VITROS® Syphilis Assay Now Available on VITROS 3600 Immunodiagnostic System, VITROS 5600 and VITROS XT 7600 Integrated Systems in the U.S.
August 29 2024 - 7:00AM
Business Wire
QuidelOrtho Receives FDA 510(k) Clearance
for its VITROS Syphilis Assay
QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”) has
received U.S. Food and Drug Administration (“FDA”) 510(k) clearance
for its VITROS syphilis assay as part of its menu, strengthening
QuidelOrtho’s position as a leader in infectious disease testing.
Using the automated VITROS systems, this assay is intended for the
qualitative determination of total (IgG and IgM) antibodies to
Treponema pallidum (TP)-specific antigens in human serum and plasma
using the automated VITROS 3600, 5600 and XT 7600 systems. The
presence of antibodies to TP-specific antigens, in conjunction with
non-treponemal laboratory tests and clinical findings may aid in
the diagnosis of syphilis infection. The VITROS syphilis assay is
not intended for blood and tissue donor screening. With the
addition of the U.S., the VITROS syphilis assay is now available
globally where QuidelOrtho products are available.
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VITROS® XT 7600 Integrated System (Photo:
Business Wire)
QuidelOrtho’s infectious disease test portfolio spans the
healthcare continuum from point-of-care settings to high-throughput
laboratories and is critical in addressing the growing syphilis
epidemic in the U.S. With over 176,000 new cases of syphilis
reported annually, a 36% increase in the prevalence of primary and
secondary syphilis since 2021, the need for comprehensive and
accessible testing solutions has never been greater.
“As an in-demand assay for a common sexually transmitted
infection (‘STI’), we are pleased to offer the VITROS syphilis
assay, bolstering QuidelOrtho’s infectious disease test portfolio
in the U.S.,” said Bryan Hanson, Senior Vice President, President
North American Commercial Operations at QuidelOrtho. “Not only does
this important assay improve laboratory efficiency by allowing labs
to follow the CDC’s reverse testing algorithm for syphilis
screening, it also reduces costs by providing earlier disease
detection, thereby reducing the need to refer tests to outside
labs.”
This expansion into the U.S. market aims to provide timely and
accurate diagnosis, crucial for effective treatment and control of
the disease.
“With an increased national incidence of syphilis and other
STIs, having a quick and easy way to test in various healthcare
settings is essential,” said Lily Li, Senior Director, Medical
Scientific & Clinical Affairs, QuidelOrtho. “The CDC Morbidity
and Mortality Weekly Report, updated in February 2024, recommends
that both nontreponemal and treponemal serologic tests be used in
conjunction to aid in the diagnosis of syphilis.”
QuidelOrtho continues to expand its menu for infectious disease
testing and beyond to help our customers provide the highest level
of patient care.
Sources: CDC. Syphilis Statistics 2022. Accessed June 27, 2024.
https://www.cdc.gov/std/statistics/2022/overview.htm#Syphilis. CNN.
Maternal Syphilis Rates Surge. Accessed June 27, 2024.
https://www.cnn.com/2024/02/13/health/maternal-syphilis-rates-surge-infant-risk/index.html#:~:text=That%27s%20about%201%20maternal%20syphilis,and%20infant%20deaths%20in%202022.
CDC. Media Release on STI Rates. Accessed June 27, 2024.
https://www.cdc.gov/media/releases/2023/s0411-sti.html.
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 many years 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 advancing diagnostics to power a healthier
future.
For more information, please visit www.quidelortho.com. Source:
QuidelOrtho Corporation
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version on businesswire.com: https://www.businesswire.com/news/home/20240829122353/en/
Investor Contact: Juliet Cunningham Vice President, Investor
Relations IR@QuidelOrtho.com
Media Contact: D. Nikki Wheeler Senior Director, Corporate
Communications media@QuidelOrtho.com
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