Cancer Genetics, Inc. Launches Next Generation Sequencing Panel for Diagnosis & Treatment Selection in Solid Tumors, CGI FOCUS::Oncomine™

  • CGI has launched the next-generation sequencing (NGS) panel with CLIA validation and will perform the test for both clinical care and for trials being performed by biotech and pharmaceutical companies
  • The targeted NGS panel includes 52 key genes targeted by on-market oncology drugs and published evidence (identified by the National Comprehensive Cancer Network (NCCN), College of American Pathologists (CAP), and American Society of Clinical Oncology (ASCO)

RUTHERFORD, N.J. and LOS ANGELES, March 07, 2016 (GLOBE NEWSWIRE) — Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “The Company”), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, announced today the successful CLIA validation and commercial launch of its next generation sequencing (NGS) assay FOCUS::ONCOMINE™ for solid tumors. The assay enables simultaneous testing of DNA and RNA, enabling sequencing of 35 hotspot genes, 19 genes associated with copy number variations, and 23 fusion genes, all in a single workflow. 

“Clinical demand for actionable and focused NGS panels is increasing in both the community setting and among clinical trials. By offering a focused panel that provides information for known molecular pathways and that has significant clinical evidence, we are enabling precision medicine for our customers and their patients,” said Panna Sharma, Chief Executive Officer and President of CGI.  ”For our biopharma customers, profiling with clinically actionable solid tumor panels can provide a view of pathway alterations, which links potential biomarkers to access clinical outcomes in prospective or retrospective studies at a cost similar to Sanger sequencing of just a few genes.”

With a rapid turnaround time, the FOCUS::ONCOMINE™ assay is capable of detecting thousands of clinically and pharmacologically relevant biomarkers, including single nucleotide somatic variants, insertions, and deletions. “Over the past few months we have been working closely with several clinical and biopharma customers to uniquely refine this powerful test to meet the needs of routine patient care and for state-of-the-art clinical trials. As a result, we have several customers that have ensured that we launch this NGS panel to meet market demands and generate revenue immediately.”

The technology addresses one of the main challenges of solid tumor testing – the scarcity of tissue material – requiring minimal sample input per run, enabling accurate and reliable analysis of sequences from different tumor sample types, including small biopsies and fine needle aspirates. The FOCUS::ONCOMINE™ assay is based on Thermo Fisher Scientific’s Oncomine Focus assay. It runs on the proven Ion Torrent™ NGS platform and includes the powerful Ion AmpliSeq™ library preparation technology, known to perform extremely well on formalin-fixed paraffin-embedded (FFPE) tumor tissue samples. 

FOCUS::ONCOMINE™ includes 52 key genes with multiple alterations in solid tumors targeted by on-market oncology drugs, published evidence, and identified by the National Comprehensive Cancer Network (NCCN), College of American Pathologists (CAP), and American Society of Clinical Oncology (ASCO). Since the assay enables gene fusion transcript detection, it can reduce the complexity of performing alternate fusion detection methods such as fluorescence in situ hybridization (FISH).

About Cancer Genetics

Cancer Genetics Inc. is a leader in enabling precision medicine in oncology from bench to bedside through the use of oncology biomarkers and molecular testing. CGI is developing a global footprint with locations in the US, India and China. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute. 

The Company offers a comprehensive range of laboratory services that provide critical genomic and biomarker information. Its state-of-the-art reference labs are CLIA-certified and CAP-accredited in the US and have licensure from several states including New York State.
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