- Focus::Myeloid™ can help clinicians and cancer centers improve the management and treatment of more than 275,000 patients in the U.S. currently living with myeloid malignancies
- Focus::Myeloid™ is a targeted NGS panel for myeloid malignancies with 54 genes designed to provide actionable information for clinical management of patients and for use in clinical trials
RUTHERFORD, N.J., Aug. 17, 2016 (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 that it received New York State approval for its Focus::Myeloid™ NGS-based panel for myeloid malignancies including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN).
“This New York State approval is another tribute to CGI’s ability to provide NGS panels that meet the highest quality standards and improve patient care. Focus::Myeloid™ is a highly sophisticated panel designed by a consortium of recognized experts in hematological malignancies. CGI will tailor the report output to provide test results for specific myeloid cancer indications, including AML, MDS, and MPN,” said CGI President and CEO, Panna Sharma.
Focus::Myeloid™ is a unique NGS panel with 54 genes providing actionable information for improved diagnosis, prognosis, therapy selection, and risk stratification of myeloid cancer patients. Based on the result of the test, each patient can receive the most suitable treatment tailored to their unique myeloid cancer. In addition to being available as an individual test, Focus::Myeloid™ is integrated into the company’s Complete™ programs for AML, MDS, and MPN, which offer a comprehensive assessment of the molecular genetics of the cancer along with pathology and morphological information.
Focus::Myeloid™ surpasses other sequencing methodologies with superior analytical sensitivity and offers robust specificity (>99%). It is designed to deliver faster results on the four well-established biomarkers (NPM1, FLT3, CEBPA, KIT), which expands therapy options for patients. Focus::Myeloid™ also allows the identification of patients classified as very low to intermediate risk by the International Prognostic Scoring System (IPSS) that could benefit from more aggressive therapies.
There are roughly 55,000 newly diagnosed cases of myeloid cancers in the U.S. each year – 20,000 cases of AML, over 15,000 cases of MDS, and 20,000 cases of MPN [1, 2]. There are over 100 open clinical trials enrolling more than 9,000 patients with AML, MDS, and MPN. Focus::Myeloid™ delivers comprehensive genomic assessment in a single test for accurate, economical, and rapid profiling of the patient’s cancer. By personalizing diagnosis and improving risk stratification, NGS-based Focus::Myeloid™ not only helps with clinical treatment options, but can also provide a rationale for patient enrollment in specific clinical trials to highlight the effectiveness of the drug being tested.
You can find more information about Focus::Myeloid™ at the CGI website.
[1] SEER Stat Fact Sheets. Surveillance, Epidemiology, and End Results Program, National Cancer Institute. http://seer.cancer.gov/statfacts. (Accessed on 8-15-2016)
[2] Leukemia & Lymphoma Society; Facts and Statistics. http://www.lls.org. (Accessed on 8-15-2016)
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.
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 future financial and/or operating results and potential for our tests and services, and future revenues or growth 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 June 30, 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.