- The home COVID-19 test that tens of millions of Americans received through the US government is now available over the counter nationwide under the new name and brand name Pilot.
- Accurate, fast and easy to use, the Pilot COVID-19 at-home test is the first over-the-counter test launched by Roche Diagnostics in the US.
- Following the Centers for Disease Control and Prevention (CDC) guidance for home testing and appropriate next steps can help reduce the spread of COVID-19.
INDIANAPOLIS, November 10, 2022 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced a new name and brand for the in-home COVID-19 test: Pilot® COVID-19 Home Testwhich debuts this week across the country.
The COVID-19 home pilot test distributed by Roche Diagnostics is available from CVS, Amazon and the Optum store.
The COVID-19 at-home pilot test, the first OTC test distributed in the US by Roche Diagnostics, has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) the Dec. 24, 2021¹, and is manufactured by SD Biosensor Inc. The test has been distributed to tens of millions of Americans through the US government’s efforts to expand access to testing earlier this year. Uses a simple anterior nasal swab sample that can be conveniently collected and self-tested by individuals 14 years of age and older, and by an adult for children 2 to 13 years of age.² The Home COVID-19 Pilot Test is capable of producing accurate results , reliable and fast in just 20 minutes for SARS-CoV-2.
“Great progress has been made in making COVID-19 testing easy and universal,” he said. mate sauce, President and CEO of Roche Diagnostics North America. “We’re excited that the pilot will offer convenience and broad accessibility for frequent testing needs, whether it’s for known exposure or security for group settings.”
With a relative sensitivity of 93.2% and a relative specificity of 100%3home COVID-19 pilot testing can help you determine your next step, such as self-isolation for COVID-19, seeking further testing and seeking advice from a healthcare professional about treatment options, or ending isolation with two confirmed negative results. results.
Getting tested for COVID-19 at home is recommended by the CDC When: You have any symptoms of COVID-19; were exposed to someone with COVID-19; or go to an indoor event or meeting. If negative, consider repeat testing 48 hours later. Receiving multiple negative test results increases confidence that you are not infected with the virus that causes COVID-19. If you have symptoms, although serial testing may be helpful, seeing a health care provider should be considered because multiple viruses are currently circulating, including the flu.
In March 2020Roche became the first company to launch a commercial COVID-19 PCR test that runs on high-throughput laboratory instruments. The company has developed more than 20 COVID-19 tests and solutions globally and has sold more than 1.8 billion COVID-19 tests worldwide since the start of the pandemic. Roche offers high-quality solutions for all environments, from large reference laboratories to home testing. For more information on piloting COVID-19 at home, visit go.roche.com/COVID-Home-Test.
About the Home COVID-19 Pilot Test
The COVID-19 Home Pilot Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein present in previous nasal swab specimens. In a prospective clinical study, the pilot COVID-19 home test showed a relative sensitivity of 93.2% (95% CI: 81.8 to 97.7%) and a relative specificity of 100% (95% CI: 96.7 to 100%). Overall, the studies included 168 symptomatic people (158 evaluable samples).² This test is designed for*: 1) home use without a prescription (OTC) within the first 6 days of symptom onset, and 2) home use without a prescription, with or without symptoms or other epidemiological reasons to suspect COVID-19, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
*Persons 14 years of age and older may self-samples and self-test. Children ages 2-13 must be sampled and tested by an adult.
Variants including omicron BA.1, BA.2, BA.4, and BA.5 have been tested by SD Biosensor and no impact on test performance is anticipated.4
About SD Biosensor
SD Biosensor, Inc., with its tagline “The Beginning of All Things That Protect Lives,” is a global in vitro diagnostics company that helps improve the quality of life for everyone by diagnosing disease quickly and accurately. SD Biosensor is a total solution provider in the IVD industry that develops and researches innovative diagnostic platforms. In 2020, SD Biosensor, Inc. began supplying numerous WHO prequalified global public health diagnostic products, especially for malaria, HIV, and HCV.
Based on our R&D know-how, mass production capability and global sales network, SD Biosensor, Inc. will continue to grow as a global biotechnology company by creating new value through data accumulation. using AI, as well as in the areas of diagnostics, products, and services. For more information, please check our official website at www.sdbiosensor.com.
Founded in 1896 in Basel, SwitzerlandAs one of the first industrial manufacturers of branded medicines, Roche has become the world’s largest biotechnology company and a world leader in in vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics to improve and save the lives of people around the world. We are pioneers in personalized health care and want to further transform the way health care is delivered to make an even bigger impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharmacy with data insights from clinical practice.
In recognition of our effort to take a long-term perspective in everything we do, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to health care together with local partners in all the countries in which we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan.
For more information please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
 This product has not been cleared or approved by the FDA, but has been authorized by the FDA under an EUA for home use without a prescription (OTC) with self- and adult-collected anterior nasal swab specimens. This product has been authorized for the detection of SARS-CoV-2 proteins only, not for any other virus or pathogen.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist that warrant the authorization of the emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1). ) of the Federal Food, Drug, and Cosmetic Act, 21 USC §360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked earlier.
 SD biosensor. (2021). COVID-19 Home Test Package Insert.
 Study data on file with the National Institutes of Health, dated December 21, 2021. Sensitivity is the ability of the test to correctly identify a positive result and specificity is the ability of the test to correctly identify a negative result.
 Data on file with Roche Diagnostics.
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