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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