LumiraDx Announces Commercial Launch of its SARS-CoV-2 Ag Pool Test in CE Mark countries
- Test can screen up to 5 individuals suspected of COVID-19 or up to 5 asymptomatic individuals
London, UK (17 June 2021): Today, LumiraDx, a next-generation point of care (POC) diagnostics testing company announced the official commercial launch of its SARS-CoV-2 Ag Pool Test in Europe. The highly accurate test supports screening programs in settings including events, workplace, school and travel, reducing unnecessary disruptions while ensuring the health of groups. The test received CE mark earlier this spring with limited availability and is now commercially available across Europe.
Used with the LumiraDx Platform, the test offers a rapid, scalable and cost-effective screening solution for infectious individuals.
David Walton, LumiraDx Chief Commercial officer explained, “Whether it’s a football match, concert, or the theater, screening groups is an important part in safely resuming large gatherings, giving attendees ease of mind, and serves as a critical tool for us to contain the spread of this virus and its new variants. The ability to test five individuals simultaneously makes the SARS-CoV-2 Ag Pool Test an efficient, accurate and economical way to implement a high-quality and thorough screening program.”
Pilot customers in Italy and Germany, including P.T.B. Sicherheitsmanagement GmbH (Corona Test Station Berlin), have already used the SARS-CoV-2 Ag Pool Test for sporting events, museum entry and festivals. P.T.B. General Manager Arne Fritsche commented, “LumiraDx’s SARS-CoV-2 Ag Pool Test has helped us to provide reliable and highly accurate testing and optimize the attendee process at events, such as currently for the Berlinale Summer Special, Berlin Philharmonic concert at Waldbühne Berlin, ALBA Basketball matches at Mercedes Benz Arena Berlin and for the Handball matches of Berliner Füchse at Max Schmeling Halle Berlin. Testing takes place either decentrally at the various CTSB testing stations or mobile at the event locations before entering the event. Attendees receive a digital notification of their test result after just a few minutes and can then enter the venue with a negative test result. In this way, we achieve maximum safety for the health of all those present as well as a fast and uncomplicated admission situation."
In clinical studies, the LumiraDx SARS-CoV-2 antigen pool test demonstrated 100% positive agreement and 96.6% negative agreement when compared to testing individual swabs on the LumiraDx SARS-COV-2 Ag Test. The LumiraDx SARS-CoV-2 Ag Test is a high sensitivity antigen test that combines high performance and speed to an actionable result. In clinical studies, it demonstrated a 97.6% positive agreement and 96.6% negative agreement with RT-PCR in patients within 12 days of symptom onset.
Pooling testing has been shown to significantly reduce resources, including tests, operators, ad instruments, required on a per-patient basis. In addition, as up to five swabs may be tested simultaneously, testing time is reduced as much as 60 percent allowing for efficient and seamless entry protocols in large venues and other group settings.
LumiraDx was founded in 2014 by a group of entrepreneurs: Ron Zwanziger, our Chairman and Chief Executive Officer; Dave Scott, Ph.D., our Chief Technology Officer; and Jerry McAleer, Ph.D., our Chief Scientist, who have a successful track record in building and scaling diagnostics businesses over three decades, including at companies such as Medisense, Inc., Inverness Medical Technology Inc. and Alere Inc. The company is supported by institutional and strategic investors including the Bill & Melinda Gates Foundation, Morningside Ventures, U.S. Boston Capital Corporation, and Petrichor Healthcare Capital Management. Based in the UK and supported by its worldwide affiliates to provide access in all major markets, LumiraDx has more than 1,200 employees worldwide.
LumiraDx develops, manufactures and commercializes an innovative point of care diagnostic Platform. The LumiraDx Platform is designed to deliver lab comparable diagnostic results at the point of care in minutes. It is designed to be affordable and accessible for healthcare providers globally, and to strengthen community-based healthcare.