RUTHERFORD, N.J. & LOS ANGELES, C.A., 8th May 17; The targeted NGS panel provides comprehensive coverage of 11 critical genes and over 150 key hotspots related to lung cancer.
Cancer Genetics, Inc. (Nasdaq: CGIX; “CGI” or “The Company”), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, announced today the successful validation and commercial launch of its next generation sequencing (NGS) assay Liquid::Lung-cfDNA™ to detect lung tumor-derived cell-free DNA (cfDNA) obtained from the plasma fraction of blood. The assay enables analysis of frequently mutated single nucleotide variants and short indels in 11 genes with significant clinical relevance to non-small cell lung cancer (NSCLC). The breakthrough test has a limit of detection (LOD) as low as 0.05% or 1 mutant copy of DNA in a background of 2,000 wild-type copies of DNA.
Dr. Barbara Gitlitz, Associate Professor of Clinical Medicine at Keck School of Medicine of USC, and a global thought leader spearheading multidisciplinary lung cancer programs, commented, “As liquid biopsies become a reality in cancer care, integrating them into clinical practice for routine management of cancer patients is pivotal. Having a high-quality provider of novel liquid biopsy assays geared toward lung cancer will help the members of our multidisciplinary treatment teams to come up with the best, individualized treatment plan for each lung cancer patient.” Dr. Gitlitz continued, “By offering a comprehensive panel that provides information for known molecular pathways and has significant clinical evidence, CGI will enable high-quality precision medicine for lung cancer patients.”
“Over the past few months we have been working closely with several clinical and biopharma customers to uniquely refine this powerful test to meet the needs of routine patient care, and for state-of-the-art clinical trials. Clinical demand for actionable and focused NGS panels for liquid biopsies is increasing in both the community setting and among clinical trials, as liquid biopsies enable new, less-invasive methods for detection and monitoring. By offering a focused liquid biopsy panel that provides information for known molecular pathways and has significant clinical evidence, we are enabling a new era in precision medicine for our customers and their patients, leading to improvements in standard of care in the future”, said Panna Sharma, Chief Executive Officer and President of CGI.
Liquid::Lung-cfDNA™ offers several advantages compared to conventional solid tumor samples. Liquid biopsy samples are less invasive to obtain, enabling tumor content to be sampled multiple times and with significantly lower cost compared to traditional tissue sampling. The Liquid::Lung-cfDNA™ assay is based on ThermoFisher Scientific’s Oncomine™ Lung cfDNA assay. It runs on the proven Ion S5™ XL sequencing system and includes the powerful Ion AmpliSeq™ library preparation technology. In addition, the assay is compatible with FFPE samples for possible concordance studies.
