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 (189 Responses)
  1. vreyro linomit

    Hello, you used to write magnificent, but the last few posts have been kinda boring?K I miss your tremendous writings. Past several posts are just a little bit out of track! come on!


    February 16, 2021 at 00:14 | Report abuse | Reply
  2. n95 mask

    This is great! I'm happy I found your post because it's an improvement on similar posts I've seen from most other bloggers about this subject. Can I ask you to clarify some things? Maybe show any further example? Thank you!


    February 18, 2021 at 07:47 | Report abuse | Reply
  3. https://www.yamatocosmos.com

    Best view i have ever seen !


    February 18, 2021 at 14:03 | Report abuse | Reply
  4. Will Brown

    I was suffering from herpes since January before I met Dr Ajayi who got me cured. Thank god.‼️    I'm cured. I had for some time now noticed having difficulty in pain. Never in my wildest dreams did it cross my mind that I may develop a serious herpes disease. Few months ago I purchased  herbal remedy from Dr Ajayi, after taking it for 14 days, I was totally reversed. I'm so happy to share this great news to everyone and I want to advise anyone suffering from herpes diseases or any type of diseases he will get you cured. you may need his email for assistance. Email him at ajayiherbalhome@gmail.com  you can also call or whatsapp him +2348154724883. visit his website https://ajayiherbalhome.weebly.com for more information      

    February 19, 2021 at 22:21 | Report abuse | Reply
  5. froleprotrem

    Wonderful work! This is the kind of information that are meant to be shared around the internet. Disgrace on the seek engines for no longer positioning this post upper! Come on over and visit my site . Thanks =)


    February 20, 2021 at 01:21 | Report abuse | Reply
  6. Buy Proxy Ip Address

    There's noticeably a bundle to find out about this. I assume you made sure good factors in options also.


    February 20, 2021 at 02:05 | Report abuse | Reply
  7. remote pc assistance

    Enjoyed examining this, very good stuff, thankyou. "The fox knows many things, but the hedgehog knows one big thing." by Archilocus.


    February 21, 2021 at 05:45 | Report abuse | Reply
  8. best face masks

    You neglected something..


    February 22, 2021 at 06:11 | Report abuse | Reply
  9. Mitch Formento

    Excellent article. I certainly appreciate this site. Keep it up!


    February 22, 2021 at 10:00 | Report abuse | Reply
  10. british blue cat

    Your place is valueble for me. Thanks!…https://britishshorthair.company.com/


    February 22, 2021 at 18:21 | Report abuse | Reply
  11. bengal cats

    I had been very pleased to locate this internet site https://bengals.company.com


    February 22, 2021 at 19:07 | Report abuse | Reply
  12. samoyed price

    Hi, Neat post. https://samoyedpups.company.com


    February 22, 2021 at 19:45 | Report abuse | Reply
  13. exotic shorthair breeders

    Right here is the perfect site for everyone who really wants to understand this topic. https://inxscinema.com/


    February 22, 2021 at 20:24 | Report abuse | Reply
  14. ball python for sale

    Right here is the perfect site for everyone who really wants to understand this topic. https://nosesso.net/


    February 22, 2021 at 21:15 | Report abuse | Reply
  15. macaw parrot

    I was able to find good information from your articles. https://volunteering-ni.org/


    February 22, 2021 at 22:18 | Report abuse | Reply
  16. exotic shorthair

    This article offers clear idea designed for the new people blogging http://fanceat.com/


    February 22, 2021 at 22:38 | Report abuse | Reply
  17. penis envy mushroom

    Hello. splendid job. I did not imagine this. This is a splendid story. https://majicpsychedelics.com/


    February 22, 2021 at 22:57 | Report abuse | Reply
  18. ilg6hws1o

    627856 545504Aw, this was a actually good post. In thought I would like to put in writing like this in addition – taking time and actual effort to make a really excellent article but what can I say I procrastinate alot and by no indicates appear to get something done. 966896

    February 23, 2021 at 09:51 | Report abuse | Reply
  19. Inbound Call Center Philippines

    Great post.. Especially, for those of us who have ever worked in a call center doing inbound sales calls!


    February 23, 2021 at 13:15 | Report abuse | Reply
  20. successful affiliate marketing websites

    I have been reading out many of your stories and i can claim pretty nice stuff. I will definitely bookmark your website.


    February 23, 2021 at 15:23 | Report abuse | Reply
  21. 메리트카지노쿠폰

    You are so awesome! I do not suppose I've truly read a single thing like this before. So nice to discover somebody with some original thoughts on this issue. Really.. thanks for starting this up. This site is something that's needed on the web, someone with a little originality!


    February 24, 2021 at 02:44 | Report abuse | Reply
  22. 메리트카지노


    February 24, 2021 at 08:44 | Report abuse | Reply
  23. API 5CT drill pipe size

    Maintain the incredible work !! Lovin' it!


    February 25, 2021 at 10:17 | Report abuse | Reply
  24. Steel pile pipe Distributors

    I love looking at your websites. Cheers!


    February 26, 2021 at 05:04 | Report abuse | Reply
  25. você pode verificar aqui

    Ai no campo site deixei uma página para você analisar. Todos que trabalham com marketing digital precisam descobrir isso.


    February 26, 2021 at 10:02 | Report abuse | Reply
1 2 3 4

Leave a Reply to Mzansi


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.