Leaders in the Fight Against COVID-19: The Test Providers
by Diana Headrick, on April 16, 2020
A doctor recently interviewed about the COVID-19 pandemic said, “Testing is another form of personal protective equipment.” Not knowing who has the virus, and who may have had it, hampers our ability to defeat it. To this date, testing has been a slow process - limited to those who exhibit symptoms and meet specific criteria. Today, we feature the stories of Loftware customers, Abbot Laboratories, Becton Dickinson, DiaSorin and Hologic, who are all dedicating massive resources to develop faster diagnostic tests and speed those tests to market.
How do labels factor into this urgent battle? Labels provide the critical data to help ensure efficient delivery to customers and to document key aspects of the product. A mission-critical operation under normal conditions, accurate and efficient labeling is even more important today to increase the availability of testing during the pandemic.
Empowering Rapid Distribution for Testing
Abbott Laboratories received emergency use approval from the U.S. Food and Drug Administration for its rapid COVID-19 test designed for use in doctor’s offices, urgent care centers and smaller hospitals. Providing positive results in as few as five minutes and negative results in about 13 minutes, the test runs on Abbott’s ID NOW™ device, a portable device about the size of a toaster.
Becton Dickinson and Co has announced a partnership with diagnostics company BioMedomics to produce a diagnostic test that can detect current or past exposure to the coronavirus within minutes and can be used in doctors' offices and other settings. With a simple blood test that can be completed at the point of care, it does not require sending test swabs to a large laboratory, freeing up resources. Becton Dickinson will release the test in April under the FDA's recently relaxed rules for coronavirus tests and expects to have the capacity to produce one million tests, with the ability to scale up production further if necessary.
At the onset of the Covid-10 outbreak, DiaSorin S.p.A, a global leader in the laboratory diagnostics market, immediately initiated an R&D project to develop a rapid molecular kit to detect the COVID-19 in swabs. In late March, DiaSorin Molecular LLC, a division of DiaSorin, announced that it received Emergency Use Authorization (EUA) from the FDA for their Simplexa™ COVID-19 Direct kit. The kit contains a ready to use all-in-one reagent mix designed for use on DiaSorin’s LIAISON® MDX platform in hospital laboratories. The testing kit can identify all known strains of COVID-19 and provides much faster results – in about 60 minutes versus five to seven hours.
Hologic, a Massachusetts-based global leader in molecular diagnostics, announced that its molecular test for the novel coronavirus, SARS-CoV-2, received FDA emergency use authorization. This fully automated test runs on Hologic’s Panther Fusion ® diagnostic systems to detect genetic material from the new coronavirus strain in under three hours. The system’s automation speeds up testing and reduces the chances for error by eliminating many of the manual processes used in a traditional laboratory setting. Labs using Hologic's molecular diagnostic platform can process up to 1,150 tests in one day. Hologic began shipping tens of thousands of its tests to labs in March and plans to deliver around 600,000 tests in April, as it continues to ramp up production.
Ensuring Testing Kits Reach Their Destination
Labels serve as a passport to make sure products reach customers quickly and efficiently. Each of these companies use Loftware solutions to support their rapid increase in production. With the ability to produce data-driven labels that comply with global regulations faster and with more accuracy, Loftware solutions provide a scalable platform to meet their labeling and document requirements. And, because time is of the essence, Loftware’s support and services teams are available around the globe ready to assist with new or expanded requirements, answer customers’ questions and solve problems. It’s what we do.