The New Paradigm for Lung Cancer Diagnosis & Monitoring

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

Published on:
May 8th, 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.

Liquid::Lung-cfDNA™

CGI Launches a Clinically Actionable, Multi-Gene, Liquid Biopsy Test for Lung Cancer Patients

The “liquid biopsy” is making cancer diagnosis and treatment monitoring more efficient, precise, and convenient for patients. In fact, it’s rapidly becoming part of the new standard of care. And, CGI is taking active steps in leveraging high-performance, high-impact liquid biopsy platforms and technologies to deliver fit-for-purpose scientific solutions to patients and biopharma companies alike…

In a previous Shared Insight post, we provided an overview of CGI’s approach to the liquid biopsy trend, detailing our solutions for rare cell and cell-free DNA (cfDNA) analysis across multiple platforms. Today, we want to share with you the details of our recent successful CLIA validation and commercial launch of CGI’s next generation sequencing (NGS) assay Liquid::Lung-cfDNA™, which detects lung tumor-derived cfDNA obtained from the plasma fraction of blood.

Lung cancer is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung cancers. It is estimated that in 2017, approximately 222,500 Americans will be diagnosed with lung cancer, and almost 156,000 will die from this disease.[1] Lung cancer is by far the leading cause of cancer death among both men and women; about 1 out of 4 cancer deaths are from lung cancer. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. More than 430,000 people alive today have been diagnosed with lung cancer at some point.

The ease with which liquid biopsies can be obtained makes them highly useful in real-time monitoring of disease progression because, in many cases, tumors evolve and may need different treatments based on the genetic changes that occur within the tumor. With tests such as Liquid::Lung-cfDNATM, we are truly moving toward making cancer diagnosis and treatment monitoring more efficient and convenient to lung cancer patients.

Liquid::Lung-cfDNA™  enables analysis of frequently mutated single nucleotide variants and short insertions / deletions in 11 genes (over 150 hotspots) with clinical relevance to non-small cell lung cancer (NSCLC), with a limit of detection (LOD) as low as 0.05% or 1 mutant copy in a background of 2,000 wild-type copies.

Liquid::Lung-cfDNA™  provides comprehensive coverage of the genes ALK, BRAF, EGFR, ERBB2, KRAS, MAP2K1, MET, NRAS, PIK3CA, ROS1, and TP53. The assay offers high sensitivity and specificity, enabling extremely low levels of detection. With an efficient workflow and fast turn-around-time (TAT), analysis requires cfDNA obtained from a single tube of blood. The carefully formulated design of the assay also provides significant cost advantages to competing tests.  Additionally, Liquid::Lung-cfDNA™  is compatible with formalin-fixed paraffin-embedded (FFPE) samples for concordance studies evaluating somatic mutations from tumors.

Drop me an email to learn more about integrating Liquid::Lung-cfDNA™ into your clinical trial biomarker strategy or to schedule a conversation to learn more about the assay performance! I’d be happy to schedule time to help evaluate and discuss how this panel and others on the CGI’s Lung Complete suite of lung cancer tests could be used to meet your clinical trial and drug development needs.

[1] American Cancer Society, Cancer Facts and Figures 2017; page18. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf

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