the ImmunoCAP Specific IgE alpha-Gal Allergen Component test was cleared by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use. The company says that the test results can aid specialists and other healthcare providers as they diagnose a patient's sensitization to the alpha-Gal … [Read more...]
BD receives FDA approval for HPV test with extended genotyping capabilities
July 22, 2020 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) received approval for a pre-market approval (PMA) supplement from the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity HPV Assay. The PMA supplement includes the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, … [Read more...]
Henry Ford hospitals accelerated innovation, change during peak of pandemic
July 21, 2020 – ICUs filled up during the peak of the pandemic in Michigan this March. Out of necessity, the virus may have driven change within the healthcare system, including Henry Ford Health System (Detroit, MI) hospitals, faster than ever seen before. Other states sent spare ventilators to Michigan as thousands of patients with the new coronavirus arrived in emergency … [Read more...]
Quidel’s Sofia SARS Antigen FIA updates EUA performance data to 96.7% PPA vs PCR
July 20, 2020 – Quidel Corporation (San Diego, CA) announced it has updated the performance data for its Sofia SARS Antigen FIA test on its package insert to 96.7% using direct nasal swab specimens versus PCR as a result of further studies included in its amended Emergency Use Authorization (EUA) that were submitted to the U.S. Food and Drug Administration … [Read more...]
Thermo Fisher Scientific, First Genetics JCS partner to develop next-gen sequencing-based diagnostics in Russia
Thermo Fisher Scientific (Waltham, MA) and First Genetics JCS (Russia) announced a strategic partnership focused on commercializing next-generation sequencing (NGS)–based diagnostics in Russia. The agreement enables First Genetics to market its F-Genetics NGS System and IVD assays to Russian labs for reproductive health testing and cancer diagnostics. The F-Genetics System … [Read more...]
BD launches rapid point-of-care antigen test to detect COVID-19 in 15 minutes
BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with the company’s BD Veritor Plus System. This new assay delivers results in 15 minutes on an easy-to-use, highly portable instrument, which enables … [Read more...]