Advancing Global Diagnostics with Expanded Immunoassay Testing Solutions

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QuidelOrtho is strengthening its global immunoassay offering through a new partnership aimed at expanding assay availability beyond its existing VITROS diagnostic system portfolio

As laboratories worldwide move toward greater automation, consolidation, and comprehensive testing capabilities, diagnostic companies are increasingly expanding their immunoassay portfolios to meet evolving clinical and operational demands. Strategic collaborations are playing a key role in enabling broader test menus, scalable platforms, and improved access to specialized diagnostics across diverse healthcare settings. In this context, QuidelOrtho is strengthening its global immunoassay offering through a new partnership aimed at expanding assay availability beyond its existing VITROS diagnostic system portfolio. In this interview with MedTech Spectrum, Bryan Hanson, Executive Vice President of Global Portfolio Management and Marketing at QuidelOrtho, discusses how the collaboration will broaden testing capabilities, support laboratories across different care settings, and reinforce the company’s long-term strategy in global diagnostics markets.

What strategic gaps in your global immunoassay portfolio does this agreement aim to address, particularly in markets outside the United States?

At QuidelOrtho, we aim to advance the power of diagnostics by improving access to testing for communities worldwide. Each customer, in each region, may have different diagnostic testing demands and challenges. By collaborating to expand our global immunoassay portfolio for both routine and specialty testing, we’re helping to support labs of all sizes and across geographic locations. We believe this agreement helps to strengthen our ability to power labs at the heart of patient care, while offering operational and financial efficiencies.

This partnership adds more than 25 new assays not currently available on the VITROS system. How will this expanded menu enhance your competitiveness in full-menu tenders across Europe, Asia-Pacific, and emerging markets?

Expanding our menu by more than 25 assays significantly strengthens our position in full-menu tenders across Europe, Asia-Pacific and emerging markets. In many of these regions, the ability to offer a broad and comprehensive test portfolio is a critical requirement for participation.

Some of the assays we can offer as part of our expanded menu can support esoteric testing. These highly specialized, non-routine tests are critical for diagnosing rare and complex diseases. When combined with the VITROS™ portfolio, these assays enable more comprehensive testing, supporting clinicians in providing better patient care.

How do the newly accessed high-throughput and low-to-mid volume platforms complement QuidelOrtho’s existing installed base, and which laboratory segments are you primarily targeting?  

The purpose of this strategic supply agreement is to provide customers with greater flexibility and a broader range of solutions to meet their needs. In addition to our extensive diagnostic capabilities through our VITROS portfolio and automated solutions, customers can now rely on us to support a broader range of laboratory settings, from smaller labs needing critical access care tests to large, high-volume operations that require scalable capacity and both routine and specialty test menus. This is especially valuable for hospital networks, enabling both core labs and remote sites to access a broad, flexible range of testing capabilities.

How will this collaboration help deliver scalable solutions and cost efficiency without compromising assay quality or clinical performance?

The analyzers and assays included in this strategic supply agreement deliver high-quality analytical performance and are already supporting patient testing across global markets. Adding these solutions to our already broad VITROS menu helps us support the diverse needs of a wide range of laboratories. From key esoteric testing that helps complete specific disease-state diagnostics to improving cost efficiency by allowing labs to bring better testing solutions in-house, this agreement is designed to support the delivery of scalable, high-quality and cost-efficient solutions.

From a regulatory perspective, what challenges do you anticipate in rolling out these platforms across EMEA, Latin America, India, and China?

Regulatory pathways vary significantly across EMEA, Latin America, India and China, with differences in submission requirements, local clinical data expectations, labeling standards and post-market surveillance frameworks. Navigating these regional nuances while maintaining consistent quality and compliance standards is a key focus of our rollout strategy.

QuidelOrtho and Lifotronic have dedicated global and regional regulatory teams focused on delivering these key solutions to customers who need them efficiently, while accounting for region-specific regulatory requirements.

How does this partnership fit into QuidelOrtho’s long-term innovation roadmap as laboratories move toward greater consolidation and automation?

This strategic supply agreement supports our mission of advancing the power of diagnostics for a healthier future for all. By focusing on what our laboratory customers need across diverse care settings, laboratory sizes and geographic regions, we are expanding comprehensive disease-state testing while addressing increasing demands for operational efficiency, automation and consolidation. Together, these efforts strengthen our long-term innovation strategy in core growth markets.