ARUP Laboratories has introduced a molecular test that it says can serve as a potential replacement for a colonoscopy when searching for suspected cases of colon cancer. The Septin 9 methylated DNA test, also known as Sept9, can detect even a minute amount of colon cancer cells in the bloodstream, ARUP officials said. The method has a 90 percent overall sensitivity and 88 percent specificity in detecting colorectal cancer at all stages—significantly higher than current fecal occult blood testing. Although ARUP currently performs the test only in house, a kit is currently being developed for Food and Drug Administration approval. It would likely drive significant sales—particularly if the assay is incorporated into clinical guidelines—said Karen Heichman, vice president in charge of ARUP’s oncology product development. A typical colonoscopy involves the insertion of a long tube into the digestive tract equipped with a miniature camera. The procedure usually requires general anesthesia and can cost $1,500 or more. Nevertheless, as many as 15 million of the procedures are performed in the United States every year, according to the National Comprehensive Cancer Network, with about 100,000 new cases of colon cancer diagnosed annually. Although medical guidelines recommend regular colon cancer screenings be undertaken […]
ARUP Laboratories has introduced a molecular test that it says can serve as a potential replacement for a colonoscopy when searching for suspected cases of colon cancer.
The Septin 9 methylated DNA test, also known as Sept9, can detect even a minute amount of colon cancer cells in the bloodstream, ARUP officials said. The method has a 90 percent overall sensitivity and 88 percent specificity in detecting colorectal cancer at all stages—significantly higher than current fecal occult blood testing.
Although ARUP currently performs the test only in house, a kit is currently being developed for Food and Drug Administration approval. It would likely drive significant sales—particularly if the assay is incorporated into clinical guidelines—said Karen Heichman, vice president in charge of ARUP’s oncology product development.
A typical colonoscopy involves the insertion of a long tube into the digestive tract equipped with a miniature camera. The procedure usually requires general anesthesia and can cost $1,500 or more. Nevertheless, as many as 15 million of the procedures are performed in the United States every year, according to the National Comprehensive Cancer Network, with about 100,000 new cases of colon cancer diagnosed annually.
Although medical guidelines recommend regular colon cancer screenings be undertaken by individuals over the age of 50, ARUP officials noted that because of the price and invasiveness of the procedure, about 40 million Americans at risk of developing the disease are left unscreened every year.
“This test ensures that everyone, even our special populations, has an option for colorectal cancer screening,” said Edward Ashwood, M.D., ARUP’s chief executive officer.
However, the test does have its limitations. Heichman noted that the test is “not very sensitive” for detecting precancerous lesions that can be pinpointed during a colonoscopy and removed. And if the Sept9 results in a positive test, the patient would likely undergo a colonoscopy anyway.
ARUP does not set the pricing for the test, instead deferring to its client hospitals and clinics. The CPT code for the test is 81401, a tier 2 molecular pathology procedure, which may be billed to Medicare using the interim HCPCS add-on code G0452 introduced in late 2012.
