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Yes. Metabolon’s Data Governance Program was established to support Metabolon’s commitment to protecting the personal data we receive or collect to prevent misuse and unauthorized access and to complying with applicable data security and privacy laws and regulations. The Data Governance Program establishes risk-based safeguards that protect information while not impeding its appropriate use. Metabolon’s Information Security Officer and Data Privacy Officer, together with Metabolon’s Data Governance Steering Committee, are responsible for developing, maintaining and implementing the Data Governance Program in support of these program objectives.

Metabolon complies with regulatory mandates for handling personal data including the Health Insurance Portability Accountability Act (HIPAA), General Data Protection Regulation (GDPR), and California Consumer Privacy Act (CCPA). Metabolon has implemented a comprehensive information security program based on the NIST Special Publication 800-53 Revision 4 that combines policies and procedures with physical and logical security controls.

Microbiome SmartPanel data sets are exportable to industry standard formats for easy integration into many multi-omics software packages. If you prefer for Metabolon to assist in this analysis, we offer global assay options with customized support that could include multi-omics analysis.

Once your data is downloaded, you may share, store or manipulate it using statistical, multi-omic or other bioinformatic tools.

You can download your study results data by accessing the Data & Integration tab and using the data export tool.

Read about our Experimental Procedures here.

Read about our Statistical Methods and Terminology here.

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Yes. Metabolon’s Data Governance Program was established to support Metabolon’s commitment to protecting the personal data we receive or collect to prevent misuse and unauthorized access and to complying with applicable data security and privacy laws and regulations. The Data Governance Program establishes risk-based safeguards that protect information while not impeding its appropriate use. Metabolon’s Information Security Officer and Data Privacy Officer, together with Metabolon’s Data Governance Steering Committee, are responsible for developing, maintaining and implementing the Data Governance Program in support of these program objectives.

Metabolon complies with regulatory mandates for handling personal data including the Health Insurance Portability Accountability Act (HIPAA), General Data Protection Regulation (GDPR), and California Consumer Privacy Act (CCPA). Metabolon has implemented a comprehensive information security program based on the NIST Special Publication 800-53 Revision 4 that combines policies and procedures with physical and logical security controls.

Metabolon is ISO 9001:2015 certified for analytical and diagnostic testing of all biological samples. ISO 9001:2015 outlines specific Quality Management System requirements with a strong focus on ensuring consistent and efficient processes, customer focus and satisfaction, and continual improvement. Metabolon adheres to additional regulations or standards when performing specific types of testing:

Clinical Testing on Human Specimens: Metabolon adheres to the Clinical Laboratory Improvement Amendments (CLIA) regulations (42 CFR Part 493) when performing clinical testing on human specimens for the purpose of diagnosis, prevention, or treatment. Metabolon is also accredited by the College of American Pathology (CAP), which ensures that the laboratory does not only meet but also exceeds CLIA requirements. Metabolon possesses clinical laboratory licensures or permits from several states such as California, Maryland, Pennsylvania, and Rhode Island to perform clinical testing under CLIA. Metabolon holds a permit from New York State to perform specific tests under CLIA.

Our Certificates:

If you need a certificate for a specific state, you may talk with your Metabolon client success team.

GCP/GCLP Testing: Metabolon has the capability to offer bioanalytical testing for targeted assays that adhere to GCP and GCLP quality standards.

Data Security and Data Privacy: Metabolon complies with federal, state, and international regulatory mandates for handling personal data including the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160, 162, and 164), General Data Protection Regulation (GDPR) (EU 2016/679) and California Consumer Privacy Act (CCPA). Metabolon has implemented a comprehensive information security program based on the NIST Special Publication 800-53 Revision 4 that combines policies and procedures with physical and logical security controls. Metabolon’s Information Security Officer and Data Privacy Officer, together with Metabolon’s Data Governance Steering Committee, are responsible for developing, maintaining and implementing the Data Governance Program in support of these program objectives.

Bacterial/host origin groupings are based on our internal knowledge base and represent the most common origin of these metabolites. Because these metabolites are often produced by both bacteria and the host, our groupings can only represent a general picture and may not be definitive.

Our team of experts in discovery and translational science combined our institutional knowledge base with a review of external literature to identify these 13 pathways with special relevance to the microbiome.  If you desire the most comprehensive picture of host/microbiobe interactions, you can run our full global study which includes over 5,500+ metabolites and coverage of 70+ pathways.

Metabolon conducted an extensive process to curate this unique list of metabolites and small molecules for our Microbiome SmartPanel.  We reviewed internal studies from over 20 years of work as well as published studies in the field to select a panel of metabolites that is biologically relevant for study the microbiome.  The metabolites have been detected with great frequency in our studies and give a robust picture of the impact on 13 pathways with strong microbiome relevance.

Tiers, or levels, ranging from 1 to 5 are commonly used to convey metabolite identification confidence. Tiers refer to the level of detail for each metabolite, and thus the assigned confidence for accurate identification. It is not until the appropriate level of detail is reached in Tier 1 that definitive compound identification based on multiple orthogonal measurements and comparison to data from an authentic standard can be achieved. Therefore, Tier 1 identifications represent the highest level of confidence in the annotation. Tiers 2 through 5, on the other hand, represent decreasing levels of confidence based on less rigorous or more ambiguous criteria.

While most metabolomic practitioners operate primarily with annotations that only meet the standards of Tiers 3-5, Metabolon’s Precision Metabolomics™ workflow is uniquely designed to deliver Tier 1-2 identifications for detected metabolites. This unique level of confidence in the annotations is made possible by Metabolon’s use of a chemocentric approach to metabolomics that uniquely detects metabolite features and matches them against Metabolon’s vast in-house library. Metabolon built this library through the analysis of >5,000 authentic standards run in-house using our methods and instruments. This approach to untargeted metabolomics means that all metabolite annotations meet the stringent criteria required for a Tier 1 or 2 identification.

Our method stands in stark contrast to the more traditional metabolomics workflow in which the individual ion features, the instrument signal from a mass spectrometer, undergo statistical analysis. Only the most significant are subjected to an attempt at a high Tier identification. Metabolon’s approach leverages this vast library to ensure accurate annotation of not only the metabolites, which show statistically significant changes in a study, but also those which remain unchanged, and therefore add crucial insight into the underlying biology.

If you want the highest biological insights from your metabolomics study, you need the highest quality metabolite annotation. Our integrated bioinformatics solution makes it possible to efficiently and accurately mine the world’s most biologically relevant, validated metabolomics compound library for every study to ensure consistently reliable results every time. Learn more about Metabolon’s Tier 1 identification workflow.

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These samples have been validated to have a high fill rate for the chosen metabolites and require less curation time, enabling us to offer a faster turnaround time and lower pricing than our global assay offerings.

Yes. Metabolon has the expertise and knowledge to partner with clients to develop Diagnostic (Dx) tests, including Companion Diagnostics (CDx). Metabolon collaborates with companies to develop and implement an appropriate regulatory strategy and ensures study integrity and high-quality data generation through all phases of the product development process. Metabolon employs a rigorous design control process to de-risk development and ensure that the Dx test meets all pre-established requirements.

Metabolon has the flexibility to develop and validate quantitative metabolomic diagnostic tests according to the stringent requirements of either the FDA Bioanalytical Method Validation Guidance or CLIA regulations and CAP standards, depending on the purpose of the Dx test. Following analytical validation of the diagnostic test, Metabolon has the capability to perform bioanalytical testing under GCP/GCLP or CLIA requirements to support clinical validation of the Dx or CDx.

Yes. All GCP/GCLP targeted assays are developed and validated according to the rigorous requirements outlined in the FDA Bioanalytical Method Validation Guidance (2018). Metabolon also has the capability to validate GCP/GCLP targeted assays to the standards defined in the EMA Guideline on Bioanalytical Method Validation (2011).

Yes. Metabolon offers quantitative biomarker analyses of specific metabolites (also referred to as a targeted assay) that adhere to GCP and GCLP standards when this quality standard is required for clinical trials. All GCP/GCLP targeted assays are validated according to the FDA Bioanalytical Method Validation Guidance (2018) or the EMA Guidance for Bioanalytical Method Validation (2011). All other bioanalytical testing offered by Metabolon adheres to ISO 9001:2015 Quality Management Standards. ISO 9001:2015 outlines specific Quality Management System requirements with a strong focus on ensuring consistent and efficient processes, customer focus and satisfaction, and continual improvement.

Feces samples require additional handling to process due to the additional sample preparation time for our platform.

If your project meets our standard SmartPanel requirements (sample size, volumes, etc.), most fecal studies can be completed within 8 weeks, and most serum/plasma studies can be completed in 6 weeks or less.

Microbiome SmartPanel data sets are exportable to industry standard formats for easy integration into many multi-omics software packages. If you prefer for Metabolon to assist in this analysis, we offer global assay options with customized support that could include multi-omics analysis.

Customized reports are not available with the Microbiome SmartPanel. However we offer other global assay solutions which can be customized to include the level of interpretation and special reporting that your project requires.

Yes. If you require absolute quantification, you can choose from our full library of Targeted Assay solutions.

This panel was designed to cover the most relevant biological pathways for microbiome study with reduced turnaround time and cost versus our global panels.  If your study requires additional metabolites, you will need to choose from one of our global platform offerings (mData, mSelect, mVision).

These samples have been validated to have a high fill rate for the chosen metabolites and require less curation time, enabling us to offer a faster turnaround time and lower pricing than our global assay offerings.

Yes. Metabolon has the expertise and knowledge to partner with clients to develop Diagnostic (Dx) tests, including Companion Diagnostics (CDx). Metabolon collaborates with companies to develop and implement an appropriate regulatory strategy and ensures study integrity and high-quality data generation through all phases of the product development process. Metabolon employs a rigorous design control process to de-risk development and ensure that the Dx test meets all pre-established requirements.

Metabolon has the flexibility to develop and validate quantitative metabolomic diagnostic tests according to the stringent requirements of either the FDA Bioanalytical Method Validation Guidance or CLIA regulations and CAP standards, depending on the purpose of the Dx test. Following analytical validation of the diagnostic test, Metabolon has the capability to perform bioanalytical testing under GCP/GCLP or CLIA requirements to support clinical validation of the Dx or CDx.

Metabolon is ISO 9001:2015 certified for analytical and diagnostic testing of all biological samples. ISO 9001:2015 outlines specific Quality Management System requirements with a strong focus on ensuring consistent and efficient processes, customer focus and satisfaction, and continual improvement. Metabolon adheres to additional regulations or standards when performing specific types of testing:

Clinical Testing on Human Specimens: Metabolon adheres to the Clinical Laboratory Improvement Amendments (CLIA) regulations (42 CFR Part 493) when performing clinical testing on human specimens for the purpose of diagnosis, prevention, or treatment. Metabolon is also accredited by the College of American Pathology (CAP), which ensures that the laboratory does not only meet but also exceeds CLIA requirements. Metabolon possesses clinical laboratory licensures or permits from several states such as California, Maryland, Pennsylvania, and Rhode Island to perform clinical testing under CLIA. Metabolon holds a permit from New York State to perform specific tests under CLIA.

Our Certificates:

If you need a certificate for a specific state, you may talk with your Metabolon client success team.

GCP/GCLP Testing: Metabolon has the capability to offer bioanalytical testing for targeted assays that adhere to GCP and GCLP quality standards.

Data Security and Data Privacy: Metabolon complies with federal, state, and international regulatory mandates for handling personal data including the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160, 162, and 164), General Data Protection Regulation (GDPR) (EU 2016/679) and California Consumer Privacy Act (CCPA). Metabolon has implemented a comprehensive information security program based on the NIST Special Publication 800-53 Revision 4 that combines policies and procedures with physical and logical security controls. Metabolon’s Information Security Officer and Data Privacy Officer, together with Metabolon’s Data Governance Steering Committee, are responsible for developing, maintaining and implementing the Data Governance Program in support of these program objectives.

Yes. All GCP/GCLP targeted assays are developed and validated according to the rigorous requirements outlined in the FDA Bioanalytical Method Validation Guidance (2018). Metabolon also has the capability to validate GCP/GCLP targeted assays to the standards defined in the EMA Guideline on Bioanalytical Method Validation (2011).

Yes. Metabolon offers quantitative biomarker analyses of specific metabolites (also referred to as a targeted assay) that adhere to GCP and GCLP standards when this quality standard is required for clinical trials. All GCP/GCLP targeted assays are validated according to the FDA Bioanalytical Method Validation Guidance (2018) or the EMA Guidance for Bioanalytical Method Validation (2011). All other bioanalytical testing offered by Metabolon adheres to ISO 9001:2015 Quality Management Standards. ISO 9001:2015 outlines specific Quality Management System requirements with a strong focus on ensuring consistent and efficient processes, customer focus and satisfaction, and continual improvement.

The Microbiome SmartPanel is designed as a Research Use Only (RUO) product. We offer other solutions that meet GCP/GCLP, CAP, and CLIA requirements. Contact your sales representative for more information if you need to meet specific regulatory standards.

Feces samples require additional handling to process due to the additional sample preparation time for our platform.

If your project meets our standard SmartPanel requirements (sample size, volumes, etc.), most fecal studies can be completed within 8 weeks, and most serum/plasma studies can be completed in 6 weeks or less.

Microbiome SmartPanels support up to 20 statistical comparison groups.  If you have a more complex study, we recommend that you consider a customized global assay with expert guidance from our Discovery and Translational Science team.

Microbiome SmartPanel studies can be between 48 – 350 samples.  This requirement enables us to meet our rapid turnaround time commitments and achieve maximum platform efficiency.  If your study is outside of this range, we offer a host of other solutions that can meet larger study needs.  Please contact your account Representative or Study Director with any questions.

Our full sample preparation and shipping procedures document can be found here. Please note that SmartPanels may have additional restrictions that are not included in our general guidelines.

For best results, blood samples must include at least 150 μL, with fecal samples containing 100 mg of material.  Analysis on smaller samples may require additional handling charges and may not deliver the same quality of results for your study.  Please contact your Metabolon Client Success Project coordinator if you have concerns about the volume of your samples.

For best results, we recommend that you start with the Metabolon Study Success Sample Handling Kit. In order to qualify for standard turnaround times and SmartPanel pricing, samples must be submitted in Metabolon preferred tubes, including the DNA Genotech OMNImet®·GUT at-home collection and stabilization solution.

The Metabolon Study Success Sample Handling Kit will provide you with Metabolon Standard Preferred 2D barcoded sample collection tubes specifically intended for your study.

For information on other barcoded tubes that may be acceptable, please contact your Metabolon Project Coordinator.

Human and Rodent serum, plasma and feces samples can be submitted for Microbiome SmartPanel studies.

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Read about our Experimental Procedures here.

Read about our Statistical Methods and Terminology here.

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Bacterial/host origin groupings are based on our internal knowledge base and represent the most common origin of these metabolites. Because these metabolites are often produced by both bacteria and the host, our groupings can only represent a general picture and may not be definitive.