LONDON, Dec. 15, 2021 /PRNewswire/ -- LumiraDx (Nasdaq:
LMDX) today announced a partnership with digital health non-profit
Audere, to offer a self-collected COVID-19 nasal specimen
collection kit that has been authorized for use with the LumiraDx
SARS-CoV-2 RNA STAR Complete assay to process self-collected
samples. Audere's testing solution, HealthPulse@home, closely
aligns with LumiraDx's continual efforts to increase testing access
and support a growing number of testing needs.
Laboratories utilizing the SARS-CoV-2 RNA STAR Complete will be
able to integrate HealthPulse@home into their systems. Using
HealthPulse@home authorized labeling instructions, labs can provide
their own specimen collection kit solution that fits into the lab's
preference of kit registration, accessioning, and flexibility of
shipping carriers. The HealthPulse@home solution is designed for
efficiency and simplicity and requires no additional usability
studies.
Sanjay Malkani, President,
LumiraDx Fast Lab Solutions stated, "With the recent FDA EUA
Intended Use expansion on the LumiraDx SARS-CoV-2 RNA STAR
Complete, we are bringing access to innovative testing solutions
right to the community - whether through high sensitivity mobile
molecular labs or through the convenience of superior, simple,
remote self-collection technologies with Audere. By working with
Audere, and providing remote collection, we further enable high
quality, cost-effective, convenient, and accurate testing that fits
into the needs of the clinic and individuals."
Paul Isabelli, Chief Operating
Officer, Audere, stated "We are excited to partner with
LumiraDx and further its mission to provide quality and highly
accessible testing solutions that fit the needs of the Lumira Dx
Fast Lab Solutions network and the clinics and individuals it
serves. The use of HealthPulse@home in conjunction with LumiraDx
SARS-CoV-2 RNA STAR Complete will broaden access to self-testing
solutions, allowing individuals to confidently continue on the path
to normalcy."
EUA Status of LumiraDx SARS-CoV-2 RNA STAR
Complete
The LumiraDx SARS-CoV-2 RNA STAR Complete has not
been FDA cleared or approved but has been authorized by FDA for
emergency use under an EUA for use by authorized
laboratories. The LumiraDX SARS-CoV-2 RNA STAR Complete has
been authorized only for the detection of nucleic acid from
SARS-CoV-2, not for any other viruses or pathogens. The emergency
use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization
of emergency use of in vitro diagnostic tests for detection and/or
diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food,
Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
declaration is terminated, or authorization is revoked sooner.
About LumiraDx Fast Lab Solutions
LumiraDx Fast Lab Solutions is a dedicated LumiraDx business
unit that supports high-complexity laboratory testing by utilizing
its innovative qSTAR nucleic acid amplification technology in an
accessible high-throughput format to leverage current molecular
laboratory operations. Utilizing Fast Lab Solutions enables
laboratories to improve efficiency and reduce time to result.
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
About Audere
Audere is a Seattle-based
digital health nonprofit developing solutions to improve global
health outcomes in the world's most underserved communities. Our
team of passionate, innovative minds advances health equity by
revolutionizing the detection and treatment of diseases, such as
malaria, COVID-19, and HIV. Through a deep understanding of key
global health needs, Audere combines smartphone technology,
computer vision & machine learning, and the best of cloud-based
services to deliver tailored healthcare technology solutions
worldwide. Development of our projects is funded by grants from the
Bill & Melinda Gates Foundation and Justworks. Learn more at
auderenow.org.
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 integration of the
LumiraDx SARS-CoV-2 RNA STAR Complete Audere's technologies and the
associated benefits and synergies. 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 EUA
approval for the LumiraDx SARS-CoV-2 RNA Star Complete and those
factors discussed under the header "Risk Factors" in the Proxy
Statement and Prospectus filed pursuant to Rule 424B(3) with the Securities and Exchange
Commission ("SEC") on September 10,
2021 and other filings 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.
Media Contact:
Colleen.McMillen@lumiradx.com
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SOURCE LumiraDx