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Excellence in Analytical and Clinical Assay Validation

Validate the accuracy and reliability of your novel assay in a world-class central laboratory with a trusted partner that gets you consistent results with fast turnaround times.

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You have the breakthroughs, we have the tools you need. Choose analytical and clinical assay validation with experts who drive science forward.

Select from over 25 in-house molecular and immunological analyzers and flexible testing options, or let us know your specifications and we’ll create a customized solution.

We collaborate with your team to design precision studies that meet your unique needs, align with global regulatory requirements, and safeguard the security, integrity, and traceability of your data results.

Here are some of our offerings:

Advanced chemistry and molecular testing

Diagnostic assay validation

Instrument performance

Biomarker identification, validation, and analysis

Immunoassay validation

Regulatory submission support studies

Clinical trial support services 

Not seeing what you need? Please reach out to our team of experts.

CLIA-certified and CAP-accredited

Diverse instrumentation for IVD and CDx validation

Secure, scalable LIMS

What our partners say about us

  • "We found an FDA-recommended supplier who can provide biospecimens for validation - Boca Biolistics. The fact is Boca has complete documents to eliminate doubts from regulatory agencies and researchers"

    彭至正 Chris Peng

    業務一課 Deputy Manager, 禮文股份有限公司 Mitek Lab Co., LTD

  • “I bought some samples from Boca. They actually have Zika-positive samples that we actually use for our testing.”

    Art Cowes

    Senior Manager of Clinical Operations and Data Management, Arete Biosciences

Demonstrate the accuracy and reliability of your novel assays with our world-class analytical and clinical assay validation services

Client-focused, precise, rapid, and traceable results. Trust Boca Bio for your next project.

State-Of-The-Art Technology

Access the platforms you need, including immunoassays, real-time PCR, Transcription-Mediated Amplification, microbiological phenotypic susceptibility, next-generation sequencing, and more.

Dedicated Project Management

Get a single point of contact dedicated to ensuring all of your study specifications are met. Our team maintains transparent and consistent communication at every step to ensure your success.

Customized Reporting

Receive your validation results in a comprehensive data package for your team or ask us about our direct client portal to integrate your existing LIS/EHR/EMR.

Beyond Validation

Combine our biospecimen procurement and clinical research services with our validation testing to maintain a single chain of custody to accelerate your timelines and safeguard your data to innovate faster.

Explore our advanced instrumentation — essential tools for your research success

Contact Us to Learn More

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Frequently Asked Questions

The laboratory employs several state-of-the-art technology platforms:

Immunoassays: Detect and measure substances using antibodies or antigens.

Real-Time PCR: Amplifies DNA sequences to detect DNA presence and quantity.

DNA Hybridization: Assesses genetic similarity by encouraging complementary DNA strands to bind.

Transcription Mediated Amplification: Detects RNA and DNA in various samples, useful in rapid pathogen detection.

Microbiological Phenotypic Susceptibility: Analyzes how microorganisms react to antimicrobial agents, crucial for studying drug resistance.

Next Generation Sequencing: Provides comprehensive genetic sequencing to analyze DNA and RNA variants and mutations for biomarker identification and more.*
* Outsource to one of our many partner labs.

The central laboratory offers a comprehensive test menu that includes advanced chemistry and molecular testing for diagnostic validation and biomarker analysis, with the flexibility to accommodate specialized testing requests to meet client project requirements​​.

Yes, Boca Bio prides itself on our flexibility, responsiveness, and ability to work with our clients to deliver customized testing solutions to meet unique client requirements now and as technologies emerge.

We offer an array of specialized assays and instruments, including method comparison studies, precision studies, and validation studies, each designed to support the development and optimization of diagnostic tests and methodologies. Our comprehensive services ensure the reliability, accuracy, and clinical relevance of your research and diagnostic tools, from early development through market approval.

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Drive your science forward today with our analytical and clinical assay validation services.

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