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.
canadian 24 hour pharmacy
where to buy nizagara
viagra on line pharmacy viagra phizer
pfizer viagra canada pharmistry https://canadaviagrastore.com/ is it illegal to by viagra from canada
canadian pharmacies ed pills https://canadapillstorex.com/ canadian weight loss pills
supreme suppliers mumbai canadian pharmacy no prescription 24 hour canadian pharmacy supreme suppliers mumbai 400 058 india free samples of cialis sold in the usa northwest pharmacy canada supremesuppliers fda approved canadian online pharmacies North West Pharmacy best ed pills to take tretinac kaufen
canada pharmacy 24h
order cialis without prescription generic cialis without prescription
canadian pharmacy nizagara
viagra brand canada pharmacy online viagra for men at wholesale prices
I have been exploring for a little bit for any high quality articles or weblog posts in this sort of space . Exploring in Yahoo I finally stumbled upon this site. Studying this information So i am satisfied to express that I have an incredibly excellent uncanny feeling I came upon just what I needed. I so much indisputably will make sure to do not disregard this site and give it a look regularly.
supreme suppliers in india canadian pharmacy without prescritption canadian 24 hour pharmacy supreme suppliers viagra cialis free samples list of legitimate canadian pharmacies online pharmacy canadian pharmacy no prescription Canadian Health Care Cost best erectile dysfunction drugs for sale online tretinoin 20 20 gm from india
High rep C&P is a strong exercise but may be difficult do having a barbell.|Person will regarded top 5 fantasy football QB who are only next holiday season. Get going, with implausible prospects getting well-known on the inside world of football! If you deadlift in good form, you're fine.|The football draw game – hard to come by liverpool vs man city them don't you think so? But, most coaches focus on 40-speed when in reality increasing football game speed is the true secret. Now it has developed up as a great small business.|But, for many guys, this might be in far more than 700-lbs.In addition to these not being big ticket items, do supporters really want these football fundraising tips and hints?|However, you are not satisfied with the collection of merchandises an individual have.For example, the "E" Bell rings whenever Navy beats Army in any of the three seasons of training.|Therefore if they play inside, they're going to have to create football field very manageable.In the following practices select the tempo up and evaluate them once again.|A team that has internal problems and conflicts has chances of failure. Nowadays, people have access to information from anywhere they request. Now you have to look at the forthcoming matches and compare the teams' ratings.|Over 24 years of coaching youth football.
cheap cialis no prescription generic cialis without prescription
buy viagra online uk online pharmacy viagra muy barata
chloroquine https://chloroquineorigin.com/ is chloroquine phosphate the same as hydroxychloroquine
High rep C&P is an unique exercise occasionally be harder to do by using a barbell.|This guy will be a top 5 fantasy football QB as soon as next months. Get going, with implausible prospects getting well-known globe world of football! Should you deadlift in good form, you're fine.|The football draw game – difficult to acquire lịch la liga them don't you think? But, most coaches concentrate on 40-speed when in reality increasing football game speed is the crucial element. Now it has developed up like a great corporate.|But, for most guys, this might be in far more than 700-lbs.In addition to these not being big ticket items, do supporters really would like these football fundraising ideas?|However, you aren't satisfied the actual use of collection of merchandises you have.For example, the "E" Bell rings whenever Navy beats Army in most of the three seasons of exercise.|Therefore if they play inside, they'll have to inside the football field very manageable.In the following practices purchase the tempo up and evaluate them once again.|A team that has internal problems and conflicts has chances of failure. Nowadays, people have access to information from anywhere they have to have. Now you'll want to look at the forthcoming matches and compare the teams' ratings.|Over 24 years of coaching youth football.
where to buy sildenafil 100mg https://eunicesildenafilcitrate.com/ sildenafil over the counter usa
Today, I went to the beachfront with my kids. I found a sea shell and gave it to my 4 year old daughter and said "You can hear the ocean if you put this to your ear." She placed the shell to her ear and screamed. There was a hermit crab inside and it pinched her ear. She never wants to go back! LoL I know this is totally off topic but I had to tell someone!
I was wondering if anyone knows what happened to Dime Piece LA celebrity streetwear brand? I seem to be unable to proceed to the checkout on Dimepiecela site. I've read in Marie Claire that they were acquired by a UK-based hedge fund for $50 million. I've just bought the Dimepiece Hotel Unisex Heavy Blend™ Crewneck Sweatshirt from Ebay and totally love it xox
May I simply say what a comfort to uncover somebody who really understands what they're talking about on the internet. You definitely realize how to bring an issue to light and make it important. More and more people should read this and understand this side of your story. It's surprising you are not more popular given that you certainly have the gift.
supremesuppliers canadian pharmacies online pharmacy supremesuppliersindia.com cialis free samples canadian pharmacies mail order online pharmacy canadian pharmacy online no script canadian health and care mall generic ed meds retin a without a prescription
northwest pharmacy canada
maxifort 50 mg maxifort zimax 100 mg
Your style is so unique in comparison to other folks I've read stuff from. I appreciate you for posting when you have the opportunity, Guess I will just book mark this web site.
I appreciate the way you have ended this post ...
sex pills like viagra 294 online pharmacy viagra very fast shipping
sildenafil citrate women https://eunicesildenafilcitrate.com/ sildenafil 20mg prescription cost
Good post. I learn something new and challenging on websites I stumbleupon every day. It's always useful to read articles from other writers and practice a little something from their websites.
canadian pharmacy no prescription online pharmacy canada pharmacy online supremesuppliersindia.com cialis free samples best pharmacy in canada supreme suppliers generic viagra online canadian pharmacy canadianhealthandcaremallscam.com ed generics online no prescription tretinoin
maxifort zimax 100mg maxifort
canadian pharmacy clonidine
They can make researches and studies regarding each game and its players. Watch them closely during team drills when you have to work together with other players. This is a perfect football strength exercise.|Try reading up these as well as apply these types of your own online football betting. When making bets,bayern munich chuyển nhượng you can't ever be sure that you will win every single bet you make. This bell sits in front of Bancroft Hall in Annapolis.|By adding chains or bands, you can use a small bag but work the legs and back even harder. You can easily get online and look great reason websites offering this active service. These games are patterned after American Football.|Dominate the clock and possess a better chance of success. The higher priced football fundraisers that are sold, receive more money per on sale.
Superb blog! Do you have any hints for aspiring writers? I'm hoping to start my own blog soon but I'm a little lost on everything. Would you recommend starting with a free platform like WordPress or go for a paid option? There are so many choices out there that I'm totally overwhelmed .. Any ideas? Thank you!
canadian pills pharmacy https://canadapillstorex.com/ canadian customs pills vitamins
chloroquine phosphate tablet https://aralenchloroquinex.com/# chloroquine tablet
Just bookmarked this article as I have found it rather handy.
They can make researches and studies regarding each game and its players. Watch them closely during team drills when they have to work in tandem with other players. This is a perfect football strength exercise.|Try reading up these as well as apply them to your own online football betting. When making bets,hlv bayern munich buying a be sure that you will win each bet in which you make. This bell sits in front of Bancroft Hall in Annapolis.|By adding chains or bands, you should use a moderate bag but work the legs and back even harder. You can easily get and also look fresh air and good websites offering this service. These games are patterned after American Football.|Dominate the clock and you could have a better chance of success. The higher priced football fundraisers that are sold, add more money per produced.
They help make researches and studies regarding each game and its players. Watch them closely during team drills when these people work in tandem with other players. This is a perfect football strength exercise.|Try reading up these tips and apply them to your own online football betting. When making bets,thông tin clb chelsea you can't ever be without you will win all bet a person simply make. This bell sits in front of Bancroft Hall in Annapolis.|By adding chains or bands, you should use a smaller sized bag but work the legs and back even harder. You can easily get as well as look for good websites offering this care. These games are patterned after American Football.|Dominate the clock and own a better chance of success. The higher priced football fundraisers that are sold, pull in more money per sale made.
cheap viagra pills free shipping on line pharmacy dove comprare viagra
buy cialis without prescription price on cialis 5mg no prescription