CGH Microarrays

Microarray based technology has provided a platform on which a large number of genetic and epigenetic alterations can be assessed in a single experiment. One application of this technology, known as array CGH (or microarray) is utilized to evaluate DNA copy number changes (gain/loss) observed frequently in tumor genomes. CGI has designed targeted arrays wherein different regions of the human genome are represented, for diagnostic and prognostic purposes in a variety of human cancers.

CGI has released in 2010 a new microarray targeting genomic regions whom gain/loss have been shown to be involved in Chronic Lymphocytic Leukemia (CLL). Leukemia is the 9^th most common type of cancer in the US and each year, about 15,000 people are diagnosed with CLL. CLL is one type of mature B-cell neoplasm. It occurs almost exclusively in adults with a median age at diagnosis of 65 to 68 years. It comprises approximately 10% of all adult hematologic malignancies, but 40% of leukemias in individuals over 65 years of age. At the present time, CLL is often detected in asymptomatic patients with an elevated lymphocyte count in a routine full blood count. Definitive diagnosis is based on a lymphocytosis and characteristic lymphocyte morphology and immunophenotype. Two major staging systems for the disease exist: Rai and Binet, which are useful for stratifying patients for clinical research studies, and have guided care and treatment approaches. The staging systems however, do not permit the identification of a significant proportion of patients with early stage disease that unexpectedly become active and refractory to treatment or with stable versus aggressive late stage disease. Thus, for a disease entity that presents predominantly in an aging population, accurate prognostication for treatment options is highly desirable.

In order to further assist in the diagnosis and prognosis of CLL, CGI has developed the mature B-cell neoplasm array (MatBA®) array-based comparative genomic hybridization (MatBA®-CLL) assay based on the identification of gain/loss of genomic material frequently observed in CLL and with prognostic value. The proprietary design of MatBA®-CLL is protected by the IP# 12/980,480.

MatBA®-CLL has been CLIA accredited in November 2010 and New-York State licensed in March 2011. MatBA® is the first oncology-focused microarray to be licensed in New-York State.