Measurement of cancer biomarkers in blood and other fluids is key to fully realizing the benefits of precision medicine. The most widely used blood-based biomarker today is circulating tumor DNA (ctDNA), and a growing number of technologies allow cancer researchers to enrich, isolate, expand and interpret ctDNA. Although the diversity of these technologies spurs innovation and provides a range of cancer diagnostic options for patients, clinicians and researchers, it also challenges current efforts to standardize the use of ctDNA assays and to interpret their results. This lack of standardization makes it difficult to trust and to fully understand the results of each individual assay. Thus, cancer researchers urgently need universally recognized quality control materials to verify that all steps in a testing process are executed correctly, enable comparison among assays across different laboratories and platforms and provide accurate results.
The ctDNA Quality Control Materials project, in partnership with commercial reference material manufacturers, seeks to develop a set of nationally recognized standards to enable the production of suitable quality control materials that can be cleared by FDA for widespread use in ctDNA testing. Once disseminated, these reference materials help cancer researchers to meaningfully interpret ctDNA biomarker assay results, thereby enabling more effective clinical research, patient treatment, regulatory evaluation and care expense reimbursement.
This project’s development of widely applicable ctDNA quality control materials will provide a pathway to accelerate regulatory approval for use of novel fluid biopsy technologies. In addition, the processes developed to authenticate production of these quality control materials could serve as a prototype for the development and validation of reference materials for other assays evaluating genomic material.
This project is a member of the International Liquid Biopsy Standardization Alliance (ILSA) Collaborative Community. For more information, please visit fnih.org/ILSA.
- American Society of Clinical Oncology*
- Association for Molecular Pathology*
- National Cancer Institute
- National Institute of Standards and Technology*
- U.S. Food and Drug Administration
- AstraZeneca Pharmaceuticals, LP*
- Genentech, a member of the Roche group*
- Horizon Discovery Ltd*
- Janssen Research & Development, LLC*
- Merck Sharp & Dohme Corp.*
- Pfizer Inc*
- SeraCare Life Sciences, Inc.*
- Thermo Fisher Scientific*
- College of American Pathologists*
- Dana-Farber Cancer Institute
- Frederick National Laboratory for Cancer Research*
- Harvard University*
*Provides financial or in-kind support for this program.
- Solicit support for, and input on, the design of ctDNA reference materials from multisector stakeholders including industry, National Cancer Institute (NCI), U.S. Food and Drug Administration (FDA), National Institutes of Standards and Technology (NIST), American Society of Clinical Oncology (ASCO), College of American Pathologists and various academic institutions.
- Define key parameters/requirements for ctDNA quality control materials and their intended use.
- Work with commercial control companies to develop ctDNA quality control materials.
- Conduct analytical validation studies using the quality control materials as they are developed and assembled into their final versions.
- Conduct a clinical pilot study across internal and external academic and commercial laboratories to extend the project’s commutability analysis and to establish the clinical value of resulting ctDNA quality control materials.
- Orchestrate, manage and submit publications on developing ctDNA quality control materials.
- Validation of ctDNA Quality Control Materials Through a Precompetitive Collaboration of the Foundation for the National Institutes of Health, in JCO Precision Oncology (JCO PO)
- GenomeWeb (January 21, 2020): The FNIH Team Selects Cancer Biomarkers in Phase I of Liquid Biopsy Reference Standards Project Read more
- FNIH Announcement (September 24, 2019): The FNIH Biomarkers Consortium Launches Project that will Standardize the Measurement of Genetic Blood Tests to Track Cancer Read more