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Chan Soon-Shiong Biobank at Windber Receives CLIA Certification from the Centers for Medicare and Medicaid Services

Posted on: 29 Nov 16

Chan Soon-Shiong Institute of Molecular Medicine at Windber, a private, non-profit biomedical research institute, today announced that the Chan Soon-Shiong Biobank at Windber (CSSBW) has been certified by the U.S. Department of Health and Human Services' Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Acts of 1988 (CLIA). This certification follows the accreditation by the College of American Pathologists (CAP) in 2015, rounding out the most important third-party validation within the industry for laboratories. With over 15 years of expertise within the industry and over 200,000 specimens representing blood components, different tissue types, DNA and RNA stored in the biorepository, today’s announcement ensures that CSSBW has the appropriate authority to handle and test human samples collected from clinical trials within the Cancer MoonShot 2020 initiative.

“At CSSBW, we pride ourselves in providing high quality biospecimens to enhance the scope and reliability of molecular research; having CLIA certification secures us the upmost authority to handle specimens gathered from Cancer MoonShot 2020 clinical trials,” said Stella B. Somiari, PhD, senior director at CSSBW. “We are thrilled to be the national biobank for Cancer MoonShot 2020 to support its efforts in combatting cancer. Managing the biospecimen collection, storage and processing for Cancer Moonshot 2020 guarantees the team will gather and treat specimens that represent the right disease states, yielding accurate results from experimentation and research.”

Under the U.S. Department of Health and Human Services' Centers for Medicare & Medicaid Services, the CLIA program regulates laboratories that test patient specimens to ensure accurate and reliable results are produced. CLIA-certification and CAP-accreditation allows CSSBW to begin collecting, processing, storing, testing and distributing samples performed on the GPS Cancer™ test.

“We are excited to have Chan Soon-Shiong Biobank at Windber as the national biobank for Cancer MoonShot 2020,” said Patrick Soon-Shiong, MD, founder and CEO of NantWorks and founder of the Cancer MoonShot 2020 program. “CLIA certification not only gives the biobank the authority to handle samples performed on GPS Cancer, but it also ensures that these samples are kept at the highest quality in order to provide true reflections of the patients’ conditions, which is essential for us to win the war on cancer.”

CSSBW will serve as the national biobank for Cancer MoonShot 2020, providing resources for specimen procurement, processing, storage, testing, research and distribution. This partnership provides support for Cancer MoonShot 2020’s satellite clinical trials from which samples will be collected and shipped to the biobank. As the national biobank for the initiative, CSSBW will guarantee that all required procedures are in place to ensure the highest quality of biospecimens used for cancer research.

About CLIA certification
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.

About NantWorks
NantWorks, LLC, founded by renowned physician scientist and inventor of the first human nanoparticle chemotherapeutic agent Abraxane®, Dr. Patrick Soon-Shiong, is the umbrella organization for the following entities: NantHealth, NantMobileHealth, NantOmics, NantBio, NantCell, NantPharma, NantCapital and NantCloud. Fact-based and solution-driven, each of NantWorks’ division entities operates at the nexus of innovation and infrastructure. The core mission of NantWorks is convergence and a systems approach to human biology: to develop and deliver a diverse range of technologies that accelerates innovation, broaden the scope of scientific discovery, enhance ground-breaking research, and improve healthcare treatment for those in need. NantWorks is building an integrated fact-based, genomically and proteomically -informed, personalized approach to the delivery of care and the development of next generation diagnostics and therapeutics for life threatening diseases such as Cancer, Infectious Diseases and Alzheimer’s. For more information, please visit and follow Dr. Soon-Shiong on Twitter @DrPatSoonShiong.

About Cancer MoonShot 2020
The Cancer MoonShot 2020 program is one of the most comprehensive cancer collaborative initiative launched to date, 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 moonshot to develop an effective vaccine-based immunotherapy to combat cancer by 2020. For more information, please visit and follow @MoonShot2020 on Twitter.

About GPS Cancer™
GPS Cancer™ is a unique, molecular profile analysis available through NantHealth. GPS Cancer integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics through mass spectrometry, providing oncologists with a comprehensive molecular profile of a patient’s cancer and an assessment of protein pathway function to inform personalized treatment strategies. GPS Cancer scanning is conducted in CLIA-certified and CAP-accredited laboratories, and is a key enabler for Cancer MoonShot 2020, the world’s most comprehensive cancer collaborative initiative seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. For more information, visit and

About Chan Soon-Shiong Institute of Molecular Medicine at Windber
The Chan Soon-Shiong Institute of Molecular Medicine at Windber (CSSIMMW) is a private, non-profit biomedical research institute established in 2000 as the Windber Research Institute. The institute has state-of-the art laboratories for Genomics, Translational Breast Cancer research and Cell Biology. All research activities are supported by a robust Biobank and Biomedical Informatics platform. The Biobank manages the collection, processing, storage and distribution of all biospecimens for research and operates as a College of American Pathologists (CAP) accredited biobank. The Biomedical Informatics Program conducts bioinformatics research and provides a data tracking system and Data Warehouse to support data management and integration for translational research. The research at CSSIMMW has strong clinical input from our collaborators at the Walter Reed National Military Medical Center in Bethesda, Maryland. For more information, please visit

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Last updated on: 29/11/2016

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