August 28, 2020 - Quidel Corporation (San Diego, CA) yesterday announced business updates and reaffirmed that it is “an industry leader in the introduction of FDA-authorized rapid tests for a wide range of diseases and medical conditions, [and] remains in the forefront of the battle against the COVID-19 pandemic.” Competition Was Expected “Abbott’s entry into the SARS … [Read more...]
BD Veritor System for COVID-19 testing now available
From the upcoming September edition of Repertoire Magazine. August 20, 2020 - Designed to meet the evolving and critical needs of point-of-care (POC) testing, the BD Veritor Plus system enables you to streamline the testing experience. Be ready for flu season by testing with CLIA-waived Flu A+B, Group A Strep, and respiratory syncytial virus (RSV) assays along with the … [Read more...]
Thermo Fisher develops COVID-19 antibody assay for transplant community
August 10, 2020 - Thermo Fisher Scientific (Waltham, MA) has developed a new serological assay targeted towards transplant candidates and recipients that can detect antibodies directed against COVID-19 (SARS-CoV-2). The assay will be provided under the company's One Lambda brand. In collaboration with histocompatibility, infectious disease and nephrology laboratories at … [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...]
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...]
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...]
Stat-Technologies receives Emergency Use Authorization for COVID-19 IgG/IgN rapid test kits
Stat-Technologies (Golden Valley, MN) announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for the COVID-19 IgG/IgN rapid test kits it carries. The tests offered by Stat-technologies are manufactured by Healgen Scientific. According to the company, the FDA authorization and Preferred-Provider status allows … [Read more...]
Quidel receives BARDA funding to develop point-of-care diagnostic assay that includes COVID-19
Quidel Corporation (San Diego, CA) announced it has received funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to support the development of a point-of-care diagnostic assay that potentially tests for four … [Read more...]
Quidel receives amended Emergency Authorization for rapid antigen COVID-19 diagnostic assay using Sofia 1 instrument
Quidel Corporation (San Diego, CA) announced it has received an amended Emergency Use Authorization (EUA) from the FDA, allowing Quidel to run its Sofia SARS Antigen FIA, a rapid point-of-care test for COVID-19, on the Sofia Fluorescent Immunoassay Analyzer (Sofia 1), Quidel’s first-generation automated immunoassay instrument. Quidel previously received EUA to run the Sofia … [Read more...]