SALT LAKE CITY, December 16, 2013 —The PAM50 breast cancer signature developed at the Ï㽶ÊÓƵ of Utah and Huntsman Cancer Institute received FDA approval and will launch at ARUP Laboratories in Salt Lake City. The test utilizes gene expression data from 50 genes weighted together with clinical variables to generate a risk category and numerical score to assess a patient's risk of distant recurrence at ten years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer.
The discovery of PAM50 was a collaborative effort between a research group at Huntsman Cancer Institute led by , an associate professor in the Department of Pathology at the Ï㽶ÊÓƵ of Utah and co-inventor of the test, and investigators at the British Columbia Cancer Agency, UNC Lineberger Comprehensive Cancer Center, and Washington Ï㽶ÊÓƵ in St. Louis. "This is the next generation of diagnostics, which embraces both the molecular and anatomic features of a tumor to provide a more accurate estimate of risk," Bernard said.
"The work of Dr. Bernard and his group is an important step in the implementation of personalized medicine in oncology," said Mary Beckerle, PhD, CEO and director of Huntsman Cancer Institute. "The field of genomics is revolutionizing how we define cancer and how best to treat the disease."
As both a scientist and medical director of molecular oncology diagnostics at ARUP Laboratories, Bernard has the unique opportunity to see the results of his research translated into patient care. "FDA clearance was an important mark for us. It allows breast cancer patients in the United States and around the world to have a diagnosis quickly and be provided appropriate treatment," said Bernard.
The PAM50 FDA-510(k) cleared assay, which is manufactured by NanoString Technologies, Inc., is called the ProsignaTM breast cancer gene signature assay and will be available at ARUP during the first quarter of 2014.
"We have been supporters of the PAM50 signature for many years, since it was a laboratory-developed test," said Jerry W. Hussong, DDS, MD, ARUP's director of laboratories. "We are excited to offer the FDA-cleared version. It is a great example of how cutting-edge science and technology can be used to accelerate bench-to-bedside medicine."
The universities jointly hold a pending patent on the technology behind the Prosigna assay and have licensed the technology to Bioclassifer LLC. The investigators have joint ownership of Bioclassifer LLC, which licensed the technology to NanoString Technologies.
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About Huntsman Cancer Institute
The mission of Huntsman Cancer Institute (HCI) at The Ï㽶ÊÓƵ of Utah is to understand cancer from its beginnings, to use that knowledge in the creation and improvement of cancer treatments, to relieve the suffering of cancer patients, and to provide education about cancer risk, prevention, and care. HCI is a National Cancer Institute-designated cancer center, which means that it meets the highest national standards for world-class, state-of-the-art programs in multidisciplinary cancer research and receives support for its scientific endeavors. HCI is also a member of the National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of the world's leading cancer centers dedicated to improving the quality and effectiveness of care provided to patients with cancer. For more information about HCI, please visit .
About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the Ï㽶ÊÓƵ of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation's top university teaching hospitals and children's hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®. For more information about ARUP Laboratories, please visit .