Cancer Genetics (CGIX) Announces Launch of Focus::Renal

November 2, 2016 7:21 AM EDT

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Cancer Genetics, Inc. (Nasdaq: CGIX) announced the successful CLIA validation and approval of its next generation sequencing (NGS) assay that enables an era of precision medicine for renal cancers, Focus::Renal™. Focus::Renal™, a highly-sensitive NGS panel, detects mutations of 76 renal cancer-related genes, as well as genome-wide copy number changes, and critical single nucleotide polymorphisms (SNPs), all in a single test, that enable precision diagnosis, prognosis, and therapy selection for renal cancer patients.

Renal cancer accounts for 5% of adult cancers in the United States with an estimated 62,700 new cases and 14,240 deaths in 2016 [1]. The most common renal neoplasm is renal cell carcinoma (RCC). Clear cell RCC (ccRCC) accounts for ~75% of RCC, with malignant subtypes papillary RCC (pRCC) and chromophobe RCC (chrRCC), and the benign neoplasm oncocytoma (OC) mostly comprising the remainder. ccRCC has a poorer prognosis than papillary and chromophobe RCC malignant subtypes. About one fourth of the patients with ccRCC present with metastatic disease at diagnosis while 20-40% of those with locally confined tumor tend to develop metastasis.

There are seven FDA-approved targeted therapies (including VEGF-TKIs, anti-VEGF monoclonal antibody, and mTOR inhibitors) and one immunotherapy (anti-PD1 checkpoint inhibitor) available to date to treat metastatic RCC – which makes therapy selection more challenging and yet more critical. Currently, there is a growing body of evidence showing that mutations, copy number changes, and certain polymorphisms correlate with patient outcome and therapy response, and can be critical in enabling precision medicine. In addition, there are over 200 open clinical trials enrolling patients with renal cancers. At present, comprehensive genomic profiling of renal cancer patients has become an important need due to its potential impact on precision diagnostics and the development of tailor-made therapies, resulting in improved cancer care.

Focus::Renal™ is a unique NGS panel, developed by CGI in collaboration with leading cancer centers and academic institutions, including MSKCC, Cleveland Clinic, Huntsman Cancer Center at University of Utah, and University Hospital of Paris. Focus::Renal™ is a comprehensive and accurate genomic profiling tool covering the majority of renal cancer markers and pathways. Focus::Renal™ is designed based on the most current scientific literature, TCGA genomic data, and in-house findings as a result of collaborations with leading research institutions, and has undergone multiple independent validations using samples from over 500 patients. The test can be performed on a wide variety of patient specimen types, such as needle biopsies, fine-needle aspirates, and resected specimens using both formalin-fixed paraffin-embedded (FFPE) and fresh/fresh-frozen specimens, including the ones with minimal starting material, giving clinicians a choice on how to incorporate the test into their diagnostic workflow. The Focus::Renal™ NGS panel can be utilized to distinguish among the dominant 3 malignant and 1 benign renal cancer subtypes, which is today largely driven by morphological and immunohistochemical review.

"Focus::Renal™ has the ability to significantly facilitate the personalized care for renal cancer patients and also generate future insights; as the deeper understanding of molecular abnormalities will enhance the development of more effective therapies for RCC. Implementing precision medicine for kidney cancer patients requires powerful and targeted tools like Focus::Renal™. Our immediate plans include collaborations with biopharma and academic partners to implement Focus::Renal™ for liquid biopsies so that this critical test can also inform cancer care directly from blood," said Panna Sharma, Chief Executive Officer and President of CGI.

[1] Siegel RL, Miller KD, Jemal A: Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30.



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