Cancer Genetics' (CGIX) Focus::Myeloid NGS-Based Panel Receives Approval in New York State

August 17, 2016 7:32 AM EDT

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Cancer Genetics, Inc. (Nasdaq : CGIX) announced 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. (Accessed on 8-15-2016)

[2] Leukemia & Lymphoma Society; Facts and Statistics. (Accessed on 8-15-2016)

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