| [November 29, 2016] |
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Chan Soon-Shiong Biobank at Windber Receives CLIA Certification from the Centers for Medicare and Medicaid Services
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."
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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 www.nantworks.com
and follow Dr. Soon-Shiong on Twitter (News - Alert) @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 www.cancermoonshot2020.org 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 www.gpscancer.com and www.cancermoonshot2020.org.
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 (News - Alert) 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 http://www.wriwindber.org/about-cssimmw.
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