A: Oncotype IQTM Genomic Intelligence Platform will be developed to include multiple tissue and liquid biopsy based tests and informational services to inform cancer treatment decisions across the patient journey.
Oncotype IQ is designed to deliver clinically relevant genomic intelligence that helps physician and patients personalize treatment decisions by revealing the individual unique biology of a patient’s tumor. Today, our current portfolio consists of OncotypeDX®, our flagship line of gene expression tests aimed at early stage breast, colon, and prostate cancer as well as Oncotype SEQ®Liquid Select, a liquid biopsy mutation panel that uses next generation sequencing to identify and assess actionable genomic alterations to help personalize treatment of patients with stage IV solid tumor cancers. To date, over 700,000 patients in more than 90 countries have had an OncotypeDX®test, resulting in billions of dollars saved in healthcare costs. Moving forward, we plan to continue to expand our portfolio to address the needs of patients at every stage of the cancer. Recently, we announced a strategic collaboration with Epic Sciences to deliver novel AR-V7 liquid biopsy test to help predict treatment response in metastatic prostate cancer patients

A: Molecular diagnostics are quickly becoming central to guiding the care of cancer patients. Advances in new treatments, including targeted and immuno therapies are incredibly exciting as they offer great promises to help cancer patients at earlier stages in their disease. But, with the multiplicity of drugs and drug combinations, combined with their targeted nature and high cost, physicians need more sophisticated and fit for purpose tests and information tools to truly personalize therapeutic regiments to the biology of a patient tumor as it evolves over the course of the disease. This will be required, not only to guide which therapy is best suited to a patient at a point in time, but also to understand whether this patient is responding to this therapy. No single technology can be used to answer such a multitude of questions. Instead, different technologies will be used to answer specific questions with the right accuracy and at an appropriate cost. Sophisticated informatics tools will also be needed to help interpret complex tests such as next generation sequencing panels and provide a longitudinal view of a patient over time.

A: Today, Genomic Health is the world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today.Moving forward, we will continue to expand our portfolio of tests and services to broaden our Oncotype IQ offerings to include tissue and liquid-based gene mutation panels, monitoring tests to track tumor status, and an easily accessed, web-based information platform to gather and help evaluate patient test results over time.

A: Next Generation Sequencing undoubtedly offers exciting new prospects in cancer diagnostics and has been an enabler for some liquid biopsy applications such as our Oncotype SEQ® Liquid Select mutation panel. At Genomic Health, we always focus first on the clinical question to be answered, and then identify the most appropriate technology to answer this question in an accurate, timely, and cost effective way. Although next generation sequencing has a bright future in cancer diagnostics, it also has limitations and it is clear to us that multiple technologies such as digital PCR, IHC, or Mass Spectrometry will also be required in order to give physicians accurate and timely answers to certain clinical questions at the right cost.

A: New technologies such as next generation sequencing are changing the paradigm in how cancer patients are being managed. With its great promise, it also brings in completely new challenges which will impact how cancer diagnostics will be regulated, adopted, and reimbursed in the future. Addressing these challenges is critical to advancing cancer care effectively. For instance, clarity, transparency,and clinically meaningful performance standards in analytical and clinical validation are some of the key challenges faced by the industry today. Other challenges in diagnostics include the appropriate reimbursement of tests so that patients can have access to these important tests and companies can continue to re-invest in research and development to continue to innovate critical technologies that are central to realizing the promise of precision medicine.