CGI Receives NY State Approval for NGS Lymphoma Panel
News Jul 02, 2016
Cancer Genetics, Inc. has announced that it has received New York State approval for it Focus::CLL™ panel, a unique next generation sequencing (NGS)-based panel for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). “This approval is a testament to CGI’s ability to provide NGS panels that meet the highest quality standards. Focus::CLL™ is a highly focused panel that is available for patient diagnosis and management as well as for CLL clinical trials,” said CGI President and CEO, Panna Sharma.
“In fact, Focus::CLL™ is currently being used in multiple global clinical trials by leading biotech and pharmaceutical companies to aid in patient monitoring and disease understanding.”The panel assesses seven genes with clinical relevance for prognosis, disease management, and treatment selection. The genes included in the panel are TP53, ATM, BIRC3, NOTCH1, SF3B1, CARD11, and MYD88. The targeted NGS panel offers actionable and immediately relevant information for clinicians.
With superior analytical sensitivity, the test is able to detect biomarker mutations and aberrations that are present at very low levels and which may be missed by other, less sensitive methodologies. Improved sensitivity can lead to enhanced diagnostic and prognostic capabilities for CLL and improved patient outcomes. In addition to being available as an individual test, Focus::CLL™ is integrated into the company’s Complete™ offering for CLL and SLL.
CLL accounts for roughly one-third of all newly diagnosed leukemia cases. Over 15,000 new cases are diagnosed in the U.S. each year, and an estimated 120,000 individuals are currently living with the disease. Recent advances in treatment for CLL have been significant, including the FDA approval of idelalisib and ibrutinib for the disease, but due to tumor heterogeneity, precisely prognosing CLL has remained a challenge.
Focus::CLL™ responds to this challenge by providing a comprehensive view of the tumor’s genomic profile, detecting mutations with relevance for prognosis and treatment selection. Focus::CLL™ is the only clinically available NGS panel that assesses these seven biomarkers with a single test.
Cryo-EM Reveals Interaction Between Major Drug TargetsNews
For the first time, scientists have visualized the interaction between two critical components of the body's vast cellular communication network, a discovery that could lead to more effective medications with fewer side effects for conditions ranging from migraine to cancer.READ MORE
New Ovarian Cancer TargetNews
Researchers have found a prescription drug, Calcitriol, approved by the Food and Drug Administration for the treatment of calcium deficiency and kidney diseases, may increase the likelihood of surviving ovarian cancer. This new study opens a potential avenue for treating ovarian cancer. Since Calcitriol is an FDA-approved drug, no additional research is needed before the drug can advance to human clinical trials for ovarian cancer.READ MORE
Sartorius Stedim Biotech and Siemens Sign Automation AgreementNews
Siemens becomes a preferred supplier for automation solutions. Product portfolio of Sartorius Stedim Biotech to feature a globally standardized automation platform in the future.READ MORE