With Today’s Announcement Next-Generation Sequencing And Precision Medicine Has Evolved From Research To The Clinical Cancer Setting:
- CLIA-Certification of a Comprehensive Whole Genome tumor normal DNA, RNA and Quantitative Proteomic Sequencing Test (GPS Cancerä)
- Insurance coverage for GPS in patients with Cancer
- Adoption of a payer-provider web-based collaboration platform, called NaviNet Open, enabling doctors and payers to share information in real time with access to over 90% of covered lives in the United States
- CLIA/CAP certification of a Platinum-Rated Human Tissue Repository
Presentations by NantHealth (8:00am) and Independence Health Group (2:30pm) on Monday, January 11, 2016 at J.P. Morgan Healthcare Conference in San Francisco, California
San Francisco, CA – January 11, 2016 –Today Independence Blue Cross and NantHealth announced the nation’s first insurance coverage for a comprehensive whole genome and proteome molecular diagnostic platform (GPS Cancerä) to diagnose molecular alterations in an individual’s cancer, and to identify personalized therapeutic regimens. With today’s announcement, the application of precision medicine in the oncology setting has now emerged from research to the clinical cancer setting – a significant milestone in precision medicine and the war against cancer.
GPS Cancer is a CLIA-certified diagnostic test that combines whole genome sequencing of tumor-normal specimens together with RNA sequencing and quantitative protein analysis to identify the protein pathways active in the individual’s cancer. GPS Cancer is the nation’s first CLIA-certified comprehensive DNA/RNA test with quantitative proteomics to receive reimbursement coverage in the clinical setting. Sequencing the whole DNA of three billion base pairs with over 20,000 genes, as well as RNA to identify those mutated genes which express the proteins from a patient’s cancer, provides comprehensive and critical molecular information. Only through this comprehensive test can the physician more accurately identify which of the multitude of molecular alterations that are present in cancer cells translate to abnormal proteins being produced and which are the key targets for many therapeutic interventions. It is anticipated that the commercial launch of the GPS Cancer test will occur by March 2016.
“Independence Blue Cross is committed to bringing state-of-the-art advances in oncology to our members and making care accessible and affordable,” said Daniel J. Hilferty, President and Chief Executive Officer of Independence Blue Cross. “Decisions around cancer care are complex and personal. We’re focused on supporting Independence members and their oncologists by offering coverage for this innovative approach to treating cancer. Whole genome sequencing is one more option to help inform a personalized, effective treatment plan.”
Independence’s agreement with NantHealth involves a very specific and complex lab study related to cancer, next-generation whole genomic sequencing of tumor DNA, and related proteomic testing, for certain types of cancer. The test will be covered for members with specific conditions including rare cancers, tumors in children, metastatic cancer of unknown primary brain cancer, triple negative breast cancer, and metastatic cancer where conventional therapies have been exhausted and patients remain candidates for further therapy, including immunotherapy. Coverage for the testing will be available to eligible members of Independence commercial plans beginning in March 2016.
The GPS Cancer test includes a web-based clinical report that provides actionable patient-specific clinical information for the physician and patient at the point of care. NantHealth, which already offers the Eviti oncology decision support software, recently announced the addition of NaviNet Open, a payer-provider collaboration platform. The eviti clinical decision support platform facilitates determination of evidence-based protocols based on the molecular and clinical stage of the patient’s cancer. The NaviNet Open payer-provider collaboration platform enables doctors and payers to review information in real time. Taken together this NantHealth operating system now serves as a scalable, real-time access point and a portal for providers and patients to receive scientific, clinical and other information in real time about novel therapies and relevant clinical trials, all based on the results from the patient’s GPS Cancer test.
“The launch of GPS Cancer, together with coverage by a major payer serving with their affiliates 10 million people in 34 states, combined with the introduction of a collaboration and clinical decision support portal providing access to over 450,000 healthcare professionals for real-time communications and access to ground breaking clinical trials, and a multi-payer portal for over 100 million covered lives, collectively creates a healthcare collaboration network at national scale. This platform, we believe, will provide more effective treatment options for patients with cancer,” said Patrick Soon-Shiong, M.D., Founder and Chief Executive Officer of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine.
He added, “Utilizing the cloud-based system of NaviNet Open and eviti makes possible provider access to over 90% of covered lives in the United States and will serve as a transformative platform for the communication of cutting-edge clinical information in real time to all physicians and their patients in this nation as well as bring precision medicine in oncology from the research setting to clinical deployment today. Coverage of GPS Cancer by Independence Blue Cross enables NantHealth to begin the process of generating patient-specific clinical information that will improve the evidence base on which providers determine their treatment decisions.”
“At Independence, we are committed to transforming cancer care via an integrated, evidence-based, personalized approach that enables patients and their physicians to make better informed decisions,” said Don Liss, M.D., Vice President of Clinical Programs and Policy at Independence. “The science around genomics and immunotherapy and their potential to advance our approach to cancer care is evolving. Entering into a relationship with NantHealth, and supporting the Cancer Breakthroughs 2020 Program, are two ways that we can contribute to the evidence-base and – potentially – help to revolutionize our approach to cancer care.”
Robert Watson, President of NantHealth said, “The time is now right to bring the potential for precision medicine to cancer patients. With the launch of GPS Cancer and our agreement with Independence Blue Cross to provide coverage for NantHealth’s GPS Cancer test, we have set the stage to move from the bench-to-bedside to more rapidly begin the process of improving the health of patients with cancer.”
A CLIA/CAP tissue biorepository has been established at Windber Research Institute (WRI), a private non-profit biomedical research institute that has been established to manage the collection, processing, storage and distribution of all biospecimens for research and clinical applications. Tom Kurtz, CEO of Windber Medical Center and Windber Research Institute stated, “Windber was responsible for providing over 90% of the breast cancer tissue samples genetically analyzed by the NIH Cancer Genome Atlas study. Windber’s human tissue repository is the nation’s foremost Platinum-rated, CLIA/CAP certified biorepository for cancer tissue currently housing over 90,000 tissue specimens and will be utilized as the tissue repository resource for further research and clinical studies.”
About Independence Blue Cross
Independence Blue Cross is the leading health insurance organization in southeastern Pennsylvania. With our affiliates, we serve nearly 10 million people in 34 states and the District of Columbia, including 2.5 million in the region. For nearly 80 years, we have been enhancing the health and wellness of the people and communities we serve by delivering innovative and competitively priced healthcare products and services; pioneering new ways to reward doctors, hospitals, and other healthcare professionals for coordinated, quality care; and supporting programs and events that promote wellness. To learn more, visit www.ibx.com. Connect with us on Facebook at ibx.com/facebook and on Twitter at @ibx. Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association.
About NantHealth
NantHealth, a member of the NantWorks ecosystem of companies, is a transformational healthcare IT company converging science and technology through a single integrated clinical platform, to provide actionable health information at the point of care, in the time of need, anywhere, anytime. NantHealth works to transform clinical delivery with actionable clinical intelligence at the moment of decision, enabling clinical discovery through real-time machine learning systems. The company’s technology empowers physicians, patients, payers and researchers to transcend genomics into the world of proteomics and the traditional barriers of today’s healthcare system. By converging molecular science, computer science and big data technology the Nant Service Oriented Operating System (NantOS) platform empowers physicians, patients, and payers to coordinate best care, monitor outcomes and control cost in real time. This is the first operating system of its kind in healthcare that is based on supply chain principles and grid service oriented architecture and integrates the knowledge base with the delivery system and the payment system, enabling 21st century coordinated care at a lower cost. For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter @solvehealthcare.
About NantOmics
NantOmics, a member of the NantWorks ecosystem of companies, delivers molecular diagnostic capabilities with the intent of providing actionable intelligence and molecularly driven decision support for cancer patients and their providers at the point of care. NantOmics is the first molecular diagnostics company to pioneer an integrated approach to unearthing the genomic and proteomic variances that initiate and drive cancer, by analyzing both normal and tumor cells from the same patient and following identified variances through from DNA to RNA to protein to drug. NantOmics has a highly scalable cloud-based infrastructure capable of storing and processing thousands of genomes a day, computing genomic variances in near real-time, and correlating proteomic pathway analysis with quantitative multi-plexed protein expression analysis from the same micro-dissected tumor sample used for genomic analysis. For more information please visit www.nantomics.com and follow Dr. Soon-Shiong on Twitter @solvehealthcare.
About GPS Cancer
GPS Cancer is a CLIA-certified, comprehensive, panomics-based test that utilizes whole genome sequencing and RNA sequencing of a patient’s tumor, with the patient’s normal sample, to identify molecular alterations in the DNA and RNA of the patient’s tumor. Utilizing whole genome based sequencing of DNA and RNA provides vital clinical information on a cancer patient’s molecular alterations that are resulting in abnormal proteins, which are the important targets for many cancer drugs. RNA information also provides additional confidence that the identified changes that are unique to a patient’s cancer may be useful in selecting a therapeutic intervention specific for a patient’s cancer.
GPS Cancer is the most comprehensive CLIA certified molecular analysis platform of the tumor and normal sample, measuring DNA to RNA to Protein. This genomic and protein-based molecular diagnostic testing service and technology platform, to support personalized cancer care, is the first in the nation to receive insurance coverage. By combining the breadth of whole genome sequencing with the depth of well-validated analytical tools, this test enables the validation of gene (DNA) alterations by determining gene protein expression through RNA sequencing, complemented with the exactness of quantitative protein expression analysis.
Through the understanding of the totality of genomic mutations from whole genome and exome sequencing for the individual cancer patient, and by focusing on those mutations that are relevant (expressed at sufficient levels to impact disease) and real (not SNiPs or common germline variants), we gain the most accurate and comprehensive molecular information in order to inform the best choice of pharmaceutical agents to treat the patient. This is especially true in the generation of patient-specific immunotherapies including neoepitope targeting therapies.
GPS Cancer’s genomic analysis selects for relevant mutations including single nucleotide variances, copy number variances, insertions/deletions, and rearrangements by directly contrasting tumor genome sequence from normal genome sequence from each patient and by identifying the patient’s mutated genes that are expressed (thus vastly reducing false positive and negative rates associated with panel, tumor-only sequencing)—all of this analysis is performed on 50 um of Formalin Fixed Paraffin Embedded (FFPE) or fresh frozen samples and 2.5 cc of blood. Our quantitative proteomics platform enriches for proteins unique to tumor cells from a 20 um sample of FFPE preserved tissue via laser microdissection and measures absolute quantities of proteins relevant to targetedand chemotherapies using proprietary mass spectrometry analysis.