ARUP announces new version of Septin 9 methylated DNA test

ARUP Laboratories, a leading national clinical and anatomic pathology reference laboratory and a leader in innovative laboratory research and development, today announced it is offering the Septin 9 methylated DNA test, a new blood-based colorectal cancer screening method. While ARUP is not the first laboratory to offer this test, this new version, developed and validated independently by ARUP, is clinically proven to detect a higher proportion of colorectal cancers than Septin 9 tests developed by other companies.

“While we are confident in the quality and accuracy of our test, we encourage physicians and patients to follow national screening guidelines”

"The value of the Septin 9 test to physicians in detecting and treating colorectal cancer cannot be overstated," said Sherrie Perkins, MD, PhD, ARUP's chief medical officer and director of laboratories. "Research has shown that half of the population that should be screened is actually being screened. This blood-based test makes the screening easier and less invasive for patients. The test can be performed on specimens collected in the doctor's office without preparation by the patient, without the time commitment of an endoscopy or the need to handle and mail one's stool as part of a fecal test. Our test is more sensitive than any other on the market; we are able to identify nine out of 10 people with previously undetected colorectal cancer, including those with early stage disease."

According to the American Cancer Society, colorectal cancer is the third most common cancer and third leading cause of cancer death among men and women in the U.S. When detected in early stages, survival rates for colorectal cancer exceed 90 percent. Currently 40 to 50 million Americans who should be screened for colorectal cancer are not following the recommendation that all people age 50 and older undergo testing.

"While we are confident in the quality and accuracy of our test, we encourage physicians and patients to follow national screening guidelines," said Perkins. "This test is designed primarily for patients who cannot or will not undergo the established screening methods; it is not meant to replace colonoscopy. Physicians should take steps to further evaluate patients with a positive Septin 9 test result."

ARUP Laboratories was one of three independent labs that participated in the PRESEPT study, a nearly 8,000 subject prospective study of the screening population which validated Septin 9 as a sensitive blood-based biomarker of colorectal cancer. PRESEPT was sponsored by Epigenomics AG, and conducted under the direction of an independent clinical study steering committee. Preliminary results of the study were recently presented at the 2010 Digestive Disease Week this spring, with publications anticipated in the near term.

ARUP Laboratories licensed the Septin 9 biomarker from Epigenomics AG in August 2009 in order to develop and commercialize a blood-based colorectal screening test. Berlin- and Seattle-based Epigenomics AG is a molecular diagnostics company focusing on the development and commercialization of in vitro diagnostic tests for cancer.

The Septin 9 methylated DNA test will be offered to clients through ARUP's test menu beginning July 19, 2010.