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Analytical Method Comparison Studies Made Easy

Advance your diagnostics by using the right method comparison studies from the beginning.

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Go beyond the standard test menu for your specific IVD studies and assays

Share your timeline, specifications, and analyte testing needs. Your dedicated project manager will consult with you to design a study that adequately compares methods, protocols, and required controls to deliver statistically significant results​.

We collaborate with your researchers to customize the testing menu to meet your needs. You can use our current range of molecular and immunoassay testing platforms or we have the flexibility to onboard your assay or your competitor’s assays as needed​​.

Our white-glove approach goes beyond testing to data management and reporting. You can trust your data is safe and secure. Our rigorous QC processes, industry-leading LIMS, and ability to interface with your existing LIS/EHR/EMR guarantee your data integrity is secure and easily accessible for your analysis.

Diverse instrumentation and assays

Secure and reliable data management

CLIA-certified and CAP-accredited central laboratory

Partners in progress: What our clients say

  • "We use Boca for their diagnostic testing for our comparator assays. Boca had a test that wasn't readily or easily available with my established contacts. They are very easy to work with. Very flexible, very responsive"

    Keith Shimizu

    Director of Clinical Research, Sekisui Diagnostics

  • “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

Accelerate your assay submissions with customizable analytical method comparison studies from discovery to approval

Take advantage of our state-of-the-art, high-efficiency central laboratory and project team that are method comparison experts. We offer a full end-to-end suite of services. Accelerate your research with Boca Bio. Team up with us to achieve your success.

Rapid turnaround

Get method comparison study results fast while maintaining high standards of quality and accuracy.

Customized Reporting

Access data through our portal and receive data in your format of choice, whether it’s raw data, summarized reports, or specific file types needed for regulatory submissions.

Securing Quality Samples

Let us procure your biospecimens to get high-quality and consistent samples that meet your study criteria and enable valid comparisons.

Dedicated Project Management

Partner with our experts experienced with global regulatory bodies to ensure your studies and data management meet all necessary compliance standards.

Explore our advanced instrumentation — essential tools for your research success

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Frequently asked questions

Boca Bio’s central laboratory conducts various types of method comparison and reference studies to support clients in the clinical and diagnostic industries. Here is a list of some typical studies and reference services offered:

Diagnostic assay validation

Instrument performance

Biomarker identification, validation, and analysis

Advanced chemistry and molecular testing

Immunoassay validation

Comparative testing across multiple modalities

Regulatory submission support studies

In-vitro diagnostics (IVD) development

Companion diagnostic (CDx) development

Clinical trial support services

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.

Clients work with a dedicated project manager who ensures that all study aspects are conducted according to the client's specifications. This single point of contact maintains clear and consistent communication, manages the project timeline, and resolves any challenges that may arise during the study​​.

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Drive your science forward with our method comparison studies

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