- Results in just 5 minutes from sample application, aids in fast
clinical decision-making at point of care (POC), helping to inform
treatment decisions and prevent the further spread of infection,
while also increasing testing throughput
- Run on the multi-assay LumiraDx Platform, the Ultra Test's
innovative strip design builds on the company's microfluidic
immunofluorescence technology enabling faster reaction times
without sacrificing sensitivity
- Available on the same POC Platform as LumiraDx's high
sensitivity SARS-CoV-2 Antigen, Flu A/B, SARS-CoV-2 Antibody,
SARS-CoV-2 Antigen Pool as well as INR, D-dimer and CRP tests*
LONDON, May 19, 2022
/PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation
point of care diagnostics company, today announced its SARS-CoV-2
Ag Ultra Test achieved CE Marking. The Ultra test provides digital
and connected results in just five minutes with high sensitivity,
making it one of the fastest and most sensitive COVID-19 antigen
tests available. The reduced time allows clinicians to treat
patients much faster, and increases throughput on the LumiraDx
Platform, now enabling users to complete up to 80 SARS-CoV-2
Antigen tests per eight-hour day, or up to 10 per hour, on a single
LumiraDx Instrument.
Advancements made with the Ultra test strip design reflect the
company's continued innovation of its microfluidic
immunofluorescence technology, allowing for higher sample volumes
to enter the test strip chambers to increase detection levels,
achieve faster reaction times and even greater precision. This new
technology is run on the existing LumiraDx Platform and can be
applied to future Platform tests.
The LumiraDx SARS-CoV-2 Ag Ultra Test matches the same
high-performance of the LumiraDx SARS-CoV-2 Ag 12 min test. The
test has a positive percent agreement of 92.7% and a negative
percent agreement of 100% versus RT-PCR in symptomatic individuals,
based on clinical data collected 0-12 days since symptom onset.
Within this cohort, The LumiraDx SARS-CoV-2 Ag Ultra test showed
high sensitivity of 97.4% up to a CT of 35 indicating high coverage
of potentially infectious individuals.
In addition, the LumiraDx SARS-CoV-2 Ag Ultra Test demonstrated
95.7% positive agreement versus RT-PCR in samples collected from
asymptomatic individuals. With the Omicron variant showing a much
higher rate of asymptomatic carriage compared to other variants,
the high sensitivity of the LumiraDx SARS-CoV-2 Ag Ultra Test can
be an important tool in breaking the chain of
transmission.1
Ron Zwanziger, LumiraDx's Chief Executive Officer explained,
"Our SARS-CoV-2 Ag Ultra Test exemplifies our mission to increase
access to testing and provide rapid diagnostics without sacrificing
accuracy. Now, clinicians, pharmacies and other providers can use a
single platform and significantly increase throughout, making a
profound impact on patient workflow supported by our Platform. This
innovation and advancement of our Microfluidic technology can also
be applied to other tests on our Platform which we look forward to
rolling out in the coming year."
Professor Jean-Paul Cristol, Head of the Division of
Biology Pathology at Montpellier University Hospital Center
commented, "The LumiraDx SARS-CoV-2 Ag
Test has been integrated in testing strategy in our
institution's adult, pediatric, obstetric and neurology emergency
departments since this January. The clinical accuracy allows us to
detect symptomatic and non-symptomatic patients and the
traceability of the results is ensured by the connection to our
middleware. In the emergency department, time is everything and
being able to provide these results in a shortened time can be
critical. A high-sensitivity, good traceability, and faster test
will be an optimal option to screen patients in emergency
departments."
The SARS-CoV-2 Ag Ultra test follows the successful launch of
LumiraDx's SARS-CoV-2 Antigen test which has been commercially
available for nearly two years.
About LumiraDx
LumiraDx (Nasdaq: LMDX) is a next-generation point of care
diagnostics company that is transforming community-based
healthcare. Founded in 2014, LumiraDx manufactures and
commercializes an innovative diagnostic Platform that supports a
broad menu of tests with lab comparable performance at the point of
care. LumiraDx diagnostic testing solutions are being deployed by
governments and leading healthcare institutions across
laboratories, urgent care, physician offices, pharmacies, schools,
and workplaces to screen, diagnose, and monitor wellness as well as
disease. LumiraDx has, on the market and in development, 30+ tests
covering infectious diseases, cardiovascular diseases, diabetes,
and coagulation disorders, all on the LumiraDx Platform. In
addition, LumiraDx has a comprehensive portfolio of fast, accurate,
and cost-efficient COVID-19 testing solutions from the lab to point
of need.
LumiraDx is based in the UK with more than 1600 employees
worldwide. Further information on LumiraDx and the LumiraDx
Platform is available at www.lumiradx.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995, including statements regarding the performance and benefits
of the SARS-CoV-2 Ag Ultra test. These statements involve risks,
uncertainties and other factors that may cause actual results,
levels of activity, performance or achievements to be materially
different from the information expressed or implied by these
forward-looking statements, including, among others, general
economic, political and business conditions; the effect of COVID-19
on LumiraDx's business and financial results; maintaining CE
marking for the SARS-CoV-2 Ag Ultra test and those factors
discussed under the header "Risk Factors" in the Annual Report on
Form 20-F for the year ended December
31, 2021, which was filed by LumiraDx with the Securities
and Exchange Commission ("SEC") on April 13,
2022, and other filings made by LumiraDx with the SEC.
Although LumiraDx believes that it has a reasonable basis for each
forward-looking statement contained in this press release, LumiraDx
cautions you that these statements are based on a combination of
facts and factors currently known by it and its projections of the
future, about which it cannot be certain. LumiraDx undertakes no
obligation to update or revise the information contained in this
press release, whether as a result of new information, future
events or circumstances or otherwise.
* Not all tests are available in all countries and regions. For
additional detail on product availability please
visit www.lumiradx.com.
1 Garrett N, Tapley A, Andriesen J, et al. High Rate of
Asymptomatic Carriage Associated with Variant Strain Omicron.
Preprint. medRxiv. 2022;2021.12.20.21268130. Published
2022 Jan 14. doi:10.1101/2021.12.20.21268130
Media Contact:
Colleen McMillen
Colleen.McMillen@lumiradx.com
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SOURCE LumiraDx