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.