2San's Genabio® COVID-19 Rapid Self-Test Kit Cleared for Emergency Use by FDA Now Available on Amazon Prime

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

-The self-test kit can detect the latest worrying variants of SARS-CoV-2

– Most affordable home self-test kit on the US market

LONDON, November 21, 2022–(BUSINESS WIRE)–2San today announced that the Genabio® COVID-19 Rapid Self-Test Kit, which this year received Emergency Use Authorization from the FDA1, 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 United States3 The test kit is now available in the United States at a time when virus infections are on the rise during a busy holiday season.

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2San’s Genabio® COVID-19 rapid self-test kit cleared for emergency use by the FDA is now available on Amazon Prime (Photo: Business Wire)

2San is a leading global medical device distributor, based in the UK, with offices in the US. With a vision to empower people around the world to take charge of 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 US market.

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

The Genabio® self-test kit presents excellent overall performance. It identifies infection of all existing variants of SARS-CoV-2 with a sensitivity of 91.89% and specificity of 100% based on clinical data.4 The test’s high sensitivity and specificity ensure reliable results for both symptomatic and asymptomatic individuals. The kit is easy to use and the whole process can be done at home with results available in just 15 minutes.2 People 14 or older can administer the test independently, and adults can easily help anyone younger.2

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

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

About the Genabio® COVID-19 rapid self-test kit

The Genabio® COVID-19 rapid self-test kit is a novel rapid immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid (N) protein antigen. Omicron (B.1.1.529) is a SARS-CoV-2 variant first reported to the World Health Organization (WHO) by the Genomic Surveillance Network in South Africa on November 24, 2021.5 It was first detected in Botswana and has spread to become the predominant variant circulating worldwide.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 swabs conducted at two experimental sites in the United States. The Genabio® COVID-19 rapid self-test kit correctly identified infection from nasal swabs with a sensitivity of 91.89% and a specificity of 100% in symptomatic patients.4.5 In asymptomatic patients, the Genabio® COVID-19 rapid self-test kit identified infection with a sensitivity of 86.0% and a specificity of 100%.4 The test accurately predicted 100% of infections in symptomatic and non-symptomatic patients, as well as no infections in 98.8% of asymptomatic patients.4

About 2San

2San is one of the world’s leading providers of self-diagnostic test kits, dedicated to improving patient care by making the highest quality tests accessible and affordable for customers around the world. 2San operates in over 20 markets worldwide and has distributed over 250 million COVID tests during the pandemic. With operations spanning four continents, 2San provides unparalleled access to specialized market knowledge and global distribution capabilities, creating agile supply chains and growing a world-class partner ecosystem.

Visit www.2san.com to learn more.

For more information on 2San self-diagnostics, 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 – Authorization Letter. 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.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20221121005507/en/

contacts

Tahmid Khan
X-ray medical dynamics
Number: +1 (646) – 934 – 1916
Email: tkhan@rxmedyn.com

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