Source : Medtech Insight
A COVID-19 test recently cleared for over-the-counter (OTC) sales in the US will do more than expand consumer access to tests for infections.
The National Institutes of Health is paying for 2 million Quidel Corporation QuickVue At-Home tests to use in a program it’s conducting with the Centers for Disease Control to determine whether frequent self-administered testing helps reduce community transmission.
“If self-testing is shown to effectively reduce viral spread in the selected communities, the hope is that it will lead to wider distribution and acceptance of frequent home testing across the country – ultimately providing an easy and accessible new means of stemming the spread of the virus,” said Elizabeth DiNenno, associate deputy director for surveillance, epidemiology, and laboratory sciences at the CDC.
“We hope to gain foundational data that can guide how communities can use self-administered tests to mitigate viral transmission during this and future pandemics." – Francis Collins
“Quidel has worked to support the greatest need and the greatest good as we democratize access to frequent and affordable coronavirus testing. This partnership with CDC and NIH to show the power of serial testing to contain virus spread in underserved communities is emblematic of that commitment,” said Douglas Bryant, the San Diego-based firm’s president and CEO, in a release.
In its 1 April announcement, NIH said CDC launched the “Say Yes! COVID Test” initiative in Pitt County, NC, and will expand it to Chattanooga and Hamilton County, TN, to provide many as 160,000 residents free access to the rapid antigen tests to use three times a week for one month.
Quidel’s QuickVue test received an emergency use authorization (EUA) for OTC sales from the Food and Drug Administration in March. A companion online tool from Michigan-based CareEvolution, developed with funding from NIH, is customized for use with the QuickVue test. ()
NIH explained that participants, through local health departments, will order test kits online for home delivery or to receive at local distribution sites. CareEvolution’s online tool, also available as a smartphone app, will be offered to provide testing instructions, information to help understand test results and text message reminders about testing.
NIH is funding the Say Yes! initiative as part of its Rapid Acceleration of Diagnostics (RADxUP) initiative. RADxUP also is analyzing data that participants volunteer in surveys designed to determine whether frequent self-administered testing has made a difference in behavior, knowledge on preventing spread of SARS-CoV-2, the virus that causes COVID-19, and thoughts about COVID-19 vaccination.
“We hope to gain foundational data that can guide how communities can use self-administered tests to mitigate viral transmission during this and future pandemics,” said NIH Director Francis Collins.
The communities in southeastern North Carolina and eastern Tennessee were selected for the program based on local infection rates, public availability of accurate COVID-19 tracking data, existing community relationships through RADxUP and local infrastructure to support the project, according to NIH.
The Consumer Healthcare Products Association notes that the FDA’s EUAs of OTC self-testing products for COVID-19 adds to the market for consumer medical devices that helps save $8bn in other costs to the US health care system annually.
“Consumer medical devices, including diagnostic products like these, are critical health tools that enable consumers to monitor and self-assess their COVID-19 status quickly, safely, accurately, and frequently without spending time or money on visits to a doctor’s office,” said CHPA in a statement.
Other consumer medical devices also have been key factors in responding to the pandemic and attempting to slow prevent COVID-19’s spread. CHPA notes US consumers are relying on devices including face masks, thermometers, pulse oximeters, analgesic patches, surgical gloves and others to stay healthy.
“The critical importance of consumer medical devices to public health has been highlighted during the COVID-19 pandemic Now, access to OTC self-test kits empowers even more self-care, which is especially important as states are loosening pandemic-related social restrictions, Americans begin returning to schools and offices, and the summer travel season approaches,” the trade group said.
When it granted an EUA for QuickVue, the FDA noted it has published multiple guidances to streamline the process for test developers interested in authorization for screening with serial testing to increase consumer access to testing, as well as information the FDA has issued to help schools, workplaces, communities, and others establish screening programs. ()
[ Editor's Note: This article originally appeared on Informa's HBW Insight, the source for news and insight on the OTC drug, DTC medical device, cosmetics and dietary supplement industries.]
By Malcolm Spicer