September 4, 2020 - Roche (Basel, Switzerland) announced that the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B in … [Read more...]
OraSure’s ORAcollect·RNA device included in EUA granted to MiraDx Inc. for SARS-CoV-2 test
September 4, 2020 - OraSure Technologies, Inc. (Bethlehem, PA) announced that its ORAcollect·RNA (OR-100) collection device was included along with other devices in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to MiraDx Inc. (Los Angeles, CA), a molecular genetics company. This is the fifth EUA to include a collection device from the … [Read more...]
Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE Mark
September 2, 2020 - Roche (Basel, Switzerland) announced it will launch a SARS-CoV-2 Rapid Antigen Test in late September for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Rapid Antigen Test is for use in point-of-care (POC) settings for both … [Read more...]
Thermo Fisher opens new site for manufacturing COVID-19 sample collection products
August 28, 2020 - Thermo Fisher Scientific Inc. (Boston, MA) announced that it has officially cut the ribbon on its new $40 million facility in Lenexa, Kansas, dedicated to viral transport media (VTM) production. The company also announced that the site will continue to expand to meet expected sustained demand for COVID-19 testing. Thermo Fisher says the facility has … [Read more...]
Quidel provides business update, isn’t concerned by Abbott’s new SARS antigen test
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...]
Abbott releases fast, $5 COVID-19 antigen test, free mobile app to display test results
August 27, 2020 - Abbott (Abbott Park, IL) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection. The company says it will sell this test for $5. Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are … [Read more...]
Rural hospitals are sinking under COVID-19 financial pressures
August 27, 2020 - As COVID-19 continues to spread, an increasing number of rural communities in the U.S. find themselves without their hospital or on the brink of losing already cash-strapped facilities, reports NPR. Eighteen rural hospitals closed last year and the first three months of 2020 were "really big months," says Mark Holmes, director of the Cecil G. Sheps Center … [Read more...]
Supporting Our Healthcare Workers During a Scarcity of Disinfectants
From the upcoming September issue of Repertoire Magazine August 26, 2020 - Surface disinfection wipes are scarce in the face of a pandemic. The global supply chain of surface disinfectants has been heavily impacted by the pandemic, and limitations on ordering have happened as a result of raw material and extensive back orders throughout the industry. Understanding the … [Read more...]
CMS Updates Reporting, Testing Requirements for Labs, Healthcare Providers
August 26, 2020 - The Centers for Medicare & Medicaid Services (CMS) announced sweeping regulatory changes that require labs and other healthcare providers to test staff and offer testing to residents for COVID-19. Labs and nursing homes using point-of-care (POC) testing devices will be required to report diagnostic test results as required by the CARES Act (Coronavirus … [Read more...]
Quidel to update packaging of POC Sofia SARS Antigen test for COVID-19 to include either nasal or nasopharyngeal swabs
August 20, 2020 - Quidel Corporation announecd that labeling for Quidel’s Emergency Use Authorization (EUA) for the Sofia SARS Antigen FIA has been amended to include either nasal or nasopharyngeal swabs. The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample … [Read more...]