- The LumiraDx NT-proBNP and the LumiraDx D-Dimer tests are
currently the only quantitative direct fingerstick assays produced
for each test. Run on the highly portable LumiraDx Platform, they
are designed for near-patient testing with connected results in 12
minutes and 6 minutes, respectively
- The LumiraDx NT-proBNP test is a rapid microfluidic
immunofluorescence assay for the quantitative measurement of
NT-proBNP in human capillary, venous whole blood and plasma
specimens. It is intended to be used as an aid in the diagnosis of
congestive heart failure (CHF)
- With its new Exclusion Claim, the LumiraDx D-Dimer test may be
used at the point of care (POC), in conjunction with a clinical
pre-test probability assessment model, to allow clinicians to
rule out venous thromboembolism (VTE) in symptomatic patients
- Available on the same POC Platform as LumiraDx's high
sensitivity SARS-CoV-2 Antigen, Flu A/B, RSV, SARS-CoV-2 Antibody,
SARS-CoV-2 Antigen Pool, SARS-CoV-2 Ag Ultra and Ultra Pool as well
as HbA1c, INR, and CRP tests*
LONDON, June 2, 2022
/PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation
point of care diagnostics company, today announced it has expanded
its cardiovascular offering with a CE Mark for its new NT-proBNP
test to aid in the diagnosis of CHF and an updated CE Mark for
its D-Dimer test to now rule out venous thromboembolism (VTE) in
symptomatic patients. With these two additions, the LumiraDx
Platform can further support clinicians in quickly and accurately
assessing patient symptoms for both VTE and heart failure at the
point of care.
The LumiraDx NT-proBNP direct fingerstick assay monitors
levels of peptides elevated in the majority forms of heart
failure and provides results in twelve minutes from sample
application. It is designed for use in community-based healthcare
settings to quickly and accurately aid in the diagnosis of
individuals suspected of having congestive heart failure.
D-Dimer testing is widely accepted as the first step in the
management of patients suspected of VTE. The LumiraDx
D-Dimer test may now be used in conjunction with a clinical
pre-test probability assessment model to exclude deep vein
thrombosis (DVT) and pulmonary embolism (PE) disease in symptomatic
patients.1A prospective clinical study (EMBOL) conducted
in the UK and Germany with 618 symptomatic patients presenting
in the Emergency department and Ambulatory clinic settings,
demonstrated that the LumiraDx D-Dimer test has a strong
correlation with the laboratory reference method with 99.5%
negative predictive value at the 500 ug/L cut off, when used in
combination with a pretest probability score. EMBOL is the first
study to prospectively demonstrate the use of a quantitative
fingerstick D-Dimer test at POC to rule out VTE in symptomatic
patients, which has the opportunity to significantly improve
primary care assessment by physicians and also potentially reduce
the time of the patient's hospital visit, as well as follow up
testing.
Ron Zwanziger, LumiraDx's Chief Executive Officer
commented, "The new and updated CE Marks for our NT-proBNP and
D-Dimer tests represent an important advancement in cardiovascular
testing in the point of care space. Healthcare systems in
Europe and globally are looking to
shift care from centralized hospital settings to community
settings. Our new tests deliver results in minutes from an
easy-to-collect fingerstick sample, allowing fast and accurate
management of cardiovascular conditions by first responders,
primary care, urgent care, and the emergency department. Being
able to do this at the point of care can improve patient pathways,
reduce strains on health systems, specifically emergency
departments and lead to improved patient outcomes."
The LumiraDx D-Dimer test is commercially available across
Europe. The LumiraDx NT-proBNP
test is expected to begin commercialization later this year.
* Not all tests are available in all countries and
regions. For additional detail on product availability please
visit www.lumiradx.com.
- Rodger MA, Le Gal G, Wells P et al. Clinical decision rules and
D-Dimer in venous thromboembolism: current controversies and future
research priorities. Throm Res 2014; 134,4: 763-68
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 NT-proBNP and D-Dimer
tests, and the expected commercialization timeline for the LumiraDx
NT-proBNP 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; regulatory changes; the ability of
LumiraDx to maintain CE marking for its NT-proBNP and D-Dimer
tests; 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 in 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,
except as required by applicable law.
Media
Contact:
Colleen.McMillen@lumiradx.com
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SOURCE LumiraDx