3/17/2020 SAN DIEGO--(BUSINESS WIRE) Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Lyra® SARS-CoV-2 Assay, a real-time RT-PCR test intended for the … [Read more...]
Coronavirus News – March 17
First human trial starts in U.S. The first human trial testing a potential vaccine to prevent COVID-19 began Monday. The NIH has been fast-tracking work with biotech company Moderna to develop a vaccine using the genetic sequence of the new coronavirus. The trial is taking place at the Kaiser Permanente Washington Health Research Institute (Seattle, WA), where COVID-19 cases … [Read more...]
Dail-eNews Podcast – PPE availability during COVID-19
Dail-eNews editor Daniel Beaird interviews Repertoire editor Mark Thill about the FDA's letter to healthcare providers on surgical mask and gown conservation strategies and the possible re-use of PPE during the COVID-19 pandemic. … [Read more...]
COVID-19 Testing: What reps need to know
(March 16, 2020) - Repertoire Physician Office Lab Columnist, Jim Poggi, provides some insights into the COVID-19 testing methods All the testing for coronavirus in the US is under the direction of the CDC. There are presently three methods approved: The CDC created method, which has been sent to public health labs in the U.S. Roche has … [Read more...]
Coronavirus News – March 16
FDA issues Emergency Use Authorization to Thermo Fisher On Friday, the FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. The FDA issued an EUA to Thermo Fisher for its diagnostic test within 24 hours of receiving the request. This is the second commercially distributed test to receive an EUA during … [Read more...]
Henry Schein offers outlook for product availability
March 16, 2020 Henry Schein Chairman and CEO Stanley Bergman told customers in a March 12 letter that the company is working to procure products from existing as well as alternate suppliers, but to expect some product shortages in the weeks ahead. The company is rationing shipments of product to existing customers only, he added. Bergman provided Henry Schein’s outlook … [Read more...]
Coronavirus News – March 13
Johnson & Johnson’s business continuity statement Johnson & Johnson today released a business continuity statement in relation to the COVID-19 pandemic. “Johnson & Johnson is closely monitoring the COVID-19 (coronavirus) situation and taking steps to help prevent the spread of the virus as well as exploring the potential for a vaccine,” the company wrote. “We … [Read more...]
FDA to providers: Be strategic, be safe in your use of surgical masks and gowns
No surprise here: The need for personal protective equipment (e.g., surgical masks, surgical and isolation gowns, and scrub suits) may outpace the supply available to healthcare providers during the COVID-19 outbreak. That word came from the FDA in a March 11 letter to providers. So what are providers to do? First of all, they should RESIST the temptation to toss out all the … [Read more...]
Coronavirus News – March 12
President Trump suspends travel from Europe for 30 days President Donald Trump has announced sweeping travel restrictions - suspending travel for 30 days -- on 26 European countries in a bid to combat the spread of the coronavirus. It includes countries within the Schengen Agreement, which abolished many of the European Union’s (EU) internal borders, enabling passport-free … [Read more...]
Coronavirus News – March 11
BREAKING: WHO Declares Coronavirus Outbreak a Pandemic The World Health Organization (WHO) has declared the novel coronavirus a pandemic as it spreads in more than 100 countries around the world. The WHO said it was deeply concerned by the "alarming levels of inaction" about the coronavirus outbreak but described the term "pandemic" as both a "characterization" and a … [Read more...]