NGS for cancer Dx
REDWOOD CITY, Calif.óGenomic Health Inc. and OncoMed Pharmaceuticals Inc. have formed a strategic alliance that will use next-generation sequencing (NGS) to identify biomarkers that can be applied to the clinical development of OncoMed's novel antibody cancer therapeutics.
"Working with like-minded, innovative cancer companies, we can utilize our proven next-generation sequencing-based diagnostic research and development infrastructure to help optimize patient selection to accelerate clinical development of targeted cancer treatments," says Dr. Steven Shak, Genomic Health's chief medical officer. "This collaboration supports our long-term vision and belief that molecular diagnostics are inherent for bringing quality, personalized care to all cancer patients from diagnosis through survivorship."
Under the terms of the agreement, OncoMed will provide Genomic Health with breast, prostate, colon and lung tumor samples. A subset of these tumors will include OncoMed's extensive bank of proprietary xenograft models derived from freshly resected human cancers. Genomic Health will apply its NGS capabilities, including proprietary sample preparation, high-throughput sequencing and bioinformatics, to discover biomarkers that can help identify subsets of patients that will more likely respond to cancer therapeutics targeting the Notch, Wnt and other pathways critical to cancer stem cells.
Shak points out that the company has made major strides in the utilization of NGS technology to assay the entire genome simultaneously to discover regions where expression is associated with clinical outcomes and treatment response. In 2011, the company announced its decision to accelerate the program into clinical development studies examining both RNA-Seq gene expression and mutation analysis. This decision followed the successful completion of the clinical outcomes study for biomarker discovery using NGS for whole transcriptome profiling of fixed tumor specimens.
"Our priority is not only to develop therapeutic antibodies but to target their clinical use in the subsets of patients most likely to benefit through focused clinical plans, which include patient selection strategies at early stages of testing," says Paul J. Hastings, president and CEO of OncoMed. "We believe the collaboration with Genomic Health will accelerate our already existing efforts of developing predictive biomarkers alongside the development of our anti-cancer stem cell therapeutics."
Genomic Health's lead product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and to predict the likelihood of recurrence in ductal carcinoma in situ. A genomic test, such as Oncotype DX, looks at groups of genes and how active they are. This activity can influence how a cancer is likely to grow and respond to treatment.
Unlike a breast cancer genetic test, the Oncotype DX breast cancer test does not provide information about a person's inherited genetic make-up. Instead, it looks at genes in a patient's breast tumor to understand how these genes interact and influence the tumor's behavior. Based on the multi-gene analyses of the tumor sample, Oncotype DX assigns the breast cancer a Recurrence Score. This score is a number between 0 and 100 that corresponds to a specific likelihood of experiencing breast cancer recurrence within 10 years of initial diagnosis. The lower your score, the less likely the cancer is to recur, in which case chemotherapy treatment is likely to be of little if any benefit. The higher the score, the more likely the cancer is to recur, in which case chemotherapy may be beneficial in reducing this risk of recurrence.
In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. As of March 31, more than 10,000 physicians in more than 65 countries had ordered upwards of 275,000 Oncotype DX tests.
Privately held OncoMed Pharmaceuticals is a clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells believed to be capable of driving tumor growth, recurrence and metastasis. The company has established a library of antibodies to cancer stem cell proteins for the treatment of solid tumors such as pancreatic, breast, colorectal and lung cancers.