Fort Myers, FL - June 2, 2017 – NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today an expansion of its ImmunoOncology profiling test menu to reflect recent advances in immunotherapy. The Company has expanded its NeoTYPE® cancer profiles to include Tumor Mutation Burden (TMB) and microsatellite instability (MSI) testing.
TMB is a new genomic biomarker that is designed to predict response to checkpoint inhibitor immunotherapies targeting the PD-1 and PD-L1 proteins. Studies in lung, melanoma and bladder cancers showed that objective response to checkpoint immunotherapy was predicted by the presence of high TMB. TMB tests will be available on a standalone basis, and in combination with the various cancer-specific NeoTYPE® Profiles offered at NeoGenomics.
MSI testing is being added to our profiling in response to the FDA’s announcement1 on May 23rd that Merck’s Keytruda drug was approved for the treatment of patients with metastatic solid tumors that have been identified as being MSI-high or mismatch repair deficient (MMR). NeoGenomics offers MSI and MMR testing as part of its comprehensive testing services.
Dr. Maher Albitar, the Company’s Senior Vice President, Chief Medical Officer and Director of Research and Development, commented, “Despite the significant success of checkpoint inhibitor immunotherapies, not all patients respond to therapy and there is a need to identify the subset of patients that are more likely to respond. NeoGenomics provides a broad range of cancer immuno-profiling tests, including TMB, MMR, MSI, and PD-L1 expression testing, to more precisely determine which patients are good candidates for immunotherapy. This immuno-profiling is combined with genomic profiling for comprehensive multimodality cancer profiling.”
Douglas VanOort, NeoGenomics’ Chairman and Chief Executive Officer, stated "This timely expansion of our state-of-the-art testing services will help physicians better identify which 2 patients will respond to new advanced immunotherapies. The FDA’s announcement last week that it has now approved a drug based on a tumor’s biomarkers without regard to the tumor’s original location is a major development in the fight against cancer, and it aligns well with our extensive menu of tests that examine cancer biomarkers. Our combination of immuno-oncology testing and genomic profiling using a variety of advanced test methodologies is a demonstration of our commitment to be a leader in precision medicine."
1. U.S. Food and Drug Administration (FDA) Press Release, 5/23/2017, FDA Approves First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature.
About NeoGenomics, Inc.
NeoGenomics, Inc. specializes in cancer genetics testing and information services. The Company provides one of the most comprehensive oncology-focused testing menus in the world for Physicians to help them diagnose and treat cancer. The Company’s Pharma Services division serves pharmaceutical clients in clinical trials and drug development.
Headquartered in Fort Myers, FL, NeoGenomics operates CLIA certified laboratories in Aliso Viejo, Fresno, Irvine, and West Sacramento, California; Tampa and Fort Myers, Florida; Houston, Texas and Nashville, Tennessee. NeoGenomics serves the needs of pathologists, oncologists, academic centers, hospital systems, integrated service delivery networks, and managed care organizations throughout the United States. For additional information about NeoGenomics, visit www.neogenomics.com.
Forward Looking Statements
Except for historical information, all of the statements, expectations and assumptions contained in the foregoing are forward-looking statements. These forward-looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated in the forward-looking statements. Actual results could differ materially from such statements expressed or implied herein. Factors that might cause such a difference include, among others, the company’s ability to continue gaining new customers, offer new types of tests, and otherwise implement its business plan. As a result, this press release should be read in conjunction with the company's periodic filings with the SEC.
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Steven C. Jones
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