Six blood samples in test tubes. Blood test.
Published:
12/20/2019

FREDERICK, Md. – Frederick National Laboratory for Cancer Research is a key partner in a collaboration that aims to standardize the assessment of genetic tests that use blood samples to track cancer in hospitals and laboratories across the United States.

The Foundation for the National Institutes of Health (FNIH) started the project earlier this year as part of its FNIH Biomarkers Consortium, and it features a number of collaborators from the public and private sectors. 

For its part in the initiative, the Frederick National Laboratory’s Molecular Characterization Laboratory (MoCha) entered into a three-year cooperative research and development agreement with FNIH to develop a road map for performance testing and qualification of reference materials for circulating tumor DNA (ctDNA) tests across multiple platforms. 

Circulating tumor DNA originates from dying tumor cells that spill their DNA into the peripheral blood. Liquid biopsy tests, which are thought to have many advantages over tumor biopsies including the possibility to detect cancer early through a simple blood test, are based on the detection of ctDNA. 

Currently, there are no universally recognized reference materials for ctDNA that allow researchers to determine whether a clinical sample has been processed and tested correctly and if the reported results are accurate. Though liquid biopsy research is still in its early stages, ctDNA testing is expected to become more widely adopted across clinical laboratories. As such, the need for rigorously validated reference materials is becoming pressing.

Through the FNIH collaboration, MoCha is working to address this critical need in liquid biopsy research.  

“Most labs use reference materials, which are contrived samples usually derived from cell lines, to help establish how sensitive or reproducible their tests are or as run controls,” said Chris Karlovich, Ph.D., associate director of MoCha. “However, to our knowledge no one has really demonstrated that any of these materials behave equivalently to clinical samples from cancer patients. A primary goal of this project is to do just that.”

MoCha and other members of the consortium have worked with three commercial manufacturers to formulate a set of common reference materials with clinically relevant variants. These variants are frequently found in several major cancer types, including breast, ovarian, colon, and lung. Rigorous testing of the materials at MoCha and three other core laboratories is complete, and the group next plans to pilot the materials in a real-world setting of 10 commercial and academic laboratories.   

The FNIH project includes collaborators from NIH, National Institute of Standards and Technology (NIST), FDA, academic institutions, pharmaceutical industry companies, and additional partners. 

By Max Cole, staff writer

Image: Six blood samples in test tubes. Public domain NCI image. 

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