February 2016 Edition Vol.11, Issue 2

Hope and Hype: Questions Surround Liquid Biopsies

Meeting the demands of regulators and payers

Developing data to support the use of liquid biopsies is key to moving them to market.

“Treatment decision making is becoming more binary,” Dr. Miller said, meaning choosing a treatment depends on if a marker is present, and if it is, a veritable homerun or a strikeout could result if the marker is absent. “The mandate should be higher on assays being used to make those decisions. We embrace that philosophically, and we’re well-positioned to address regulatory oversight that might come forward.”

Similarly, Dr. Spetzler emphasized the importance of high quality testing. He said, “We believe more regulations are appropriate to ensure quality and utility standards. We expect studies that test impact on patient survival to be required.”

“Payers demand demonstration of clinical utility,” said Dr. Spetzler. He stated that many tests use code stacking, but he expects that to change, with studies testing impact on patient survival becoming required.

“I believe more studies and clinical utility data are needed to further validate the most relevant approaches for a true liquid biopsy,” said Dr. Spetzler. “That said, this is such an exciting time for molecular science and the role it plays in helping cancer patients fight their disease."

Liquid biopsies offer a lot of promise, and research to develop them will move personalized treatment forward. Questions still remain. What is best to test? How comprehensive should this testing be? Can liquid biopsies get us to a “panomic” approach that encompasses the genome, the proteome and other “-omes”? If so, how can this technique be priced to be accessible to patients?


1. Sundaresan TK et al. Detection of T790M, the acquired resistance EGFR mutation, by tumor biopsy versus noninvasive blood-based analysis. Clinical Cancer Research 2015; doi: 10.1158/1078-0432.CCR-15-1031.

2. Husain H et al. Kinetic monitoring of EGFR exon 19 del, L858R, and T790M in urinary circulating tumor DNA predicts radiographic progression and response in patients with metastatic lung adenocarcinoma. American Society for Clinical Oncology 2015 Annual Meeting. Abstract 8081.

3. Karachaliou N et al. Association of EGFR L858R mutation in circulating free DNA with survival in EURTAC trial. JAMA Oncology 2015; doi:10.1001/jamaoncol.2014.257.

4. Domenyuk V et al. Adaptive dynamic artificial poly-ligand targeting (ADAPT): aptamer-based profiling of liquid biopsies to improve the accuracy of breast cancer diagnoses in women with dense breast tissue. San Antonio Breast Cancer Symposium, December 8-12, 2015. Poster P2-01-08.

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