Metabolomics is a powerful tool for understanding biological systems and advancing disease treatments. Targeted panels—which provide absolute quantification on a subset of metabolites of interest—can answer specific research questions, uncover actionable insights, and propel new therapeutic developments. Sometimes, a targeted metabolomics panel may not exactly fit your analyte requirements: you may wish to analyze a non-validated matrix with greater confidence or prefer a narrower metabolite focus than what the available panel provides.
Customers interested in a bespoke list of analytes or who are working with unique samples or low analyte concentration can benefit from Metabolon’s Custom Method Development services for absolute quantification, allowing you to get the specific information you need without compromise—all while preserving the same advantages offered by Metabolon’s Targeted Panels.
Accurate and reproducible measurements of a number of analytes or even a single analyte can be difficult, particularly if those analytes are present in low concentrations in a sample. With Metabolon’s Custom Method Development, you can rely on our experience to develop a new and customized method to meet your needs. Custom Targeted Panels and Single Analyte Assays can be developed and validated in practically any matrix. With custom offerings, sample preparation methods can be altered and different mass spectrometers can be leveraged to increase sensitivity, maximizing the detection and sensitivity of your analytes even when working with limited sample volumes.
These customized offerings enable investigators to answer specific research questions, uncover actionable insights, and propel new therapeutic development, including novel diagnostic tests, using limited sample volumes, volatile analytes, and matrices that aren’t validated on existing commercial panels. Many of our customers are investigators and clinicians that use Custom Targeted Panels or Single Analyte Assays to inform clinical trial decision-making. When it comes time, regulatory submissions are easy because Metabolon’s methods can be designed for GCP-compliance, validated to FDA and EMA standards, and processed according to GCP/GCLP standards.
Our readily available or custom developed quantitative assays help you achieve your research and biomarker validation objectives with precise and fully validated methods. Our targeted assays and panels cover more than 1,000 metabolites and lipids across a wide range of biochemical classes, metabolic pathways, and physiological processes, and they can be customized to best fit any application.
Metabolon offers three levels of sample validation: Exploratory (research-oriented, limited validation), RUO (Routine Use Only), and GCP/GCLP (Good Clinical Practice / Good Clinical Laboratory Practice).
All methods at Metabolon are validated to adhere to Metabolon’s ISO 9001:2015 certified quality system. Validation experiments are based on the FDA, EMA, and ICH M10 Bioanalytical Guidance documents. All data are peer-reviewed, and a summary report containing the results of the validation experiment is provided.
For GCP/GCLP validation, all experiments and acceptance criteria strictly adhere to the FDA, EMA, and ICH M10 Bioanalytical Guidances. All GCP/GCLP studies are peer-reviewed and audited by the Metabolon Quality Assurance Department. A validation report containing all of the elements listed in the M10 Bioanalytical Guidance is provided.
The table below outlines all evaluated analytical performance parameters for Exploratory, RUO, and GCP/GCLP standards.
(Scroll left/right to see full table)
| Evaluated Parameters | Exploratory | RUO | GCP/GCLP |
|---|---|---|---|
| Linearity, Accuracy, and Precision of Calibration Standards | ✓ (1 run) | ✓ (3 runs) | ✓ (3 runs) |
| QC Precision Accuracy | ✓ (1 level, precision only) | ✓ (3 levels) | ✓ (3 levels) |
| Lower Limit of Quantitation | ✓ (1 run) | ✓ (3 runs) | ✓ (3 runs) |
| Selectivity | ✓ (1 run) | ✓ (3 runs) | ✓ (3 runs) |
| Carryover | ✓ (1 run) | ✓ (3 runs) | ✓ (3 runs) |
| Dilution Accuracy | ✕ | ✓ | ✓ |
| Extraction Recovery (also used to show accuracy) | ✕ | ✓ | ✓ |
| Sample Stability Testing – Benchtop Stability | ✕ | ✓ | ✓ |
| Sample Stability Testing – Freeze/Thaw Stability | ✕ | ✓ | ✓ |
| Secondary Instrument | ✕ | ✕ | ✓ |
| Parallelism | ✕ | ✕ | ✓ |
| Matrix Effect Testing | ✕ | ✕ | ✓ |
| Specificity | ✕ | ✕ | ✓ |
| Sample Stability Testing – Long-Term Stability | ✕ | ✕ | ✓ |
| Extract Stability Testing | ✕ | ✕ | ✓ |
| Run Injection Stability Testing | ✕ | ✕ | ✓ |
| Solution Stability Testing | ✕ | ✕ | ✓ |
| QA Review | ✕ | ✕ | ✓ |
While unlikely, using a validated methodology with a non-validated matrix may inflate the signal-to-noise ratio (SNR), complicating the analysis of your samples. To ensure the data we collect for your study is accurate and meets Metabolon’s quality standards for all validated Metabolon Target panels, we may ask you to first participate in an initial pilot study. This will give you an early indication of the ability of the combination of our panel and your chosen matrix to potentially detect, identify, and quantify biomarkers, allowing us to proceed with your full study with confidence.
We partner with businesses and institutions to develop targeted metabolomics services for all research areas and commercial objectives. If your study relies on a specific matrix or a unique set of analytes, inquire about our Sample Matrix Validation or Custom Method Development services. Any validation or development request will be tailored to your needs and ensure the highest possible accuracy, quality, and reproducibility for your current and future projects.
Once you see the full value of metabolomics, the only remaining question is: who does it best? While many laboratories have metabolite profiling or analytical chemistry capabilities, comprehensive metabolomics technologies are extremely rare.
Accurate, unbiased metabolite identification across the entire metabolome introduces signal-to-noise challenges that very few labs are equipped to handle. Also, translating massive quantities of data into actionable information is slow, if not impossible, for most because proper interpretation takes two things that are in short supply: experience and a comprehensive database.
Using our robust platform and visualization tools, our experts are uniquely able to tell you more about your molecule and develop assay panels to help you zero in on the results you need.
Coverage
Ability to interrogate thousands of metabolites across diverse biochemical space, revealing new insights and opportunities
Comparability
Ability to integrate the data from different studies into the same dataset, in different geographies, among different patients over time
Competency
Ability to inform on proper study design, generate high‐quality data, derive biological insights, and make actionable recommendations
Capacity
Ability to process hundreds of thousands of samples quickly and cost‐efficiently to service rapidly growing demand
Request a quote for our services, get more information on sample types and handling procedures, request a letter of support, or submit a question about how metabolomics can advance your research.
Corporate Headquarters
617 Davis Drive, Suite 100
Morrisville, NC 27560
Mailing Address
P.O. Box 110407
Research Triangle Park, NC 27709
Phone
+1 (919) 572-1711
Fax
+1 (919) 572-1721
International Headquarters
Metabolon GmbH
Zeppelinstraße 3
85399 Hallbergmoos
Germany
