QuidelOrtho Receives CLIA Waiver for Sofia® 2 SARS Antigen+ FIA
September 21 2023 - 3:05PM
Business Wire
QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global
provider of innovative in vitro diagnostic technologies designed
for point-of-care settings, clinical labs and transfusion medicine,
announced today that it has been granted CLIA Waiver from the U.S.
Food and Drug Administration (FDA), applying to its new Sofia® 2
SARS Antigen+ FIA. The Sofia 2 SARS Antigen+ FIA is the first rapid
antigen test that detects COVID-19 to be awarded FDA market
clearance through the FDA’s De Novo process and is now the first
rapid antigen test also to receive CLIA waiver. The test is
intended for prescription use only and can be used in CLIA-waived
point-of-care settings.
With the CLIA waiver, the Sofia 2 SARS Antigen+ FIA is deemed to
be so simple and at such low risk of error that it no longer
requires administration by trained clinical laboratory personnel,
opening broader use in virtually any point-of-care setting equipped
with Sofia 2 instruments.
“As the first company to introduce a rapid antigen test for
COVID-19 when the FDA granted Emergency Use Authorization for the
Sofia SARS Antigen FIA in May of 2020, and the first to receive De
Novo FDA clearance for our Sofia 2 SARS Antigen+ FIA, it is
gratifying to also be the first to receive a full CLIA waiver for
our Sofia 2 SARS Antigen+ FIA,” said Douglas Bryant, President and
Chief Executive Officer of QuidelOrtho. “In the world of in vitro
diagnostics, this qualifies as a trifecta of innovation,
advancement and accessibility. This CLIA waiver is further proof of
QuidelOrtho’s commitment to product efficacy, ease and ergonomics
that help customers reduce costs and speed workflows, ultimately
delivering better patient care.”
The Sofia 2 analyzer utilizes QuidelOrtho’s proprietary
fluorescent chemistry design, intuitive graphical user interface,
and optics system to provide an accurate, objective and automated
result in just 10 minutes, a 33% reduction from the breakthrough
15-minute processing time achieved in the first iterations of the
Sofia SARS Antigen FIA assay. The Sofia 2 system also comes
connected to Virena®, QuidelOrtho’s data management system, which
provides aggregated, de-identified testing and surveillance data in
near real time.
The enhanced Sofia 2 SARS Antigen+ FIA Test kit includes other
upgraded features, such as pre-filled reagent vials, improved
ergonomic sample extraction and a dropper design for easy
dispensing of patient samples into the test cassette sample well.
The Sofia 2 instrument also offers two distinct workflows.
Depending upon the user’s preferred operational method, Sofia 2
SARS Antigen+ FIA test cartridges are either placed directly inside
Sofia 2 for automatically timed test development and results read
(WALK AWAY Mode), or test cartridges may be placed on the counter
or benchtop for a manually timed test development and then placed
into Sofia 2 for immediate results read (READ NOW Mode), which
allows users to markedly increase testing throughputs per hour.
Results are for the identification of the SARS-CoV-2
nucleocapsid protein antigen, which is generally detectable in
upper respiratory specimens during the acute phase of infection.
Positive results indicate the presence of viral antigens of
SARS-CoV-2, but clinical correlation with patient history and other
diagnostic information is necessary to determine infection status.
Positive results do not rule out bacterial infection or
co-infection with other viruses, as the agent detected may not be
the definite cause of disease.
A negative test is presumptive, and it is recommended these
results be confirmed by a molecular SARS-CoV-2 assay. Negative
results do not preclude SARS-CoV-2 infection and should not be used
as the sole basis for treatment or patient management
decisions.
About QuidelOrtho Corporation
QuidelOrtho Corporation (Nasdaq: QDEL) is a world leader in in
vitro diagnostics, developing and manufacturing intelligent
solutions that transform data into understanding and action for
more people in more places every day.
Offering industry-leading expertise in immunoassay and molecular
testing, clinical chemistry and transfusion medicine, bringing
fast, accurate and reliable diagnostics when and where they are
needed – from home to hospital, lab to clinic. So that patients,
clinicians and health officials can spot trends sooner, respond
quicker and chart the course ahead with accuracy and
confidence.
Building upon its 80-year legacy of groundbreaking innovation,
QuidelOrtho continues to partner with customers across the
healthcare continuum and around the globe to forge a new diagnostic
frontier. One where insights and solutions know no bounds,
expertise seamlessly connects and a more informed path is
illuminated for each of us.
QuidelOrtho is transforming the power of diagnostics into a
healthier future for all.
For more information, please visit www.quidelortho.com.
Source: QuidelOrtho Corporation
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