QuidelOrtho's VITROS Syphilis Assay Receives FDA Approval to Combat Syphilis Epidemic
Key Insights
QuidelOrtho (search)'s VITROS Syphilis Assay (search) gains FDA approval, marking a significant step in addressing the rising syphilis (search) rates in the United States.
The new assay improves laboratory efficiency by aligning with the CDC's reverse testing algorithm, reducing the need for external referrals and lowering costs.
QuidelOrtho (search) is also developing a next-generation RVP4+ (search) assay, expected to be commercially available in 2025, to enhance its infectious disease testing portfolio.
QuidelOrtho (search), a San Diego-based diagnostic company, has received FDA clearance for its VITROS Syphilis Assay (search). This approval marks a crucial advancement in combating the syphilis (search) epidemic in the United States. The company anticipates that this new assay will significantly improve the efficiency and cost-effectiveness of syphilis screening.
Assay Benefits and Efficiency
The VITROS Syphilis Assay (search) is designed to align with the Centers for Disease Control and Prevention (CDC)'s reverse testing algorithm for syphilis (search) screening. According to Bryan Hanson, president of North American Commercial Operations at QuidelOrtho (search), this alignment not only improves laboratory efficiency but also reduces costs by enabling earlier disease detection and minimizing the need to send tests to outside labs.
Broader Diagnostic Portfolio
QuidelOrtho (search) develops and manufactures a wide range of diagnostic products aimed at helping healthcare professionals evaluate patients for various infectious diseases and chronic conditions. The company is also working on a next-generation RVP4+ (search) assay, which is expected to be commercially available in 2025. Data collected over nine months for the four viruses targeted by the RVP4+ test has shown promising results, according to the company.
Strategic Focus and Leadership
In May 2024, QuidelOrtho (search) appointed Brian Blaser as its new CEO. Blaser, formerly of Abbott, is focused on improving the company's overall business efficiency through initiatives in procurement, supply chain, manufacturing quality, and IT. According to Blaser, the company is committed to challenging every aspect of the business to improve performance while investing in future growth.
Company Overview
QuidelOrtho (search) was formed in 2022 following Quidel's $6 billion acquisition of Ortho Clinical Diagnostics Holdings. Headquartered in San Diego, the company has approximately 7,100 employees worldwide, with 4,200 based in the United States. The company is focused on enhancing its local production facilities, investing in new technologies, and expanding into new markets.
Future Outlook
QuidelOrtho (search) is exploring opportunities to add new tests to its menu, such as syphilis (search), to complement its existing herpes simplex virus (search) and varicella-zoster virus (search) (HSV/VZV) assay on its Savanna Real-Time PCR Testing Platform. These additions are expected to address critical needs and potentially create new market opportunities for the company.