2San’s FDA Emergency Use Authorized Genabio® COVID-19 Rapid Self-Test Kit Now Available on Amazon Prime

-Self-Test Kit can detect the latest SARS-CoV-2 variants of concern

-Most affordable at-home self-test kit on the U.S. market

LONDON--(BUSINESS WIRE)--2San announced today that the Genabio® COVID-19 Rapid Self-Test Kit, which received FDA Emergency Use Authorization this year¹, is now available on Amazon. The Genabio® Self-Test Kit positively predicts 100% of SARS-CoV-2 infections with all variants of concern. It has an 18-month shelf life for extended home use, the longest of any available on the market² and is reimbursable by most insurers in the U.S.³ The test kit is now available across the U.S. at a time when viral infections are on the rise during a busy holiday travel season.

2San is a global distributor of leading medical devices, based in the UK, with offices in the US. With a vision to empower people everywhere to own their own health, 2San designs and delivers innovative healthcare products to help people make informed decisions to live better, healthier lives. The availability of the Genabio® Self-Test Kit on Amazon now brings another of 2San’s innovative products to the U.S. market.

“As we enter the viral infection season, we need to protect ourselves and our families from developing COVID-19 – especially during our holiday travels when we are at higher risk,” said Mark Hewlett, CEO of 2San, “Our highly sensitive, dependable, and affordable self-test kit allows consumers to protect themselves and their loved ones from illness. At 2San, we encourage everyone to take responsibility for their own health and we provide the resources for them to make informed decisions.”

The Genabio® Self-Test Kit exhibits excellent overall performance characteristics. It identifies infection of all existing SARS-CoV-2 variants with 91.89% sensitivity and 100% specificity based on clinical data.⁴ The test’s high sensitivity and specificity assures reliable results for both symptomatic and asymptomatic individuals. The kit is easy to use and the whole process can be completed at home with results available in just 15 minutes.² Individuals 14 years or older can independently administer the test and adults can easily assist anyone who is younger.²

“Self-testing with a kit that detects the latest SARS-CoV-2 variants empowers each of us to keep this virus localized. The clinical data demonstrates that the test delivers highly predictive positive results from all COVID-19 variants of concern, including the newer subvariants of Omicron, making it one of the most robust self-tests on the market,” said Valerie Palmieri, Scientific Advisor to 2San. “The high-quality and overall performance of the self-test along with it being the most affordable and sustainable product on the market makes it a great option for infection control.”

The test is currently available on Amazon Prime and with Prime shipping:

• Genabio COVID-19 Rapid Self-Test Kit $9.99 USD for a single test kit or $15.99 for a two-test kit pack.

About Genabio® COVID-19 Rapid Self-Test Kit

The Genabio® COVID-19 Rapid Self-Test Kit is a novel rapid immunoassay intended for the qualitative detection of nucleocapsid (N) protein antigen from SARS-CoV-2. Omicron (B.1.1.529) is a variant of SARS-CoV-2 first reported to the World health Organization (WHO) by the Network for Genomics Surveillance in South Africa November 24, 2021.⁵ It was first detected in Botswana and has spread to become the predominant variant in circulation around the world.⁵ The Genabio® COVID-19 Rapid Self-Test Kit was compared with RT-PCR kit and Next Generation Sequencing (NGS) in a clinical study of 160 nasal swab conducted at two investigational sites in the United States. The Genabio® COVID-19 Rapid Self-Test Kit correctly identified infection from nasal swabs with a 91.89% sensitivity and 100% specificity from symptomatic patients.^4,5 From asymptomatic patients the Genabio® COVID-19 Rapid Self-Test Kit identified infection with an 86.0% sensitivity and 100% specificity.⁴ The test accurately predicted 100% of infections in both symptomatic and non-symptomatic patients as well as no infection in 98.8% of asymptomatic patients.⁴

About 2San

2San is a leading global supplier of self-diagnostic test kits, dedicated to improving care by making the highest quality tests accessible and affordable to customers around the world. 2San operates in more than 20 markets worldwide and has distributed over 250 million COVID tests over the course of the pandemic. With operations spanning four continents, 2San offers unrivalled access to specialized market knowledge and global distribution capabilities, building agile supply chains, and developing an ecosystem of world-class partners.

Visit www.2san.com to learn more.

For more information about 2San Self Diagnostic tests visit https://2san.com/self-diagnostics

Connect with 2San on LinkedIn by visiting https://www.linkedin.com/company/2san/.

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References

1. Food and Drug Administration (FDA). Genabio® COVID-19 Rapid Self-Test Kit – Letter of Authorization. https://www.fda.gov/media/159831/download. Accessed November 18, 2022.
2. Food and Drug Administration (FDA). Genabio® COVID-19 Rapid Self-Test Kit. https://www.fda.gov/media/159833/download. Accessed November 18, 2022.
3. Amazon. Genabio COVID-19 Rapid Self-Test Kit. Accessed November 18, 2022.
4. 2San. Genabio Diagnostics Inc. Genabio COVID-19 Rapid Self-Test Kit Clinical Trial Report. Data on file. Accessed November 18, 2022.
5. 2San. Data on File. Accessed November 18, 2022.