Complete::IOTM provides immune endpoint and immune monitoring of patients allowing informed therapeutic decisions and assessment of potential toxicities of IO therapies in blood cancers and solid tumors
- Complete::IOTM can determine precise details of anti-tumor immunity for each cancer patient as it allows the detection of multiple markers on an individual cell, which is limited when utilizing other technology platforms, including next-generation sequencing (NGS) and immunohistochemistry (IHC)
RUTHERFORD, N.J., April 24, 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 CLIA validation and approval of its immuno-oncology (IO) assay, Complete::IOTM. Complete::IOTM is a multi-marker, flow cytometry-based panel allowing a comprehensive characterization of the immune repertoire of cancer patients, including circulating immune cell populations and the tumor microenvironment. As IO drugs become more commonplace both as mono- and combination therapies, improved and more comprehensive technology is required to monitor and stratify patient populations during clinical trials. Complete::IOTM was designed to meet this need, and is based on the simultaneous detection of up to 10 markers on each cell, allowing identification of rare and challenging subsets of immune cells.
"With the extremely high promise of IO therapies and CGI's track record in innovative and proprietary assay development and application, we believe that Complete::IOTM will become a key tool in selecting patients, monitoring response, and predicting toxicities in IO therapies. Complete::IOTM is already being utilized in the clinical setting for both hematologic malignancies and solid tumors, and is being implemented by our biopharma partners for clinical trials in such indications as glioblastoma," said Daniel Duncan, MD, Medical Director at CGI.
Immune-modulating agents have been around for decades, but for limited use and with limited success. Newly understood immuno-oncology pathways along with more targeted IO drugs have demonstrated significant advances against a wider range of cancers. Complete::IOTM is able to help address the tremendous demand of clinical trials and routine patient care to better monitor changes, responses and potential toxicities by providing comprehensive assessment of anti-tumor immune response. CGI expects Complete::IO™ to be utilized to improve the great potential of IO drugs and become a key tool in addressing the inherent complications of assessing response and dose scheduling in immunotherapy treatments.
Currently, IO is a highly promising area of medicine and has already seen several blockbuster therapies enter the market in disease areas such as non-small cell lung cancer (NSCLC) and melanoma. Wall Street analysts are projecting over $35 billion in annual worldwide sales for immuno-oncology drugs by 2024, which could account for half of all spending on cancer drugs, according to market research firm IMS Health. Pharmaceutical analysts expect that the major biotech and pharmaceutical companies are all expected to spend nearly $1 billion a year on immuno-oncology research, early access, and development programs and clinical trials.
Complete::IOTM is built on CGI's previous experience in developing high-performance biomarker panels designed for various cancer indications, and offers optimized reagent combinations to minimize cost and unwanted technical bias. The panel analyzes dynamic changes across comprehensive immune cell populations. Besides the commonly studied subsets, Complete::IOTM is able to provide highly accurate immunophenotyping of central memory, effector, effector memory, naïve CD4+ and CD8+ T cells, T-regs, B-regs, NK, and plasmacytoid dendritic cells. Complete::IOTM allows the query of both circulating cell populations and tumor microenvironment as it can be performed on fresh tumor biopsies. The workflow has been specifically designed to maximize information yield from smaller samples. Complete::IOTM offers streamlined specimen setup and reporting for turnaround times as short as 24 hours.
"With the rise of targeted immunotherapies, CGI is committed to staying at the forefront of developing tests that are needed to advance immuno-oncology and precision therapy. Complete::IOTM can become an integral component of immuno-oncology patient monitoring for cancer centers and hospitals nationally. Additionally it can be a valuable tool for patient selection and stratification, as well as monitoring therapy effectiveness for our biopharma customers. We fully expect to continue developing the panel as it uniquely offers complex and comprehensive assessment of the patient immune response within one day of receiving the sample," said Panna Sharma, CEO and President of CGI.
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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