August 14th, 2014
10:12 AM ET
New at-home test may detect colon cancer
The U.S. Food and Drug Administration has approved an at-home colon cancer test. Called Cologuard , it is the first stool-based screening test that detects certain DNA mutations and red blood cells that could be indications of colorectal cancer, according to the FDA. The test, which is ordered through a doctor's office, can be done at home.
"Unlike many other screening options, Cologuard does not require medication or dietary restrictions, or bowel preparation prior to taking the test," the manufacturer says.
The FDA says Cologuard could be used to help determine who is at risk of developing colorectal cancer at its earliest stages when the cancer is still asymptomatic. The agency approved the test this week.
Most cases of colorectal cancer begin as small polyps attached to the walls of the large intestine or rectum. Colorectal cancer primarily affects men and women over the age of 50. And in most situations it is preventable. If caught in time, the FDA says at least 60% of colorectal cancer deaths could be avoided.
The new stool-based test detects certain abnormalities associated with colorectal cancer cells. Patients who test positive with Cologuard would be advised to undergo further tests, including a colonoscopy.
"This approval offers patients and physicians another option to screen for colorectal cancer," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health. "Clinical data showed that the (new) test detected more cancers than a commonly used fecal occult test."
Fecal occult blood tests, or fecal immunochemical tests, are previously approved screening tests that can be done once a year at home. The American Cancer Society recommends people with an average risk for colorectal cancer also have a flexible sigmoidoscopy every five years or a colonoscopy every 10 years.
Although it adds another method for detecting some cases of colorectal cancer, the new at-home test has both pros and cons, says Dr. Won Kyoo Cho, chief of gastroenterology/hepatology at MedStar Washington Hospital Center in Washington.
"When it comes to spotting more abnormalities the test is very good. The Cologuard picks up about 92.3% of abnormalitites, compared to 74% with the FIT (fecal immunochemical test)."
But Cho warns, "The downside is the new test was not as good at finding 'true negatives.' ” Cologuard correctly identified a negative result in 87% of patients, the FDA says; the fecal immunochemical test correctly identifies negative results about 95% of the time.
"That means you may be picking up abnormalities, but it doesn't necessarily mean those abnormalities are cancerous, so the false positives are higher," Cho says. "Many people who test positive on the test may be worried for no reason."
The approval of Cologuard does not mean current colorectal cancer screening guidelines have changed. The FDA notes that stool DNA testing is not currently recommended to screen for colorectal cancer by the U.S. Preventive Services Task Force. The task force still believes patients between the ages of 50 to 75 should be screened using fecal occult blood testing, a sigmoidoscopy or a colonoscopy.
A colonoscopy is the "gold standard" in colorectal cancer detection.
"(Cologuard) doesn't really detect polyps that could be the beginning of colon cancer," Cho said. "When you go in with a colonoscopy, you can snip those polyps out immediately. Done. But if you miss those polyps and they grow in the colon, you could be facing serious surgery, or even the possible spread of the cancer."
At this point, the main issue with Cologuard is cost. According to Cologuard's manufacturer, one test costs as much $600. But the FDA noted on the same day of the test's approval, the Centers for Medicare and Medicaid Services issued a proposed national coverage, meaning Medicare will pay for the test once every three years for beneficiaries who meet a certain criteria.
"This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day," said Patrick Conway, chief medical officer and deputy administrator for innovation and quality for the Centers for Medicare and Medicaid Services. "This parallel review ... will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer."
Cho adds, "The fecal tests we use now cost as little as $20, which means you can afford to have one done every year. But hundreds of dollars - no wonder Medicare will only pay for it every three years."
About this blog
Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.
You've made some good points there. I checked on the net for more information about the issue and found most individuals will go along with your views on this website.
canadian pharmacy viagra Canadian Health Care Cost viagra for sale in canada
An outstanding share! I've just forwarded this onto a co-worker who had
been doing a little homework on this. And he in fact bought me breakfast because I discovered it for him...
lol. So allow me to reword this.... Thanks for the meal!!
But yeah, thanks for spending time to discuss this issue here
on your web page.
maxifort zimax 100 mg maxifort 50 mg
Viraj produces Stainless Steel welding cables used for welding purpose in Fabrication, Chemical, Automotive, Oil & Gas, Railways & various other industries.
At this kind of rate, you can debut as a copy writer. Now i am so touched. Now i'm happy to meet you. Appreciate you.
healthy man viagra
buy single viagra pills uk 369 North West Pharmacy free viagra sample before buying
maxifort online maxifort zimax mexico
best western plus casino royale las vegas https://casinoxsgames.com/ casino free slots
It is a lot more than possible to invest all your time researching Technology and below is something which will permit you to take all the facts you need that are one of the most pertinent to your objectives. If you would love to get excellent results that really issue, you can not delay the necessary actions. In the event that you aren't clear concerning a information or more, return and consider it once more or ask a person who you count on. You don't want tiny issues to hold you down. Among the places you can go when you want to find out more is Our Technology Site, which has aided a lot of people who are where you are.
healthy man cialis
It's genuinely very difficult in this busy life to listen news on Television, so I simply use the web for
that purpose, and get the most up-to-date news.
maxifort online maxifort zimax sildenafil 50 mg
It is so essential, possibly vital, for you to have actually a option oriented approach when working with Technology. Without a doubt, countless individuals are currently achieving this, yet taking care of Technology is not the easiest matter on this planet. Anybody that requires assistance with this ought to definitely visit Our Technology Site to obtain additional support in addition to recommendations.
Customers large as well as little, turn to Airgas to give the very best Filler Metal products for industrial, industrial, research laboratory and work environment atmospheres.
buy non prescription viagra online Click Here cheap generic viagra
Good info. Lucky me I came across your blog by chance (stumbleupon).
I've book marked it for later!
If you're keen on making Technology something that is worthwhile for you, the methods we've provided will certainly assist. It typically is preferable to see quick results, yet to do so, you require to have perseverance if they don't show up right away. Anytime you need extra support, you'll intend to head over to Our Technology Site – bookmark this url so you have it for future recommendation.
It is a whole lot more than feasible to spend all your time researching Technology as well as right here is something which will permit you to gather up all the realities you need that are the most significant to your goals. If you wish to obtain great results that truly issue, you can't avoid the crucial steps. In case you aren't clear concerning a detail or more, go back as well as take a look at it again or ask a individual that you depend on. You do not desire small troubles to hold you down. Among the locations you can go when you wish to learn more is Our Technology Site, which has assisted a lot of individuals that are where you are.
Thank a person so much to get permitting myself know what We didn't know. I count on working with you.
Hey there! I simply would like to offer you a huge thumbs up for the excellent information you've got right here on this post. I'll be coming back to your web site for more soon.
maxifort zimax mexico maxifort 50 mg
Best view i have ever seen !
cheap viagra canadianhealthandcaremallreviews.com supreme suppliers viagra
buy maxifort maxifort zimax 100mg
Hi there! I just would like to give you a huge thumbs up for your great information you have right here on this post. I will be coming back to your blog for more soon.
I blog quite often and I really appreciate your information. The article has truly peaked my interest. I will bookmark your site and keep checking for new details about once a week. I subscribed to your RSS feed as well.
cheap generic viagra lowest prices My Canadian pharcharmy Online viagra for men at wholesale prices
canadian pharmacy cialis 20mg
maxifort zimax 100 mg maxifort zimax 100 mg
Just bookmarked this blog post as I have actually found it quite helpful.
Love the way you cover this topic.
Clients huge and tiny, count on Airgas to give the very best Filler Metal products for industrial, industrial, laboratory and also workplace settings.
buy maxifort maxifort zimax sildenafil 50 mg
Wonderful article! We are linking to this great content on our website. Keep up the great writing.
canadian pharmacy cialis
maxifort zimax 100mg maxifort zimax 100mg
buy maxifort maxifort online
maxifort zimax sildenafil 50 mg maxifort 50 mg
healthy man pills
pharmacy rx one review canadian pharmacy