Clinical Validation Testing Services
Clinical Validation Testing at Pangea Laboratory
CLIA/CAP
Laboratory
High Quality
Data
Short
Turnaround
Comprehensive
Bioinformatic
For industry and research needs, Pangea Laboratory is proud to offer flexible Next Generation Sequencing (NGS), Epigenetic, and PCR testing services in a CLIA-certified and CAP-accredited clinical laboratory environment, delivering your data in a fully customizable, easy-to-interpret analysis report. We offer a diverse portfolio of state-of-the-art technologies, which can be deployed to create custom testing solutions tailored to your requirements. Our end-to-end services start with sample collection and include comprehensive pre- and post-analysis support from our bioinformaticians and scientists.
Pangea Laboratory Offers Globally Trusted Testing Services
At our California-based CLIA-certified and CAP-accredited laboratory, we offer a wide range of custom molecular diagnostic testing solutions for both industry and research needs. Every step along the way, our workflows have been thoroughly tested and validated, to deliver high-quality data you can rely on.
Whether you are a Clinical Research Organization or a Biotech start-up, we can collaborate with you by providing cost-effective testing and data analysis solutions that will empower you to sequence and analyze the biological information that matters to you, more effectively.
Our testing services have been trusted by companies worldwide to meet their research objectives and more.
Our Testing Capabilities
We specialize in high-throughput sequencing, delivering precise and accurate insights rapidly and cost-effectively. Whatever your molecular diagnostic testing targets, we can design a solution that’s right for you.
All our services include sample collection, extraction, library prep, sequencing, and comprehensive bioinformatics analysis. Our control over our testing supply chain also ensures the availability of testing kits that allow for the safe collection of samples, including the inactivation and stabilization of pathogens.
• Epigenetic Analysis: Targeted Bisulfite Sequencing, Genome-Wide DNA Methylation Profiling using Next Generation Sequencing or Illumina EPIC 850k methylation arrays
• Gene Expression Analysis: RNA-Seq
• Microbiome Analysis: Metagenomic Sequencing, Species Level Resolution with 16s rRNA-Seq
• Real-Time PCR
• Nucleic Acid Purification: High yield and high purity DNA and RNA
Our Next Generation Sequencing (NGS) Data Analysis Services
Making sense of your data is easy with help from our dedicated bioinformatics team. Pangea Laboratory has a team of highly experienced bioinformatics specialists who can assist with all your data analysis needs, offering customizable deliverables, including easy-to-understand data visualization. The scope of the project can be tailored to your specific objectives, and our team of bioinformaticians will also be on hand to go over your results and uncover additional targeted insights.
Our Technology
Automation
Hamilton Microlab STAR
Kingfisher Flex
TECAN Fluent 1080
Alinity m
NGS
Mini-Seq
Nova-Seq
PCR
Bio-Rad PCR System
Applied Biosystem QuantStudio 7
Alinity m
Microarray
Illumina EpicArray
Cell Culture
DNA and RNA Extraction
Depending on your needs, we are equipped to add additional technology and design customized workflows to analyze your samples. Our research and development team is constantly innovating new tools and techniques to meet the challenge of evolving testing needs.
End to End Customized Testing Solutions
Every one of our analysis services can be fully customized to meet your needs by our dedicated team of scientists and researchers. During your consultation with our team, they will take the time to discover your goals, and work with you to set up the right workflow to meet your desired outcomes most efficiently. Post-sequencing, you will be able to securely access your raw data, as well as receive detailed analysis in reports prepared by our experienced bioinformatics scientists to help you delve deeper into your results.
Testing Workflow
1. Collection and transportation
2. Sample extraction
3. Library prep
5. Comprehensive bioinformatic analysis
6. Pre and Post analysis support – user-friendly reports and clinical interpretation services
Pangea Laboratory is a CLIA/CAP Accredited Facility
Per guidelines from the Centers for Medicare and Medicaid Services (CMS), Clinical Laboratory Improvement Amendment (CLIA) registration is necessary to certify the validity of NGS-based tests, measured by their accuracy, precision, analytical sensitivity, and specificity, as well as the reportable reference range or interval. Beyond this, the College of American Pathologists (CAP) also has specific guidelines to ensure compliance with high levels of standards, for both the wet lab and bioinformatics pipelines.
CLIA and CAP requirements for NGS are updated annually to keep up with the constantly improving NGS landscape, and Pangea Laboratory has maintained our high levels of quality assurance standards and stayed fully accredited since we first received our certification in 2017. We have fully validated workflows and standard operating procedures, even as we continually upgrade our instruments. You can also rest assured that we have stringent data storage processes to ensure data confidentiality.
