QuidelOrtho Receives De Novo FDA Authorization for Sofia® 2 SARS Antigen+ FIA
March 08 2023 - 4:05PM
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 a De Novo
request from the U.S. Food and Drug Administration (FDA), allowing
the company to market 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. The test is intended
for prescription use only and can be used in point-of-care
settings.
The Sofia 2 SARS Antigen+ FIA is a lateral flow
immunofluorescent assay that is used with the Sofia 2 fluorescent
immunoassay analyzer intended for the qualitative detection of the
nucleocapsid protein antigen of SARS-CoV-2 in direct anterior nasal
swab specimens from individuals with signs and symptoms of upper
respiratory infection (i.e., symptomatic) when testing is started
within six days of symptom onset. The test is intended for use as
an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in
symptomatic individuals when tested at least twice over three days
with at least 48 hours between tests. The Sofia 2 SARS Antigen+ FIA
is intended for use by trained clinical laboratory personnel and
individuals trained in point-of-care settings and proficient in
performing tests using 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, we are pleased to again be
the first to receive De Novo FDA clearance for our Sofia 2 SARS
Antigen+ FIA,” said Douglas Bryant, president and CEO of
QuidelOrtho Corporation. “With this De Novo authorization, Sofia
becomes the predicate device upon which subsequent devices of the
same type and intended use will be compared. This designation is a
tribute to the incredible ingenuity, commitment to quality, and
cohesion of our entire QuidelOrtho team from R&D and regulatory
affairs, to design, manufacturing, labeling and packaging. It is a
spirit that sustained us through the darkest days of the pandemic
and will assure that our rapid testing technologies remain at the
forefront of prevention as COVID-19 transitions to its endemic
stage.”
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 prefilled 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) unites the power of
Quidel Corporation and Ortho Clinical Diagnostics behind a shared
mission of developing and manufacturing innovative technologies
that raise the performance of diagnostic testing and create better
patient outcomes across the entire healthcare continuum.
Ranked among the world’s largest in vitro diagnostics (IVD)
providers with more than 120 years of collective experience, we
combine industry-leading expertise in immunoassay and molecular
testing with a global footprint in clinical labs and transfusion
medicine.
Our company’s comprehensive product portfolio delivers accuracy,
speed, automation and access, providing critical information when
and where it is needed most. Inspired by a spirit of service,
QuidelOrtho is committed to enhancing the well-being of people
worldwide and happy in the knowledge we are making a difference.
For more information, please visit www.quidelortho.com.
Source: QuidelOrtho Corporation
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230308005731/en/
Media: media@Quidel.com
QuidelOrtho (NASDAQ:QDEL)
Historical Stock Chart
From Jun 2024 to Jul 2024
QuidelOrtho (NASDAQ:QDEL)
Historical Stock Chart
From Jul 2023 to Jul 2024