The CLIA certification and CAP accreditation ensures the highest quality test results from the NantOmics lab to help improve cancer outcomes and will support the Cancer Breakthroughs 2020 mission in its war on cancer
CULVER CITY, Calif. – April 19, 2016 – NantOmics, LLC, the leader in molecular diagnostics and member of the NantWorks ecosystem of families, today announced that its laboratories have been certified by the U.S. Department of Health and Human Services' Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Acts (CLIA) of 1988, and has been accredited by the College of American Pathologists (CAP). As the nation’s first and only CLIA-certified, CAP-accredited laboratories to perform whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics—all in one comprehensive test—today’s announcement exemplifies the highest quality standard delivered by NantOmics to ensure accuracy, reliability, and timeliness of patient test results.
“The approval by the CLIA and CAP regulatory organizations provides the analytic validity of the laboratories to perform our molecular diagnostic test, GPS Cancer™, and provides the catalyst to dramatically change the current paradigm of cancer care by bringing the promise of 21st century precision medicine to cancer patients today,” said Shahrooz Rabizadeh, chief scientific officer of NantOmics. “Clinicians utilizing this comprehensive test will have the assurance that the test results will be reliable and of the highest quality.”
The CLIA and CAP programs regulate laboratories that test patient specimens to ensure accurate and reliable test results are produced in addition to helping laboratories achieve the highest standards of excellence to positively impact patient care.
“Novel cancer immunotherapies, combination therapies and other investigational therapies that can harness the power of the patient’s own immune system are the path to winning the cancer war,” said Dr. Patrick Soon-Shiong, CEO of NantHealth, which will commercially launch GPS Cancer in market later this year. “The ability for GPS Cancer to perform whole genome sequencing, RNA sequencing and quantitative proteomics—in a CLIA-certified, CAP-accredited lab—underscores the high-quality and reliability needed to understand a patient’s biology, and marks a significant milestone for the Cancer Breakthroughs 2020 program’s mission to win the war against cancer.”
About GPS Cancer
GPS Cancer™ is a first-of-its-kind, comprehensive test available through NantHealth. GPS Cancer integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics, providing oncologists with a comprehensive molecular profile of a patient’s cancer to inform personalized treatment strategies. GPS Cancer testing is conducted in the CLIA-certified, CAP-accredited laboratories of NantOmics, and is a key enabler for the Cancer Breakthroughs 2020 program, the nation's most comprehensive cancer collaborative initiative seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients.
About CAP accreditation: What does it mean to be CAP-accredited?
The College of American Pathologists (CAP), the leading organization of board-certified pathologists, serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.
CAP's Laboratory Accreditation Program is widely recognized as the 'gold standard' and has served as a model for various federal, state, and private laboratory accreditation programs throughout the world.
Its inspection program is internationally recognized and the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards.
About CLIA certification: What does it mean to be CLIA-certified?
The Clinical Laboratory Improvement Amendments (CLIA) establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
CLIA specifies quality standards for proficiency testing (PT), patient test management, quality control, personnel qualifications and quality assurance for laboratories performing moderate and/or high complexity tests.
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 @DrPatSoonShiong.
NantHealth, a member of the NantWorks ecosystem of companies, is a transformational company converging the power of genomic science and healthcare IT through a highly scalable cloud-based platform, to provide actionable health information at the point of care. 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 @DrPatSoonShiong.
About Cancer Breakthroughs 2020
The Cancer Breakthroughs 2020 Program is the nation's most comprehensive cancer collaborative initiative seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. This initiative aims to explore a new paradigm in cancer care by initiating randomized Phase II trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and the aspirational Breakthroughs to develop an effective vaccine-based immunotherapy to combat cancer by 2020. For more information, visit http://www.CancerBreakthroughs2020.org.