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Cancer Genetics, Inc. Launches The Most Comprehensive & Clinically Actionable Next Generation Sequencing Panel in Precision Medicine, FOCUS::LymphomaTM

Published on: Tuesday, May 17th, 2016 View all Media

  • The panel provides Critical Genomic Information To Improve Patient Management & Guide Therapy Decisions
  • FOCUS::Lymphoma™ panel is being used to power several clinical trials with biotech and pharmaceutical companies, and is now available for use in a clinical setting
  • FOCUS::Lymphoma™ can be personalized to report on clinically actionable gene mutations present in the most common types of B-cell lymphomas which represent nearly 300,000 patients living with the disease in the USA

Rutherford, N.J. and Los Angeles, CA, May 17, 2016 – 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 CLIA validation and commercial launch of its next generation sequencing (NGS) panel, FOCUS::Lymphoma™ for use with the most common mature B-cell lymphomas. The panel enables the targeted sequencing of 220 genes and has the ability to customize reporting that provides clinically actionable information to determine treatment options for patients with various forms of B-Cell Lymphomas.

“In an era of expanding molecular diagnostics the CGI FOCUS::Lymphoma™ panel provides a powerful, clinically validated tool for molecular characterization of lymphomas, B-cell neoplasms in particular.  I am impressed by the rigorous validation and high quality of the panel.  While remaining disease-focused, the panel is quite comprehensive in the breadth of mutations covered,” said Imran Siddiqi, M.D., Ph.D., Associate Professor of Clinical Pathology at the Keck School of Medicine at the University of Southern California. “We utilized this panel to evaluate a series of patients with an unusual diffuse follicular lymphoma variant.  This testing identified STAT6 mutations in the vast majority of these cases, a novel finding for this variant.  Notably, STAT6 is not represented on most of the other commercially available, CLIA-certified lymphoma panels.  The FOCUS::Lymphoma™ panel is a significant addition to the clinical/pathologic workup of patients with non-Hodgkin lymphomas.”

Some of the clinically significant aspects of the panel are its ability to detect mutations in genes such as BTK and PLCG2, which have recently been attributed to therapy resistance. The panel also offers information on genes such as KMT2D, which is frequently mutated in B-cell lymphomas, but is not currently available through other commercial platforms.  Altogether, the panel encompasses genes that are associated with outcomes, are actionable targets, are related to biologically significant pathways, and/or are frequently mutated in mature B-cell lymphomas. Many oncologists find CGI FOCUS::Lymphoma™ panel very impactful for their patients:

”We recently treated a relapsed patient with a NRAS Q61R mutation in his tumor cells, identified using the CGI FOCUS::Lymphoma™ panel and were gratified to see a response with MAP kinase targeting drugs even when his disease had progressed after multiple lines of chemotherapy,”  said Dr.Samir Parekh, M.D.,  Associate Professor at Mount Sinai School of Medicine in New York.

Since its introduction into the clinical trial setting in early 2016, FOCUS::Lymphoma™ has been in demand by pharmaceutical and biotech companies and has been instrumental in the advancement of lymphoma therapies as part of several clinical trials. Now FOCUS::Lymphoma™  is also available for routine clinical management and therapy selection for lymphoma patients, giving hope to patients who at times have failed first line treatments.

By focusing on Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), the panel has allowed for a more comprehensive coverage of genes contributing to the growth and development of improved precision testing in the marketplace. The test’s knowledge-based selection of common mutations found in B-cell lymphomas can aid in the development of personalized treatment with appropriately selected, targeted combination therapies in patients that fail first line treatment. Additionally, the information provided by the panel can further advance the development of treatments to maximize future clinical options.

Focus Lymphoma

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, Australia 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.

For more information, please visit or follow CGI at:
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Forward-Looking Statements:
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, 2017 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.