- CGI has launched the multi-gene, next-generation sequencing (NGS) panel with CLIA validation, and will perform the test for both clinical care and for trials being performed by biotech and pharmaceutical companies
- The targeted NGS panel provides comprehensive coverage of 11 critical genes and over 150 key hotspots related to lung cancer
- The paradigm-breaking test, Liquid::Lung-cfDNA™, achieves a limit of detection (LOD) down to 0.05% from both blood and tissue samples
RUTHERFORD, N.J. & LOS ANGELES, May 08, 2017 (GLOBE NEWSWIRE) -- 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.
ABOUT CANCER GENETICS
Cancer Genetics Inc. is a leader in enabling precision medicine in oncology from bench to bedside through the use of oncology biomarkers and molecular testing. CGI is developing a global footprint with locations in the US, India and China. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute.
The Company offers a comprehensive range of laboratory services that provide critical genomic and biomarker information. Its state-of-the-art reference labs are CLIA-certified and CAP-accredited in the US and have licensure from several states including New York State.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to Cancer Genetics Inc.’s expectations regarding the completion, timing, pricing and size of the offering described in this press release constitute forward-looking statements.
Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, risks of cancellation of customer contracts or discontinuance of trials, risks that anticipated benefits from acquisitions will not be realized, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Cancer Genetics, Inc. Form 10-K for the year ended December 31, 2015 and the Form 10-Q for the Quarter ended March 31, 2016 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements.
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