Rutherford, NJ - Cancer Genetics, Inc., a leader in DNA-based cancer diagnostics, announced the launch of Focus::Myeloid™, a next-generation sequencing (NGS) based panel for myeloid cancers including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN). The Focus::Myeloid™ panel will be performed in CGI’s CLIA certified lab.
Focus::Myeloid™ is designed by a consortium of recognized experts in blood cancer disorders. Utilizing NGS technology pioneered by Illumina, a global leader in next-generation sequencing technologies, the panel assesses 54 genes with clinical relevance for the diagnosis, prognosis, and management of myeloid cancers. Sanger sequencing is performed to assess abnormalities in several additional genes to provide a precise evaluation of the genetic profile of each patient’s cancer. Focus::Myeloid™ is available as an individual test and as part of 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.
“We are certain the information that Focus::Myeloid™ offers clinicians will allow them to make better-informed, genomically-guided decisions that are aligned with guidelines, and best practices. This is the type of insight that can result in more effective management of patients with myeloid cancers,” said Lan Wang, MD, Medical Director of Cancer Genetics.
There are roughly 54,000 newly diagnosed cases of myeloid cancers in the U.S. each year – 19,000 cases of AML, 15,000 cases of MDS, and 20,000 cases of MPN. Current methods for diagnosis and patient stratification are time-consuming and expensive, requiring multiple tests for different genetic mutations. Focus::Myeloid™ delivers comprehensive genomic assessment in a single test for accurate, economical, and rapid profiling of the patient’s tumor. Genetic biomarkers such as NPM1, FLT3, JAK2, KIT, and TP53 associated with these myeloid malignancies have been incorporated into clinical guidelines for diagnosis and risk assessment. In addition, CGI’s Focus::Myeloid™ panel includes within the 54-gene panel, newly discovered biomarkers that have shown significance in clinical studies and therapeutic selection.
“We currently lack sophisticated or comprehensive tools to diagnose and manage MDS in the clinical and community setting. Additionally, MDS is not easily diagnosed and is a complex disease, which can have many variables. There is tremendous need for new diagnostic tools that provide information to improve patient management. Having preliminary data from a NGS panel would be incredibly helpful in determining a definitive diagnosis, establishing treatment options, and can potentially help forecast the development of a patient’s disease,” said Dr. Shabbir Safdar, MD, of University Hematology Oncology in St. Louis, MO.
Focus::Myeloid™ is also being offered to biopharmaceutical companies as part of CGI’s clinical trials services. There are currently over 100 open clinical trials enrolling more than 9,000 patients with AML, MDS, and MPN. The Focus::Myeloid™ Panel from Cancer Genetics can not only help with clinical treatment options, but can also provide a rationale for patient enrollment in specific trials to highlight the effectiveness of the drug being tested. Genomics-assisted patient selection can improve the effectiveness and reduce the overall cost of clinical trials.
Cancer Genetics’ first disease-specific NGS panel, Focus::CLL™ for chronic lymphocytic leukemia, was launched in December 2014. The company is actively developing a pipeline of NGS panels targeting a variety of cancers, including hematological cancers and solid tumors through its internal innovation efforts. In addition, CGI expects to launch NGS panels that are currently in development through OncoSpire Genomics, its joint venture with Mayo Clinic.
“We are certain the information that Focus::Myeloid™ offers clinicians will allow them to make better-informed, genomically-guided decisions that are aligned with guidelines, and best practices. This is the type of insight that can result in more effective management of patients with myeloid cancers,” said Lan Wang, MD, Medical Director of Cancer Genetics.
There are roughly 54,000 newly diagnosed cases of myeloid cancers in the U.S. each year – 19,000 cases of AML, 15,000 cases of MDS, and 20,000 cases of MPN. Current methods for diagnosis and patient stratification are time-consuming and expensive, requiring multiple tests for different genetic mutations. Focus::Myeloid™ delivers comprehensive genomic assessment in a single test for accurate, economical, and rapid profiling of the patient’s tumor. Genetic biomarkers such as NPM1, FLT3, JAK2, KIT, and TP53 associated with these myeloid malignancies have been incorporated into clinical guidelines for diagnosis and risk assessment. In addition, CGI’s Focus::Myeloid™ panel includes within the 54-gene panel, newly discovered biomarkers that have shown significance in clinical studies and therapeutic selection.
“We currently lack sophisticated or comprehensive tools to diagnose and manage MDS in the clinical and community setting. Additionally, MDS is not easily diagnosed and is a complex disease, which can have many variables. There is tremendous need for new diagnostic tools that provide information to improve patient management. Having preliminary data from a NGS panel would be incredibly helpful in determining a definitive diagnosis, establishing treatment options, and can potentially help forecast the development of a patient’s disease,” said Dr. Shabbir Safdar, MD, of University Hematology Oncology in St. Louis, MO.
Focus::Myeloid™ is also being offered to biopharmaceutical companies as part of CGI’s clinical trials services. There are currently over 100 open clinical trials enrolling more than 9,000 patients with AML, MDS, and MPN. The Focus::Myeloid™ Panel from Cancer Genetics can not only help with clinical treatment options, but can also provide a rationale for patient enrollment in specific trials to highlight the effectiveness of the drug being tested. Genomics-assisted patient selection can improve the effectiveness and reduce the overall cost of clinical trials.
Cancer Genetics’ first disease-specific NGS panel, Focus::CLL™ for chronic lymphocytic leukemia, was launched in December 2014. The company is actively developing a pipeline of NGS panels targeting a variety of cancers, including hematological cancers and solid tumors through its internal innovation efforts. In addition, CGI expects to launch NGS panels that are currently in development through OncoSpire Genomics, its joint venture with Mayo Clinic.
