News & Events
2015 was an exciting year for Insight Genetics with the formation of new partnerships, continued collaboration with existing partners, expansion of our leadership team, the launch of a CLIA-validated assay for non-small cell lung cancer (NSCLC), presentation of new research findings on triple negative breast cancer (TNBC), and new funding to continue the advancement of the company’s TNBC and NSCLC programs.
Milestones for the year include:
January 2015 – Insight Genetics and Biocept, Inc., a molecular oncology diagnostics company focused on biomarker analysis of cell-free circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), announced a collaboration to combine technologies to enable detection of the ALK gene from liquid biopsies. Biocept’s expertise in harvesting tumor DNA from blood paired with Insight Genetics’ expertise in ALK detection expands each company’s capabilities to provide molecular diagnostic solutions to advance precision medicine in non-small cell lung cancer.
March 2015 – Rob Seitz joined Insight Genetics as Chief Technology Officer and is charged with overseeing the advancement of early-stage research into clinically validated tests. Seitz is leading the company’s development and commercialization of Insight TNBCtype™, a gene expression-based algorithm for the classification of triple negative breast cancer into subtypes based on technology licensed from the Vanderbilt Ingram Cancer Center.
May 2015 – An article published in Cancer Advocacy Coalition of Canada’s Annual Report Card on Cancer by Insight Genetics’ collaborator Dr. David Saltman from the British Columbia Cancer Agency emphasizes the role of multidisciplinary teams in providing pathologists a patient biopsy for biomarker testing. The article highlights challenges associated with minimal biopsy material utilizing non-small cell lung cancer (NSCLC) as a paradigm. Additionally, the article reviews currently available diagnostic assays for the detection of EGFR and ALK, including referencing the ability of the Insight ALK Screen™ qPCR assay to detect oncogenic ALK in cases of low tumor content in biopsy samples.
May 2015 - Dr. Stephan Morris, Insight Genetics’ Scientific Founder and Chief Scientific Officer, presented at the San Francisco State University Biology Conference, “Personalized Medicine 8.0: Genetic Screening Symposium & Predictive Medicine.”
May 2015 – Insight Genetics presented new data classifying distinct molecular subtypes of serous ovarian cancer at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. The poster highlighted results from the company’s application of its proprietary Insight TNBCtype algorithm to existing serous ovarian cancer gene expression datasets and noted a similar distribution of molecular subtypes as previously found in triple negative breast cancer (TNBC). These data suggest that certain subtypes correlate with positive patient outcomes to various therapies in ovarian cancer.
June 2015 - Insight Genetics’ Chief Executive Officer Eric Dahlhauser participated in the panel, "Found in Translation: An Academia-Pharma Match-Up Sees Success," at the 2015 BIO International Convention. The panel discussed the challenges of translating basic academic research into commercially viable products. Insight Genetics and Vanderbilt University Medical Center were highlighted as a success story for their combined work on advancing diagnostics options for subtyping triple negative breast cancer (TNBC).
July 2015 - Insight Genetics’ Regulatory Scientist, Dr. Rachel Skelton, co-presented a talk with Susan Albert, Senior Director of Clinical Operations at Ce3, Inc., at the 4th Annual Clinical Operations in Oncology Trials East Coast 2015 conference. The talk, “A Cost-Effective Way to De-Risk Biomarker Clinical Trials; Early Development Considerations,” provided an overview of current FDA regulations and guidelines for in vitro diagnostics and variables to consider when utilizing diagnostics as part of a clinical trial.
Launched Proprietary Insight RET Screen for Non-Small Cell Lung Cancer
September 2015 - Insight Genetics announced the launch of its Insight RET Screen™, a CLIA-validated assay that detects oncogenic RET expression in non-small cell lung cancer (NSCLC) patients. The Insight RET Screen is a qPCR assay that detects RET expression driven by chromosomal fusions regardless of the fusion partner and is available through Insight Molecular Labs.
September 2015 - Insight Genetics presented a poster at the International Association for the Study of Lung Cancer’s (IASLC) 16th Annual Conference on Lung Cancer describing the detection of an RNA-based oncogenic biomarker from blood, which was enabled by combining Insight Genetics’ proprietary ALK qPCR technology with Biocept’s proprietary circulating tumor cell (CTC) capture technology.
November 2015 - Ronald (Ronnie) Andrews Jr. was added to the company’s Board of Directors and joined its base of private investors as part of a $3 million round of growth capital. As a board member, Andrews will serve as a strategic advisor and assist the company in commercializing its products and services.
December 2015 - The Archives of Pathology & Laboratory Medicine published an article by a group from the Department of Pathology and Genomic Medicine, Houston Methodist Hospital who performed a clinical validation of the Insight ALK Screen qPCR assay which is manufactured and distributed globally by QIAGEN as ALK RGQ RT-PCR Kit. The article concludes that the high performance of the ALK RGQ RT-PCR Kit, in combination with the ability to screen for EGFR mutations concurrently with aberrant ALK expression, has changed clinical practice at their institution especially when dealing with small amounts of clinical specimens. Utilization of the ALK qPCR assay reduced both results turnaround time and the number of patient samples sent out for costly FISH testing.
We look forward to an eventful 2016 as we continue to clinically validate and commercialize our breast and lung cancer assays, adapt these assays for compatibility with liquid biopsies and broader, multi-biomarker panels, expand collaborations with key academic institutions and commercial partners, and extend our services to the pharmaceutical industry. Precision medicine in oncology is sure to see many great breakthroughs this year and we are enthused to continue to enable the detection of genetic markers that allows for personalized therapy for cancer patients.