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."

soundoff (2,121 Responses)
  1. Dominick Calkins



    April 16, 2021 at 19:18 | Report abuse | Reply
  2. LeroyUsese

    buy viagra online without prescription

    April 16, 2021 at 21:09 | Report abuse | Reply
  3. 우리카지노

    You ought to take part in a contest for one of the finest sites on the internet. I am going to highly recommend this website!


    April 16, 2021 at 21:49 | Report abuse | Reply
  4. CharlesEloff

    viagra witout a prescription impotence medication cheap cialis no prescription canada pharmacy canadian pharmacies online clomiphene canada pharmacy online canadian health and care mall canadian pharmacy online cialis best site buy viagra online

    April 17, 2021 at 00:17 | Report abuse | Reply
  5. 우리카지노

    You made some good points there. I checked on the internet for additional information about the issue and found most people will go along with your views on this site.


    April 17, 2021 at 01:42 | Report abuse | Reply
  6. Heathsap

    sky pharmacy online drugstore

    April 17, 2021 at 05:18 | Report abuse | Reply
  7. trực tiếp ngoai hang anh 2018

    Go department! bang xep hang bong da anh Sports memorabilia fans are lucky! There are many and varied articles and apparel available for an eager football fan. He/she can watch Sunday football wearing a popular team jacket. Whether you choose to watch professional football games live, with fellow enthusiasts for just a favorite sports bar, quite possibly the convenience your home in front of that big screen TV, wearing your team's logo is the right way to exhibit team loyalty and advertise that you are an avid fan to render it in with the comfort inside of their home.


    April 17, 2021 at 05:51 | Report abuse | Reply
  8. Denice Crooks

    Hey There. I found your blog using msn. This is an extremely well
    written article. I will be sure to bookmark it and come back to read
    more of your useful information. Thanks for the post. I'll certainly comeback.

    April 17, 2021 at 11:37 | Report abuse | Reply
  9. BrucePaumn

    cialis without prescription name brand cialis without prescription

    April 17, 2021 at 12:13 | Report abuse | Reply
  10. CharlesEloff

    viagra no prior prescription medications for erectile dysfunction buy cheap cialis discount online canadian health and care mall canada pharmacy online buy clomid without prescription uk canadian pharmacy without prescription rayhhealthcare online order medication canadian pharmacy no prescription best price 100mg viagra

    April 17, 2021 at 13:40 | Report abuse | Reply
  11. 토토사이트

    I seriously love your blog.. Very nice colors & theme. Did you build this web site yourself? Please reply back as Iím wanting to create my own personal blog and would like to know where you got this from or exactly what the theme is called. Cheers!


    April 17, 2021 at 14:41 | Report abuse | Reply
  12. erection pills viagra online

    erectile medication over counter https://canadaerectiledysfunctionpills.com/ erectile functioning

    April 17, 2021 at 15:36 | Report abuse | Reply
  13. ThomasBot

    no prescription pharmacy

    April 17, 2021 at 18:41 | Report abuse | Reply
  14. 토토사이트


    April 17, 2021 at 21:06 | Report abuse | Reply
  15. generic levitra vardenafil

    vardenafil cheap https://vegavardenafil.com/ generic vardenafil 20mg india

    April 17, 2021 at 21:22 | Report abuse | Reply
  16. order zithromax online

    zpack uti https://zithromaxes.com/ do i need a prescription for zithromax

    April 17, 2021 at 21:44 | Report abuse | Reply
  17. Carmella Quintanilla

    Wonderful blog! I found it while surfing around on Yahoo News.
    Do you have any tips on how to get listed in Yahoo News?
    I've been trying for a while but I never seem to get there!
    Appreciate it

    April 17, 2021 at 22:15 | Report abuse | Reply
  18. Magic Mushrooms Online

    You have actually covered this topic skillfully.


    April 18, 2021 at 00:52 | Report abuse | Reply
  19. Erwin Corley

    Hurrah! In the end I got a blog from where I be able to genuinely obtain valuable facts
    concerning my study and knowledge.

    April 18, 2021 at 00:55 | Report abuse | Reply
  20. 메이저사이트

    Itís nearly impossible to find educated people about this topic, but you seem like you know what youíre talking about! Thanks


    April 18, 2021 at 03:16 | Report abuse | Reply
  21. cập nhật kết quả bóng đá trực tiếp

    Go baseball team! trực tiếp vl1 Therefore, it is simply not a tricky task for someone to get your hands on these equipments.|Make sure ALL your players get the proper teaching. If you don't get the loading phase of a back corner arm correct, it's very difficult for your swing or throw to recover. There are thousands of online autographs sites.|Move the ball down the area 10 yards at an occasion. eat within the clock. Finally, no football bedroom would be complete without real footballs. At one end of the list will be most probable home is awarded.|The American odds are also called as money contours. In 1935 the Heisman Trophy, was manufactured to be awarded to one of the most outstanding football player. Late Olayinka John (Ayogi) was the then coach of eleven brothers.


    April 18, 2021 at 03:55 | Report abuse | Reply
  22. BrucePaumn

    cialis online no prescription cialis online no prescription

    April 18, 2021 at 05:42 | Report abuse | Reply
  23. Heathsap

    online pharmacy

    April 18, 2021 at 09:31 | Report abuse | Reply
  24. Richardbak

    canadian pharmacy cialis 20mg online pharmacy northwestern canada drugs suhagra supreme suppliers cialis samples without prescrpition canadian pharmacy viagra supreme suppliers mumbai 400 058 india paxil canada pharmacy no perscription North West Pharmacy what are the best generic ed drugs tretinoin cream uk

    April 18, 2021 at 09:45 | Report abuse | Reply
  25. JosephNam

    online drugstore canada

    April 18, 2021 at 11:01 | Report abuse | Reply
  26. BernardTig

    viagra jelly for sale uk supreme suppliers

    April 18, 2021 at 15:13 | Report abuse | Reply
  27. 먹튀검증

    Hi there! I just want to offer you a huge thumbs up for the excellent information you've got here on this post. I am returning to your website for more soon.


    April 18, 2021 at 22:54 | Report abuse | Reply
  28. BrucePaumn

    cialis without prescription cheap cialis no prescription

    April 18, 2021 at 23:24 | Report abuse | Reply
  29. nba live stream

    Express Your Passion For Soccer With Football Cufflinks ket qua bong ro Every sport has distinctive way of promoting its game. Football fans are known for wearing such things as scarves and hats as well as fans value more highly to make funny outfits too. The type that you with regard to needs to be able to light and soft so that you can do not get inflamed. There are well known brands which known for designing best in regards to sports attire. Rather opt for such brands vs . scarves which might be sold from street cranny.


    April 19, 2021 at 04:12 | Report abuse | Reply
  30. Delphia Como

    Today, while I was at work, my sister stole my iPad
    and tested to see if it can survive a thirty foot drop,
    just so she can be a youtube sensation. My apple ipad is now destroyed and she has 83 views.
    I know this is totally off topic but I had to share
    it with someone!

    April 19, 2021 at 04:50 | Report abuse | Reply
  31. 카지노사이트

    I like looking through an article that will make people think. Also, many thanks for allowing me to comment!


    April 19, 2021 at 05:13 | Report abuse | Reply
  32. steel line pipe specification

    . China Steel Line Pipe producers – Select 2021 high quality Steel Line Pipe products in finest price from certified Chinese Line Wire producers, Seamless Pipe suppliers, dealers and also factory


    April 19, 2021 at 09:48 | Report abuse | Reply
  33. 먹튀검증커뮤니티


    April 19, 2021 at 10:50 | Report abuse | Reply
  34. BernardTig

    best place to get viagra supreme suppliers viagra

    April 19, 2021 at 12:28 | Report abuse | Reply
  35. Heathsap

    sky pharmacy online

    April 19, 2021 at 13:47 | Report abuse | Reply
  36. 카지노사이트


    April 19, 2021 at 13:57 | Report abuse | Reply
  37. JosephNam

    canadian pharmacy store

    April 19, 2021 at 14:40 | Report abuse | Reply
  38. BrucePaumn

    generic cialis without prescription cialis without a doctors prescription

    April 19, 2021 at 16:28 | Report abuse | Reply
  39. Delmar Borders

    It's awesome in support of me to have a web site, which is useful in support of my knowledge.

    thanks admin

    April 19, 2021 at 16:39 | Report abuse | Reply
  40. xem trực bóng đá hôm nay

    There are several other traditions that always accompany the Navy football team xem bd truc tuyen For example, the "E" Bell rings whenever Navy beats Army in any of the three seasons of sports. This bell is from the bridge of USS Enterprise, a famed World War II aircraft carrier. Experts have a tradition since 1950. The Gokokuji Bell is really a replica within a bell that's brought to the United States by Commodore Matthew Perry in 1854. The original bell, which was donated into the Academy by his widow, was retur ned to Okinawa in 1988. This bell is also rung each time the team scores a football victory over their Army opponents. This bell sits in front of Bancroft Hall in Annapolis.


    April 19, 2021 at 19:07 | Report abuse | Reply
  41. ollis bator

    My Name Ollis Bator from Tx,USA. After 12years of marriage, me and my husband have been into one quarrel or the other until he finally left me and moved to California to be with another woman. I felt my life was over and my kids thought they would never see their father again. I tried to be strong just for the kids but I could not control the pains that tormented my heart, my heart was filled with sorrows and pains because I was really in love with my husband. Every day and night I think of him and always wish he would come back to me, I was really upset and I needed help, so I searched for help online and I came across a website that suggested that Dr. Wale can help get ex back fast. So, I felt I should give him a try. I contacted him and he told me what to do and I did it then he did a Love spell for me. 24 hours later, my husband really called me and told me that he missed me and the kids so much, So Amazing!! So that was how he came back that same day, with lots of love and joy, and he apologized for his mistake, and for the pain he caused me and the kids. Then from that day, our Marriage was now stronger than how it was before, All thanks to Dr. Wale. he is so powerful and I decided to share my story on the internet with Dr. Wale real and powerful spell caster who I will always pray to live long to help his children in the time of trouble, if you are here and you need your ex back or your husband moved to another woman, do not cry anymore, contact this powerful spell caster now. Here’s is his WhatsApp number +1(978) 406-9575 https://wa.me/message/D5K3QBMTWZ3BA1 or Email everlastingspellcast@gmail.com or view his website for more review everlastingspellcaster.website2.me/contact

    April 20, 2021 at 00:20 | Report abuse | Reply
  42. Heathsap

    sky pharmacy online drugstore review

    April 20, 2021 at 03:47 | Report abuse | Reply
  43. JosephNam

    canadian overnight pharmacy

    April 20, 2021 at 04:25 | Report abuse | Reply
  44. 카지노사이트

    Your style is unique compared to other folks I have read stuff from. I appreciate you for posting when you've got the opportunity, Guess I will just bookmark this web site.


    April 20, 2021 at 06:45 | Report abuse | Reply
  45. BernardTig

    generic viagra from usa supreme suppliers mumbai 400 058 india

    April 20, 2021 at 09:32 | Report abuse | Reply
  46. 먹튀검증사이트


    April 20, 2021 at 09:48 | Report abuse | Reply
  47. BrucePaumn

    cialis without a doctor's prescription cialis sales no prescription drugs

    April 20, 2021 at 10:14 | Report abuse | Reply
  48. 먹튀


    April 20, 2021 at 14:31 | Report abuse | Reply
  49. 먹튀사이트

    I need to to thank you for this very good read!! I certainly enjoyed every bit of it. I have you bookmarked to check out new things you postÖ


    April 20, 2021 at 15:03 | Report abuse | Reply
  50. Heathsap

    canadian pharm support group

    April 20, 2021 at 18:09 | Report abuse | Reply
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43

Leave a Reply to bài


CNN welcomes a lively and courteous discussion as long as you follow the Rules of Conduct set forth in our Terms of Service. Comments are not pre-screened before they post. You agree that anything you post may be used, along with your name and profile picture, in accordance with our Privacy Policy and the license you have granted pursuant to our Terms of Service.

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.