Cologuard, the brainchild of Exact Sciences, is a relatively new product making headlines in the wake of a report by the Associated Press’ Chief Medical Writer, Marilynn Marchione. While first cleared by the FDA in August, it appears not to have been making headlines for a time despite the potential to conduct colon cancer screening non-invasively, at home. While it is not recommended to rely solely upon its use, the kit will detect DNA markers indicating colon cancer in stool samples. Due to the youth of the product, there is not enough raw data to earn it specific endorsement. It is, however, a promising example of what the future may hold in store.
Though not yet cleared through the Preventative Services Task Force, a United States organization which advises on screening and testing procedures, initial research seems to indicate a fair level of effectiveness. A large study of over 10,000 cases showed that Cologuard found colorectal cancer 92 percent of the time when checked against a positive control, along with 42 percent of advanced precancerous growths. Compared against earlier testing procedures (which came in at 74 and 24 percent in the same tests, respectively), the home cancer screening kit seems very impressive and worthy of the headlines it’s currently making.
The ultimate determining factor in Cologuard’s success will be whether results show that use of the kit prevents more deaths through detection than it facilitates by providing people a level of comfort that could potentially dissuade people from making recommended appointments for traditional colonoscopies. Colonoscopy is still the best technique in the medical arsenal for detecting colorectal cancer, and all people over the age of 50 are advised to have one at least once every ten years, though many do not because of the arduous nature of the procedure.
Colon cancer is the third most diagnosed cancer in the U.S. and the second leading cause of related death, making home screening at least preferable to none. The average person has a 5 percent chance of developing colon cancer over the course of their lifetime. 90 percent of new cases of colon cancer, and 95 percent of deaths attributed to it, occur in people over the age of 50, and there are currently over one million survivors in America today.
When detected in its earliest stages, patients have a 90 percent chance of survival. If the cancer has spread enough to be considered “regional”, the likelihood of beating it drops to 70 percent, and if allowed to spread throughout the body, the prognosis of outliving the disease drops to 12 percent. This shows that the timeliness of detection is likely the single best advantage that a patient can gain in their fight.
The Cologuard kit requires the user to take a stool sample and send it in to Exact Sciences, the manufacturer’s laboratory, for analysis. What is different and unique with this test is that DNA in the sample will be analyzed for markers indicating the presence of polyps, where other similar tests sought trace amounts of blood that might indicate a tumor. The analysis of DNA in this home screening method provides it with higher accuracy and an earlier detection capability, which is why it still has the potential to earn a recommendation and make headlines as an effective alternative for cancer prevention at this time. However, the cost is still going to be prohibitive to many, as Cologuard is priced at $599. Perhaps, if it proves over time to significantly improve patient outcomes, insurance companies would adapt to cover this type of screening, or after the initial development costs, market forces could drive it back within a range more affordable for average Americans. The CMS, Medicaid and Medicare’s governing body, has proposed to cover the test under medicare. Though the status of that proposal was unclear at the time this report was written, for now at least, this promising development seems still to be a step in the right direction.
By Brian Whittemore
Photo Courtesy of U.S. Army – flickr License
Inset Photo by Ed Uthman – flickr License