LONDON, Feb. 21, 2022 /PRNewswire/ -- LumiraDx (Nasdaq:
LMDX) announced today that its rapid COVID-19 molecular assay,
LumiraDx SARS-CoV-2 RNA STAR Complete, has been successfully
validated by Coronavirus Test Device Approvals (CTDA) and received
UK Medicines and Healthcare products Regulatory Agency (MHRA)
approval.
LumiraDx SARS-CoV-2 RNA STAR Complete, developed with
proprietary qSTAR technology, utilizes a single step direct method
for nucleic acid extraction and amplification on validated open
RT-PCR instruments, with results within 20 minutes. In clinical
studies, the assay demonstrated 95.4% positive agreement when
compared to another high sensitivity RT-PCR assay.
David Walton, Chief Commercial
Officer, LumiraDx states "Since the start of the pandemic, we have
been pleased to support the UK healthcare system with our LumiraDx
SARS-CoV-2 Antigen test, providing high sensitivity COVID-19
antigen testing in emergency departments, healthcare clinics,
pharmacies, and nursing homes. With CDTA and MHRA approvals of
LumiraDx SARS-CoV-2 RNA STAR Complete, we look forward to
partnering with our service partners to provide high throughput,
high sensitivity and high efficiency COVID-19 molecular testing.
With the capability to process samples up to ten times faster than
traditional RT-PCR methods, we are seeing broad customer demand for
testing at multiple settings including airports, events and other
public venues."
Earlier this month, LumiraDx also received UK CTDA and MHRA
approval for its SARS-CoV-2 Antigen Test.
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.
Media contact: Colleen McMillen,
colleen.mcmillen@lumiradx.com, +1.917.344.9360
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