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) and Small Lymphocytic Lymphoma (SLL). Leukemia is the 9th most common type of cancer in the US and each year, about 15,000 people are diagnosed with CLL. CLL and SLL are mature B-cell neoplasms. Mature B-cell neoplasms exhibit clonal genomic alterations that have diagnostic and prognostic significance. CLL and SLL occur almost exclusively in adults with a median age at diagnosis of 65 to 68 years. They comprise approximately 10% of all adult hematologic malignancies, but 40% of leukemias in individuals over 65 years of age. At the present time, CLL/SLL 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 diseases 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/SLL, CGI has developed the mature B-cell neoplasm array (MatBA®) array-based comparative genomic hybridization (MatBA®-CLL/SLL) assay based on the identification of gain/loss of genomic material frequently observed in CLL/SLL and with prognostic value. The proprietary design of MatBA®-CLL/SLL is protected by the IP# 12/980,480.
MatBA®-CLL/SLL 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. For more information, please visit www.cgimatba.com.
Our most recent application of MatBA® is for the diagnosis and prognosis of Diffuse Large B-cell Lymphoma (DLBCL). DLBCL is the most common form of non-Hodgkins lymphoma (NHL) with an estimated 190,000 people in the United States suffereing from the disease and up to 24,500 new U.S. cases are diagnosed each year. DLBCL is a clinically, pathologically and genetically heterogeneous disease. Current prognostic methodologies rely primarily on clinical features. This creates a strong clinical need for accurate and molecularly-informed prognostic testing at the time of diagnosis. MatBA®-DLBCL has been both CLIA and New York State approved for clinical use.
DLBCLs exhibit clonal genomic copy number alterations (CNA) such as gain or loss of individual genomic loci as well as markers of genomic complexity. Both types of markers can be assayed by array comparative genomic hybridization (array CGH) permitting the simultaneous detection of gain/loss at multiple loci. MatBA®-DLBCL array CGH assesses the presence of CNAs associated with poor outcome following standard immunochemotherapy. For more information, please visit www.cgimatba.com.
UroGenRA™-Kidney is specifically designed to classify renal tumors into the three major malignant subtypes: clear cell renal cell carcinoma (ccRCC), papillary RCC (pRCC), chromophobe RCC (chrRCC), and one benign: oncocytoma (OC), which is critical to patient management and treatment protocols. This allows the clinician, especially in cases where there is limited biopsy material, to diagnose renal cancer and accurately classify it into the correct subtype, provide rationale for selection among surgical and non-surgical intervention or ablation, stratify patients based on prognostic information for the advancement of renal cancer into local or regional cancer which then guides decisions on surgical intervention, and guide drug trial decisions in those with metastatic disease or “unclassified” renal cancers. By histology alone over 15% of needle biopsies of renal masses are rendered non-diagnostic and about 4-6% of surgically-resected specimens are unclassifiable. RCC subtypes are characterized by well-known genomic alterations which can be utilized for classification purposes. These differential genomic alterations are assayed in the current test by array comparative genomic hybridization (array CGH) to classify both needle biopsies and surgically-resected renal specimens. This test can be useful in assisting histology for accurate classification of RCC.