The COVID-19 At-Home Test that tens of millions of Americans received via the U.S. government is now available over-the-counter nationwide under the new Pilot name and brand.
The COVID-19 At-Home Test distributed by Roche. (Credit: PRNewsfoto/Roche)
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced a new name and brand for the COVID-19 At-Home Test – Pilot® COVID-19 At-Home Test, which debuts this week nationwide.
The Pilot COVID-19 At-Home Test, the first over-the-counter test distributed in the U.S. by Roche Diagnostics, received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) on December 24, 2021¹, and is manufactured by SD Biosensor Inc. The test has been distributed to tens of millions of Americans via the U.S. government’s efforts to expand access to testing earlier this year. It uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals ages 14 years and older, and by an adult for children ages 2 to 13 years old.² The Pilot COVID-19 At-Home Test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2.
“Great progress has been made to make COVID-19 testing easy and universal,” said Matt Sause, president and CEO of Roche Diagnostics North America. “We are excited that the Pilot test offers convenience and broad accessibility for frequent testing needs, whether for a known exposure or safety for group settings.”
With a relative sensitivity of 93.2% and a relative specificity of 100%3, the Pilot COVID-19 At-Home Test can help you determine your next step, such as self-isolation for COVID-19, seeking further testing, and pursuing advice from a healthcare professional about treatment options, or ending isolation with two confirmed negative results.
Taking an at-home COVID-19 test is recommended by the CDC when you: have any COVID-19 symptoms; were exposed to someone with COVID-19; or are going to an indoor event or gathering. If you test negative, consider repeating the test 48 hours later. Receiving multiple negative test results increases the confidence that you are not infected with the virus that causes COVID-19. If you have symptoms, although serial testing may be useful, seeing a healthcare provider should be considered because multiple viruses including the flu are currently circulating.
The Pilot COVID-19 At-Home Test is available at CVS Pharmacy and cvs.com, Amazon and in the Optum Store.
In March 2020, Roche became the first company to launch a commercial COVID-19 PCR test running on high-throughput laboratory instruments. The company has developed more than 20 COVID-19 tests and solutions globally, and sold more than 1.8 billion COVID-19 tests worldwide since the beginning of the pandemic. Roche offers high-quality solutions for every setting, from large reference laboratories to at-home testing. For more information about the Pilot COVID-19 At-Home Test, visit go.roche.com/COVID-Home-Test.
Source: Company Press Release