Boca BioSpecimen360 is here, a simpler way to source biospecimens.
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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.
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.
Client-focused, precise, rapid, and traceable results. Trust Boca Bio for your next project.
Access the platforms you need, including immunoassays, real-time PCR, Transcription-Mediated Amplification, microbiological phenotypic susceptibility, next-generation sequencing, and more.
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.
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.
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.
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
Diasorin Liaison XL
An assay validation study evaluates whether a test performs reliably for its intended purpose. Depending on the assay and regulatory pathway, the study may assess accuracy, precision, analytical sensitivity, analytical specificity, measuring range, interference, reproducibility, and other performance characteristics.
Boca Bio supports analytical and clinical assay validation, diagnostic assay validation, immunoassay validation, instrument-performance studies, biomarker testing, and regulatory-support studies. The final design depends on the assay, intended use, specimen type, platform, and regulatory strategy.
Yes. Boca Bio can combine retrospective inventory, custom prospective procurement, clinical-site access, central laboratory testing, data management, and biostorage to support validation studies requiring specific disease states, controls, matrices, or clinical annotations.
Boca Bio supports biospecimen procurement, clinical research, central laboratory testing, and data services relevant to companion diagnostic development. The required services should be scoped according to the biomarker, therapeutic program, assay platform, clinical-study design, and regulatory strategy.
