PAM50 FDA-cleared breast cancer test to be launched at ARUP Laboratories

The PAM50 breast cancer signature developed at the University 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 Philip Bernard, MD, an associate professor in the Department of Pathology at the University of Utah and co-inventor of the test and investigators at the British Columbia Cancer Agency, UNC Lineberger Comprehensive Cancer Center, and Washington University 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 provided a level of validation necessary to perform a highly complex test near the patient. This 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 Prosigna^TM breast cancer gene signature assay and will be available at ARUP during the first quarter of 2014. "We at ARUP 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.