LONDON, Jan. 11, 2022 /PRNewswire/ -- LumiraDx (Nasdaq:
LMDX), a next-generation point of care diagnostics company, today
announced its C-reactive protein (CRP) Test has achieved CE
Marking. The LumiraDx CRP Test is a small, portable, fully
automated, microfluidic immunoassay test used for the quantitative
determination of C-reactive protein with results within four
minutes. The measurement of CRP provides important information for
the detection and evaluation of infection, and inflammation. In
patients with respiratory infection symptoms, especially suspected
pneumonia1, significantly high CRP suggests the need for
antibiotic treatment, whereas normal or low CRP levels suggest
patients have viral or self-limiting infection that does not
require antibiotics.
The LumiraDx CRP Test accurately measures direct fingerstick,
venous whole blood, and plasma samples within a range of 5.0 -
250.0 mg/L. The assay is run on the LumiraDx Platform, which can be
used at the patient side in primary and community care, patient
homes and in hospital emergency care settings providing fast,
reliable test results for timely decision making.
Clinicians can use the LumiraDx CRP test in the assessment of
infection, tissue injury, and inflammatory conditions. Insights
from the test can also provide valuable information to reduce
unnecessary antibiotic prescribing, in an overall effort to fight
antimicrobial resistance. In fact, while the consumption of
antibiotics in England declined
during the pandemic2, recent studies have
highlighted high rates of antibiotic prescribing among COVID-19
patients3 illustrating the unnecessary use of
antibiotics and fear that antibiotic-resistant infections may
return to pre-pandemic levels.2
"Antimicrobial resistance is a growing concern across the globe,
and if left unaddressed will lead to a serious public health
crisis. While the causes of antimicrobial resistance are complex,
growing evidence suggests that improving the clinical diagnosis of
respiratory infections in patients is a key component in tackling
unnecessary antibiotic prescribing rates," says Professor
Jonathan Cooke, visiting Professor
in the Department of Surgery and Cancer, Faculty of Medicine at
Imperial College London. "Having access to rapid CRP-POCT
diagnostic tools has been shown to support healthcare providers
when making prescribing decisions and helps improve the management
of respiratory infections."
Ron Zwanziger, LumiraDx Chairman and CEO explained, "The
addition of CRP onto the LumiraDx Platform will be critical this
respiratory season to provide clinicians with a variety of tools to
aid in the assessment of patients and their need for antibiotic
treatment. Including the assay on the LumiraDx platform along with
our COVID-19 and Flu A/B tests will enable clinicians to make
important treatment decisions at the point of care."
Shipments of the LumiraDx CRP Test will begin shortly. The
announcement comes on the heels of the company announcing the CE
Mark for the LumiraDx SARS-CoV-2 & Flu A/B Antigen
Test just last month.
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 LumiraDx CRP Test and LumiraDx
Platform. 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 regulatory approval or
clearance of tests; 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
Colleen.McMillen@lumiradx.com
References
- Guidelines for the management of adult lower respiratory tract
infections – Summary, Clinical Microbiology and Infection,
2011
- English surveillance programme
for antimicrobial utilisation and resistance (ESPAUR),
Report 2020 to 2021
- Westblade, LS et al. Bacterial Coinfections in Coronavirus
Disease 2019. Trends in Microbiology, 2021, Vol. 29, No. 10
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SOURCE LumiraDx