Approval for Liquid Biopsy Technology Hinges on Successful Protocols

liquid biopsy technologyLiquid biopsy, a non-invasive alternative to the traditional tissue biopsy, holds the promise to revolutionize cancer diagnostics and treatment. Two companies have received approval from the US Food & Drug Administration (FDA) for a liquid biopsy test as a companion diagnostic, and at least three dozen other companies are developing liquid biopsy diagnostics. Analysts project the market will exceed $10 billion by 2020.1,2 As a benchmark, the market for next-gen sequencing, arguably one of the most significant technological advances over the past 30 years, is forecasted to reach $10 billion by 2021.

We explore the clinical potential of liquid biopsy technology, analyze liquid biopsy vs. traditional tissue biopsy, and elucidate protocol implications for clinical studies using liquid biopsy technologies in our latest white paper, The Promise of Liquid Biopsy Technology: Utilizing Investigational Technologies in Oncology Trials.

Sensitive and efficient tests to find rare genetic mutations could help trial sponsors find more qualified candidates for their trials, in turn speeding recruitment and increasing the likelihood of trial success. However, in the short run, redundancies with using tissue biopsies, imaging technology and other diagnostics are necessary to prove that liquid biopsies produce comparable results to these standard techniques. Sponsors must also factor in the following considerations that can impact trial timelines and resources:

  • Employing multiple mutation panels that permit patient-population and patient-specific screening, and capture mutation targets most likely to respond to treatment
  • Developing strategies addressing sensitivity and specificity when the gold standard is less effective.
  • Assessing validity of liquid biopsies based on clinical outcomes rather than head-to-head comparison to gold standards.
  • Creating molecular oncology boards, in addition to traditional medical tumor boards, to guide treatment decisions based on more complex diagnostic data
  • Verifying any results that lead to treatment recommendations in a CLIA-certified laboratory
  • Adopting protocols with educational materials and SOPs to clarify sample handling, processing and storage for laboratories lacking deep expertise in managing time-sensitive biofluids on the new liquid biopsy test platforms

Liquid Biopsy TechnologyFor liquid biopsy developers, regulatory approval and payer acceptance will hinge on providing evidence to support the consistent and reliable specificity of mutation detection, as well as tying that evidence to predicting patient treatment. You can learn more about the state of the liquid biopsy market here, or if you have immediate questions about seeking FDA approval for liquid biopsy tests, ask us.


  1. Sullivan, Laurie. “Liquid Biopsies for Cancer Screening: An Emerging Sector of the POC Blood Testing Market” BCC Research. June 15, 2015.
  2. Winslow, R. “Genomic Health Plans Line of Liquid-Biopsy Tests for Cancer.” Wall Street Journal. Jan. 11, 2015.
  3. Terry, M. “Illumina (ILMN) Raises $100 Million with Amazon (AMZN)’s Bezos, Bill Gates and Others to Launch Pan-Cancer Test. Company Grail.” Jan. 11, 2016.
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