Array Comparative Genomic HybridizationMicroarray-based technology has provided a platform on which a large number of genomic aberrations can be assessed in a single experiment. CGI is focused on one application of the microarray technology, known as array comparative genomic hybridization or array-CGH, to detect DNA copy number changes (gain/loss) frequently observed in cancers. Targeted arrays in various stages of design and development include those for diagnostic and prognostic purposes in lymphomas, genitourinary cancers, gynecological cancers and leukemias.
UroGenRA® is a CGI custom-designed oligonucleotide array for implementation within a clinical laboratory as an array-CGH-based diagnostic/prognostic tool for kidney, prostate, and bladder cancers. It was designed to detect gains and losses that frequently occur in these three cancer types and that have the potential to differentially diagnose and/or stratify patients to assist and guide clinical management. For kidney cancer, it is specifically designed to classify tumors into the four main types (three malignant, one benign) critical at several levels in patient management: diagnosis of image-guided needle biopsies of small incidentally discovered kidney masses providing rationale for surgical/non-surgical management, diagnosis in patients with larger neoplasms to stratify for risks of local or regionally advanced disease that can be factored in to treatment selection recommendations (i.e., extent of surgical intervention, less invasive options or ablation), in those with metastatic disease, where drug trials are currently based on post-surgical tumor diagnosis, and potentially in the diagnosis of the so-called morphologically “unclassified” renal cancers. Additionally within the predominant subtype, clear cell renal cell carcinoma, prognostication is feasible based on the presence/absence of gain and loss of certain genomic regions. For prostate cancer, UroGenRA®, has the potential to assess prostate core/needle biopsy genomic variability, to identify biomarker for inclusion in nomograms for assessment of risk of biochemical recurrence, to assess radiocurability and treatment options for intermediate risk patients, and to explore the genomic aberrations of circulating tumor cells. For bladder cancer, UroGenRA® has application in identifying tumors most likely to recur, and of muscle-invasive lesions those most likely to benefit from treatment.