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Draft:2San

From Wikipedia, the free encyclopedia

2San
TypePrivate
IndustryMedical device, In vitro diagnostics
FoundedMay 26, 2020; 6 years ago (2020-05-26) in United Kingdom
HeadquartersCarnforth, Lancashire, England
Area served
United Kingdom, Australia, United States, Canada
Key people
Mark Hewlett (CEO)
ProductsCOVID-19 tests, diagnostic test kits, cleaning products
Websitewww.2san.com

2San is a British-Australian healthcare and medical diagnostics company that supplies COVID-19 diagnostic tests, self-diagnostic medical devices, and cleaning products internationally. Founded during the COVID-19 pandemic, the company claims to have distributed over 250 million COVID tests globally and operate in over 20 markets.[1]

The company gained public attention through its connections to members of the Plymouth Brethren Christian Church and regulatory issues with the Australian Therapeutic Goods Administration.

Ownership

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2San's UK affiliate was started and is owned by Dean Hales. Hales is the son of Bruce Hales, the Plymouth Brethren Christian Church (PBCC) global leader.[2] Simon Whiley, formerly a director of the UK PBCC, was director of 2San's Australia affiliate.[2] Many companies linked to members of the Plymouth Brethren won government contracts in the United Kingdom and Australia during the pandemic.[2]

In April 2022, Mark Hewlett joined 2San as Chief Executive Officer.[3] Hewlett had served as Director of Testing for the UK Health Security Agency until two weeks before joining 2San.[citation needed]

History

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Founding and COVID-19 pandemic

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On 26 May 2020, 2San Global Limited was incorporated in the United Kingdom, at the onset of the COVID-19 pandemic.[4] 2San was established by Dean Hales.[2]

In 2020, 2San's Australian subsidiary, 2San Pty Ltd, won government contracts during the pandemic to supply COVID-19 testing materials. According to The New Daily, 2San was awarded $26 million AUD by the Australian Department of Health to provide medical equipment and accessories.[2] The ACT government paid 2San approximately $5 million AUD for the supply of COVID tests.[2] The company also secured contracts with the NSW government.[2][clarification needed]

In 2022, 2San claimed that it had distributed 250 million COVID tests globally.[1]

In January 2023, 2San acquired Craftex Cleaning Systems, a UK-based provider of cleaning products.[5]

In February 2023, 2San partnered with LloydsPharmacy in the United Kingdom to sell eight over-the-counter self-test kits countrywide.[6] In May 2023, 2San partnered with Coles Supermarkets in Australia to sell self-test kits countrywide.[3] 2San's diagnostic products are distributed through major retail chains in the United Kingdom, Australia, and the United States.[citation needed]

Australian regulatory actions

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In August 2022, the Australian Therapeutic Goods Administration (TGA) issued five infringement notices totaling $66,600 AUD to 2San for allegedly failing to provide information to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests.[7] 2San tests had excessively high false negative results.[8]

In July 2024, the TGA accepted a court-enforceable undertaking from 2San Pty Ltd after the company unlawfully imported and supplied therapeutic goods not included in the Australian Register of Therapeutic Goods. These products, which included bacterial vaginosis tests and pregnancy test kits, were sold through a national retailer before being recalled.[9] The undertaking required 2San to conduct annual audits, implement product recalls, and seek ISO 13485 certification.[9]

Media coverage

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In September 2025, the ABC's Four Corners program broadcast "Big Brethren", an investigation by Louise Milligan into the Plymouth Brethren Christian Church's business interests. ABC claimed that companies connected to the church had "amassed billions" and were "under scrutiny from the Australian Taxation Office".[10][clarification needed]

See also

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References

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  1. ^ a b "2San's FDA Emergency Use Authorized Genabio® COVID-19 Rapid Self-Test Kit Now Available on Amazon Prime" (Press release). Business Wire. 2022-11-21. Retrieved 2025-01-14.
  2. ^ a b c d e f g Robertson, James (2023-01-29). "Exclusive Brethren major PPE suppliers to Australian government". The New Daily. Retrieved 2025-01-14.
  3. ^ a b "2San partners with Coles to make rapid self-testing more accessible". Inside FMCG. 2023-05-22. Retrieved 2025-01-14.
  4. ^ "2SAN GLOBAL LIMITED - Company Overview". Companies House. Retrieved 2025-01-14.
  5. ^ "2San Makes UK Acquisition". European Cleaning Journal. 2023-02-21. Retrieved 2025-01-14.
  6. ^ "2San and LloydsPharmacy Partner to Bring Affordable and Accessible Diagnostic Tests To Market". PharmiWeb. 2023-02-21. Retrieved 2025-01-14.
  7. ^ "2San Pty Ltd fined $66,600 for allegedly failing to provide ongoing evidence to support the performance of its COVID-19 rapid antigen tests". Therapeutic Goods Administration. 2022-08-10. Retrieved 2025-01-14.
  8. ^ Holmes, Dan (2022-08-11). "Two RAT manufacturers fined by TGA". The Mandarin. Retrieved 2025-01-14.
  9. ^ a b "2San Pty Ltd enters into enforceable undertaking after unlawful import and supply of medical devices". Therapeutic Goods Administration. 2024-07-01. Retrieved 2025-01-14.
  10. ^ Reporter: Louise Milligan; Producer: Nick Farrow (2025-09-15). "Big Brethren". Four Corners. ABC. {{cite episode}}: |access-date= requires |url= (help)
[edit]

Category:British companies established in 2020 Category:Companies based in Lancashire Category:Medical technology companies of the United Kingdom Category:COVID-19 pandemic in the United Kingdom Category:COVID-19 pandemic in Australia