MedPath

QuidelOrtho's VITROS Syphilis Assay Receives FDA Approval to Combat Syphilis Epidemic

• QuidelOrtho's VITROS Syphilis Assay gains FDA approval, marking a significant step in addressing the rising syphilis 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 is also developing a next-generation RVP4+ assay, expected to be commercially available in 2025, to enhance its infectious disease testing portfolio. • The company focuses on improving operational efficiency and investing in new technologies, with plans to expand its diagnostic test menu and market reach.

QuidelOrtho, a San Diego-based diagnostic company, has received FDA clearance for its VITROS Syphilis Assay. This approval marks a crucial advancement in combating the syphilis 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 is designed to align with the Centers for Disease Control and Prevention (CDC)'s reverse testing algorithm for syphilis screening. According to Bryan Hanson, president of North American Commercial Operations at QuidelOrtho, 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 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+ 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 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 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 is exploring opportunities to add new tests to its menu, such as syphilis, to complement its existing herpes simplex virus and varicella-zoster virus (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.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Daré Bioscience Advances Sildenafil Cream for Female Sexual Arousal Disorder

Daré Bioscience is moving forward with Phase 3 trials for Sildenafil Cream 3.6% to treat Female Sexual Arousal Disorder (FSAD).
The planned Phase 3 study will assess the cream's efficacy over 12 weeks, focusing on arousal sensations and associated distress.

MVITRO's ORTIV Receives FDA Clearance for Needle-Free Blood Sampling

MVITRO's ORTIV, a laser-based device for painless blood sampling and glucose monitoring, has secured FDA 510(k) clearance, marking a significant advancement in diabetes management.
ORTIV utilizes micro-lasers to minimize skin damage and eliminate infection risks, offering real-time glucose readings via a dedicated app, addressing the stress of traditional blood sampling.

QuantalX's Delphi Stimulator Receives FDA Clearance for Advancing Brain Health Diagnosis

QuantalX has received FDA clearance for its Delphi stimulator, a novel device designed for direct brain health diagnosis at the point of care.
The Delphi-MD platform enables early detection of brain abnormalities across conditions like stroke, dementia, Parkinson's Disease, and traumatic brain injury.

Qyuns Therapeutics' Ustekinumab Biosimilar Approved in China for Psoriasis Treatment

Qyuns Therapeutics' ustekinumab biosimilar (SAILEXIN) has been approved by China's National Medical Products Administration.
The drug is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients.

FDA Accepts Telix Pharmaceuticals' Pixclara for Priority Review in Glioma Diagnosis

The FDA has accepted Telix Pharmaceuticals' New Drug Application for Pixclara, a diagnostic agent for gliomas, granting it priority review.
Pixclara aims to improve glioma diagnosis by overcoming limitations of conventional MRI, offering quicker and more reliable results.

SpineGuard's PsiFGuard Receives FDA Clearance for Sacroiliac Joint Fusion

SpineGuard's PsiFGuard, a smart drilling device for posterior sacroiliac fusion (PsiF), has received FDA 510(k) clearance for commercial use in the United States.
The PsiFGuard device utilizes SpineGuard's Dynamic Surgical Guidance (DSG®) technology to enhance the accuracy of implant placement in SI joint fusion procedures.

Roche's Subcutaneous Tecentriq Approved; Gilead's HIV Shot Shows Promise

The FDA approved Roche's Tecentriq Hybreza, the first checkpoint inhibitor available as a subcutaneous injection, offering a faster administration time of about seven minutes.
Gilead's twice-yearly lenacapavir HIV shot reduced infection risk by 96% in a Phase 3 trial, leading to halted trial and plans for regulatory filings and a potential 2025 launch.

FDA Approves Lymphir (denileukin diftitox-cxdl) for Relapsed/Refractory Cutaneous T-Cell Lymphoma

The FDA has approved Lymphir (denileukin diftitox-cxdl) for treating relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
Lymphir is a novel immunotherapy targeting the interleukin-2 (IL-2) receptor on malignant T-cells and Tregs, offering a new treatment option for CTCL patients.

Concept Medical's MagicTouch Sirolimus-Coated Balloon Receives FDA IDE Approval for Small Vessel Coronary Disease

Concept Medical's MagicTouch SCB receives FDA IDE approval for treating small vessel coronary disease, marking the third IDE approval for the device family.
The approval allows Concept Medical to begin a pivotal clinical study to assess the safety and efficacy of MagicTouch SCB in small vessel coronary disease.

FDA Approves Krystal Biotech's Vyjuvek, a Topical Gene Therapy for Dystrophic Epidermolysis Bullosa

The FDA has approved Vyjuvek, Krystal Biotech's topical gene therapy, marking the first treatment of its kind for dystrophic epidermolysis bullosa.
Vyjuvek is approved for patients aged six months and older with either recessive or dominant forms of dystrophic epidermolysis bullosa.

Reference News

[1]
QuidelOrtho Receives FDA Approval for STD Assay - San Diego Business Journal
sdbj.com · Sep 17, 2024

QuidelOrtho secures FDA clearance for Vitros Syphilis Assay, aiming to address the syphilis epidemic in the U.S. under n...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy