CGI’s Comprehensive Approach to Liquid Biopsy

Written by: Anna Israyelyan, MD, PhD
Manager, Biopharma Solutions

Published on:
March 2nd, 2017

Anna Israyelyan, MD, PhD
Dr. Israyelyan joined CGI in 2015. She has over 15 years of extensive cancer research and management experience in industry and academia covering wide range of medical areas, including basic, translational, and clinical research. Anna is an active member of the American Society of Hematology (ASH), the American Association for Cancer Research (AACR), and American Association for the Advancement of Science (AAAS). Dr. Israyelyan has a scientific advisory role with matrix management of scientific, technical, and operational aspects related to various biopharma projects and collaborations involving biomarkers in solid tumors and hematologic malignancies.

TECHNOLOGY AGNOSTIC LIQUID BIOPSY SOLUTIONS

As liquid biopsies have become an area of intense research, commercial activity, and a reality in cancer treatment, Cancer Genetics, Inc. (CGI; Nasdaq: CGIX) has actively taken steps to continue at the forefront in cancer diagnostics by evaluating and qualifying liquid biopsy tests for a broad range of indications.

Liquid biopsy is a minimally invasive sampling and analysis of body liquids, primarily blood, as a diagnostic and monitoring tool for diseases such as cancer. It is a simple alternative to costly and invasive surgical biopsies and procedures, allowing physicians to gather a range of information about a patient’s disease through a blood sample. Rare cell populations, including circulating tumor cells, or traces of the tumor’s DNA or RNA in the blood can give an idea about which treatments are most likely to work for each patient.

J.P. Morgan predicts the liquid biopsy market could be worth as much as $20 billion by 2020, and eventually replace traditional tissue-based biopsies. Analysts expect liquid biopsies may open the market to new, cost-effective ways to routinely assess the effectiveness of cancer therapies and detect cancers earlier, with higher sensitivity.

The traditional method of cancer diagnosis, a tissue biopsy, has several limitations. The average cost of tissue biopsy can be as high as $14,634 [1]. The cost is much higher for patients who have complications, which can result in adverse events, including hospitalization. In addition, many patients may not be candidates for a tissue biopsy due to poor underlying health. Moreover, obtaining sufficient tissue to perform traditional diagnostic procedures, such as immunohistochemistry, may not always be possible either. Even if the obtained tissue is sufficient, a tissue biopsy only provides a narrow lens into only one region of the tumor, making it difficult to see the entire tumor heterogeneity, not to mention metastatic disease. Also, due to its invasiveness, tissue biopsy, of course, cannot be used for routine patient monitoring.

Liquid biopsy holds several advantages over a traditional tissue biopsy. Liquid biopsies are significantly less costly, offer very little risk of adverse events, and greatly reduce time to treatment, providing a faster and minimally invasive personalized treatment, with improved follow-up [2, 3].

Various technologies allow the enrichment and purification of circulating tumor cells (CTCs), circulating free DNA (cfDNA), circulating small RNA, as well as extracellular mircovesicles (including exosomes) containing small RNA, mRNA and DNA.

Liquid biopsies can be performed for screening patients for trial enrollment and selecting treatments, monitoring medication effects such as drug resistance or tumor evolution, identifying recurrent or minimal residual disease (MRD) and, ideally, finding cancers in the most nascent stages to inform prognosis and guide therapies earlier.

In June 2016, cobas® EGFR Mutation Test v2 became the first FDA-approved liquid biopsy test for use in clinical decisions. Currently, the test is the only companion diagnostic that is FDA-approved for the detection of the epidermal growth factor receptor (EGFR) gene in DNA derived from plasma or tumor tissue. NSCLC patients who have EGFR exon 19 deletions or L858R mutations are candidates for the EGFR-targeted therapy Tarceva® (erlotinib), in first-line treatment, and patients who have the resistance mutation T790M are candidates for Tagrisso (osimertinib) in subsequent lines of treatment. Current clinical guidelines, including those from the National Comprehensive Cancer Network (NCCN) in the U.S., and the European Society for Medical Oncology (ESMO), recommend EGFR mutation testing in patients with advanced NSCLC, prior to administering targeted therapies.

CGI OFFERS LIQUID BIOPSY SOLUTIONS FOR RARE CELL AND cfDNA ANALYSIS ACROSS MULTIPLE PLATFORMS

CGI is actively engaged in the expanding liquid biopsy space with multiple partners evaluating various liquid biopsy platforms for clinical and research use. Companies with extensive oncology experience, like CGI, are well positioned to help sponsors navigate the rapidly advancing field of liquid biopsies for innovation and application of them as precision cancer diagnostics.

PARTNERS, PLATFORMS AND REAGENTS

ArcherDx

  • Certified Service Provider (June 2016)
  • Archer® Reveal ctDNA 28 Kit (28 genes, including EGFR, KRAS, NRAS, PIK3CA, KIT, HER2, IDH1/2, etc.)

Qiagen

  • Real-time PCR & sequencing capabilities
  • QIAseq cfDNA All-in-One Kit

Illumina

  • Included in the CSP Network

Roche

  • cobas® EGFR Mutation Test v2

ThermoFisher

  • Oncomine™ cfDNA Assays (lung, colon, breast)

ApoCell

  • ApoStream® rare cell isolation and biomarker interrogation platforms

CLINICAL TRIAL APPLICATIONS

  • Companion diagnostics (CDx)
  • Cancer panels (multi-gene) targeting actionable mutations (disease specific & pan-cancer panels)
  • Tissue surrogate translational biomarker analysis (biomarker monitoring/PD biomarkers)
  • Tissue correlation studies
  • Live cell analysis

As the field of liquid biopsy continues to explode and evolve, CGI will continue to actively engage with additional partners and technologies to develop liquid biopsy programs aiding in transforming cancer profiling and therapy selection. Our technology agnostic approach allows CGI to leverage high-performance, high-impact liquid biopsy platforms and technologies to deliver fit-for-purpose scientific solutions.

Specifically, CGI is at end-stage development of two liquid biopsy assays, both multi-gene next generation sequencing (NGS) panels, in lung and renal cancer. We will be sharing more in these pages as we get closer to finalization of assay validation and commercial launch.

Stay tuned. Liquid biopsy is a topic you will be seeing more about in CGI’s future Shared Insights. For now, for the latest news and details about CGI’s diverse liquid biopsy approaches and robust solutions, please visit ir.cancergenetics.com/press-releases.


[1] Costs of the Diagnostic Workup for Lung Cancer-A Medicare Claims Analysis

[2] International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Costs And Outcomes Comparison Of Tissue And Blood Based Biopsies For The Purpose Of Biomarker Testing For Advanced Non-Small Cell Lung Cancer. https://www.ispor.org/research_pdfs/52/pdffiles/PCN57.pdf

[3] Ilié M, Hofman P. Pros: Can tissue biopsy be replaced by liquid biopsy? Transl Lung Cancer Res. 2016 Aug;5(4): 420-3.

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