Cancer Genetics, Inc. (OTCQB: CGIX) ("CGI"), a leader in oncology-focused personalized medicine, has launched a proprietary urogenital cancer array, UroGenRA™, intended for kidney cancer diagnosis and subtyping in its own laboratory. The company has received regulatory approvals from both CLIA and New York State and will offer the genomic microarray as part of its Kidney CompleteSM Program.
“The studies we have conducted demonstrate that it may be possible to better understand how a tumor will behave by analyzing the genetic makeup of tumor tissue obtained through biopsy.”
According to the National Cancer Institute, it is estimated that 64,000 new kidney cancer cases will be diagnosed in the United States in 2013, while approximately 13,000 patients will die from the disease. Currently, kidney cancers are classified based on morphology into several subtypes which drive treatment decision. Renal neoplasms are often initially diagnosed as small renal masses by computerized tomography or magnetic resonance imaging while patients are still asymptomatic. However, imaging techniques are of limited help in distinguishing benign and malignant forms, and determining the proper subtype.
Laparoscopic partial nephrectomy, where suspicious kidney tissue is removed, has become a common method for biopsy sampling. However, up to 30% of the removed renal masses were classified as benign after surgery indicating that such procedure may not be appropriate in certain cases. In recent years, image-guided needle biopsy has emerged as a valuable option for diagnostic testing; yet, over 15% of needle biopsies yield insufficient tissue and are considered non-diagnostic by routine histology, rendering them clinically unreliable, so that a method for accurate diagnostic is needed. CGI's UroGenRA™-Kidney provides critical genomic data that allows for an accurate discrimination among the three malignant renal cell carcinoma (RCC) subtypes - clear cell, papillary, and chromophobe RCC - and a benign form of renal cancer, oncocytoma, and for the proper therapy selection depending on the kidney cancer subtype. This genomic-based assessment has the potential to improve diagnosis and prevent unnecessary and costly surgical procedures.
Results from a research collaboration between Jonathan Coleman, M.D., at Memorial Sloan-Kettering Cancer Center, and CGI based on the use of needle biopsy specimens were presented in a poster at the 2013 Genitourinary Cancers Symposium.
"The decision to treat a renal mass is based on the tumor's biologic potential to metastasize to other sites in the body, where it can cause pain, debilitation, and death, but in many cases, these tumors may not be a threat and can be safely left alone under observation," said Dr. Coleman. "The studies we have conducted demonstrate that it may be possible to better understand how a tumor will behave by analyzing the genetic makeup of tumor tissue obtained through biopsy."
The UroGenRA™-Kidney has been developed to assist in the diagnosis of both needle biopsy and resected specimens. While in many cases, surgery is recommended after diagnosis, this test will help to devise proper therapy selection based on the tumor genomic profiling for kidney patients without the need for invasive surgery. This microarray test joins other proprietary genomic testing solutions offered by CGI that target personalized cancer treatment while reducing healthcare cost.
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