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Cancer Genetics Kidney Cancer Test Approved by CLIA, New York

NEW YORK (GenomeWeb News) – Cancer Genetics said today it has received CLIA and New York approval to offer its microarray-based kidney cancer test.

As a result, the Rutherford, NJ-based firm has launched the test, called UroGenRA-Kidney, as part of its Kidney Complete Program. The test is intended for kidney cancer diagnosis and subtyping in its own laboratory, said Cancer Genetics, which went public in early April.

The test provides genomic data for differentiating the three malignant renal cell carcinoma subtypes — clear cell, papillary, and chromophobe RCC — from oncocytoma, a benign form of renal cancer. The test also is to help clinicians determine appropriate treatment, depending on the cancer subtype.

According to Cancer Genetics, UroGenRA-Kidney may "improve diagnosis and prevent unnecessary and costly surgical procedures."

The test was developed to aid in diagnosing needle biopsy and resected specimens. In many cases, surgery is recommended after diagnosis, but for those patients who don't require surgery, the test will help in deciding on an appropriate therapy based on the tumor genomic profiling, the company added.