Custom Development
SpeeDx delivers end-to-end custom molecular diagnostic development services backed by 15+ years of molecular diagnostics expertise and 100+ granted patents. Our integrated approach combines proprietary multiplexing technologies with comprehensive development, regulatory, and manufacturing capabilities.
Unlike competitors requiring multiple vendors, SpeeDx provides a single-source solution from initial feasibility through commercial readiness. Our experienced team has successfully developed 50+ diagnostic products and partnered with industry leaders to bring innovative tests to market faster and more cost-effectively.
Does your laboratory want to develop custom assays to differentiate your offering? Whether you need a completely novel assay, want to enhance existing tests with multiplexing capabilities, or require rapid response to emerging pathogens, SpeeDx has the technology, development and regulatory expertise, and track record to deliver. Our flexible engagement models can be tailored to your needs, so contact us today to turn your ideas into reality.
We specialize in complex multiplexing challenges that other providers cannot solve, leveraging our unique PlexPCR®, PlexPrime®, PlexPlus®, and InSignia® technologies to create best-in-class testing solutions based on your specifications and commercial requirements.
Complete Assay Development Expertise
for Laboratories
Proven Expertise
Infectious Disease
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STI panels with resistance markers
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Respiratory multiplex panels
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Gastrointestinal pathogen detection
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Emerging pathogen rapid response
Antimicrobial Resistance
Resistance gene detection
Phenotypic susceptibility prediction
Treatment guidance markers
Surveillance applications
Women's Health
Comprehensive STI screening
Pregnancy-related infections
With 15+ years of molecular multiplexing innovation and 100+ patents, SpeeDx can tailor solutions to your needs. From initial assay design through regulatory approval and commercial manufacturing, we've successfully delivered solutions for partners globally across every stage of the development journey.
Leaders in PCR Multiplexing
SpeeDx technology has been used for molecular diagnostics across 100+ laboratories in 30+ countries. Our ResistancePlus® and PlexPCR® assays process hundreds of thousands of samples annually, while providing cost-effective solutions for laboratories.
Proven at Scale
The SpeeDx R&D and Innovations development teams are highly knowledgeable and skilled assay developers. These experts love the challenge of a new project and apply a rigorous, hands-on approach to find the best solution to meet your needs.
Experienced Developers
Where competitors have lengthy timelines for multiplex assay development, our proprietary PlexPrime® and PlexZyme® technologies enable streamlined development cycles from concept through to validated assays. Along with our scale-up manufacturing expertise, we have your needs covered.
Rapid Development Timelines
Our team has navigated compliance across global regulatory frameworks for multiple product lines. We deliver technical validation packages under our ISO-13485 compliant frameworks for seamless integration into your regulatory dossiers.
Regulatory Expertise You Can Trust
Whether you need custom diagnostics or research assays, tests developed for your preferred instrumentation, or co-development of novel assays, we structure partnerships around your strategic objectives and commercial timelines.
Flexible Partnership Models
Why Partner with SpeeDx?
Benefit from the powerful PCR technologies and product development expertise at SpeeDx and enjoy a consultative approach to assay design. Each partnership model is unique—tailored to your strategic goals, risk tolerance, and commercialization plans—creating mutual value and long-term competitive advantages.
Discovery & Design
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Requirements gathering
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Feasibility assessment
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Project planning
Development & Optimization
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Assay development
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Multiplexing optimization
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Workflow/instrumentation integration
Validation & Verification
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Analytical testing
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Clinical testing
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Performance validation
Commercial readiness
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Regulatory submission
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Manufacturing scale-up
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Implementation & ongoing technical support
Custom Development Process
Our proven four-stage development framework ensures predictable timelines, controlled costs, and successful outcomes. Unlike traditional development approaches that can take years, SpeeDx accelerate timelines through proven multiplexing expertise and proprietary technologies.
Each project begins with a thorough discovery phase where we assess technical feasibility, define clinical requirements, and establish clear success criteria. Our experienced team then executes development with regular milestone reviews, ensuring you maintain full visibility and control throughout the process.
Our flexible engagement models accommodate your specific needs, whether you require complete turnkey development or targeted support for specific development stages.
Ready to Transform Your Diagnostic Capabilities?
Discover how SpeeDx's innovative multiplexing technology can enhance your laboratory efficiency and diagnostic capacity.