home
RSS
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 (2,118 Responses)
  1. Alyssa Stolarski

    This was awesome! I would like you to clean up all this spam though

    https://www.linkedin.com/in/yusuf-hanafy-82493b183

    May 12, 2021 at 05:16 | Report abuse | Reply
  2. Dennismor

    sky pharmacy

    May 12, 2021 at 06:37 | Report abuse | Reply
  3. Douglasovefs

    nizagara

    May 12, 2021 at 09:25 | Report abuse | Reply
  4. ThomasBot

    pharmacy online

    May 12, 2021 at 09:57 | Report abuse | Reply
  5. Richardbak

    supreme suppliers canadian pharmacies that accept paypal canadian pharmacy online no script supreme suppliers cialis samples overnight northwestern canada drugs order cipro online supreme suppliers canadian pharmacy online no script Reputable Canadian Mail Order Pharmacies generic impotence pills order retin a

    May 12, 2021 at 10:17 | Report abuse | Reply
  6. ArnoldoLoP

    healthy man viagra offer

    May 12, 2021 at 20:10 | Report abuse | Reply
  7. Douglasovefs

    nizagara cheapest

    May 12, 2021 at 22:09 | Report abuse | Reply
  8. ThomasBot

    sky pharmacy online drugstore

    May 12, 2021 at 23:12 | Report abuse | Reply
  9. Richardbak

    canadian pharmacy no prescription canadian pharmacy no prescription canadianpharmacy supreme suppliersmumbaiindia cialis sample pack 24 hour canadian pharmacy supremesuppliers canadian pharmacy mall Canadian Pharmacies That Are Legit best drugs for ed retin a buy online

    May 12, 2021 at 23:32 | Report abuse | Reply
  10. Douglasovefs

    buy nizagara online

    May 13, 2021 at 10:53 | Report abuse | Reply
  11. ThomasBot

    pacific care pharmacy

    May 13, 2021 at 12:28 | Report abuse | Reply
  12. Richardbak

    supreme suppliers canadianpharcharmyonline.com online pharmacy supreme suppliers in india viagra samples cialis canadian pharmacy online cialis supreme suppliers viagra canadian pharmacy mall Canadian Health Care Cost ed pill best place to buy tretinoin 0.05

    May 13, 2021 at 12:54 | Report abuse | Reply
  13. RaymondElupt

    onlinepharmacy

    May 13, 2021 at 16:54 | Report abuse | Reply
  14. 사설토토

    After looking into a number of the blog posts on your website, I seriously like your technique of blogging. I book marked it to my bookmark webpage list and will be checking back in the near future. Take a look at my website too and tell me how you feel.

    https://www.gatesofantares.com/players/gambling3cactusclover1/activity/630039/

    May 13, 2021 at 18:10 | Report abuse | Reply
  15. Sherryl Edye

    I always spent my half an hour to read this blog's articles or reviews every day
    along with a mug of coffee.

    May 13, 2021 at 21:49 | Report abuse | Reply
  16. Dennismor

    pharmacyrxone

    May 13, 2021 at 22:37 | Report abuse | Reply
  17. 토토사이트

    The very next time I read a blog, I hope that it does not fail me just as much as this particular one. After all, Yes, it was my choice to read, nonetheless I actually believed you would probably have something interesting to say. All I hear is a bunch of crying about something you could possibly fix if you were not too busy looking for attention.

    https://squareblogs.net/baccarat4swisscloth1/online-slots-and-payouts-everything-you-need-to-know

    May 14, 2021 at 01:24 | Report abuse | Reply
  18. ThomasBot

    pharmacy on line

    May 14, 2021 at 02:21 | Report abuse | Reply
  19. JosephNam

    canadian pharmacy no prescription

    May 14, 2021 at 02:59 | Report abuse | Reply
  20. Bobbyoffek

    Online Pharmacy no prescription discount pharmacy

    May 14, 2021 at 04:42 | Report abuse | Reply
  21. best dry herb vaporizer under 100 2018

    However, be sure to choose a web page that is reputable. Cat condo I pick Bama as your best in recent history. Plus, it really helps build focus and strength of mind humidifier or vaporizer{The buzzing activities in the football fan gift shops go as many as a new high the actual football world cup. Examine the comfort quotient of t-shirts while choosing one their own store. This really is where most go horribly wrong.|The other, shoot for almost any box that's 80 of the best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 05:29 | Report abuse | Reply
  22. PrestonAbede

    sildenafil generic viagra supreme suppliers viagra generic viagra shipped from usa

    May 14, 2021 at 06:10 | Report abuse | Reply
  23. Jamesraire

    canadian pharmacy no prescription

    May 14, 2021 at 06:11 | Report abuse | Reply
  24. ArnoldoLoP

    healthy man viagra scam

    May 14, 2021 at 06:23 | Report abuse | Reply
  25. DavidAdess

    rhine inc india complaints

    May 14, 2021 at 07:27 | Report abuse | Reply
  26. Brianwit

    cialis online without prescription

    May 14, 2021 at 10:35 | Report abuse | Reply
  27. somerville smoke shop

    However, be certain choose an online site that is trustworthy. Precisely why I pick Bama as your best often. Plus, it really helps build focus and strength of mind crazy dab rig{The buzzing activities in the football fan gift shops go up to a new high through the football world cup. Look at the comfort quotient of t-shirts while choosing one all of them. Motivating where most go horribly wrong.|The other, shoot for that box because of this 80 of the best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 11:00 | Report abuse | Reply
  28. dab pen vs rig

    However, be likely to choose a web site that is honest. On the internet . I pick Bama when compared to the best ever sold. Plus, it really helps build focus and strength of mind one hitter for weed{The buzzing activities in the football fan gift shops go approximately a new high throughout the football world cup. Examine the comfort quotient of t-shirts while choosing one all of them. Motivating where most go horribly wrong.|The other, shoot to your box which isn't 80 of your best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 11:38 | Report abuse | Reply
  29. smoke shop miami

    However, be going to choose an online site that is honest. On the internet . I pick Bama beeing the best out of them all. Plus, it really helps build focus and strength of mind smoke shop myrtle beach{The buzzing activities in the football fan gift shops go as many as a new high during the football world cup. Check the comfort quotient of t-shirts while choosing one from them. Motivating where most go horribly wrong.|The other, shoot for a box naturally 80 of the best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 12:54 | Report abuse | Reply
  30. one hitter box

    However, be going to choose a web page that is trustworthy. That's why I pick Bama when compared to the best often. Plus, it really helps build focus and strength of mind mini bong cheap{The buzzing activities in the football fan gift shops go equal to a new high your football world cup. Check the comfort quotient of t-shirts while choosing one from them. Is offering where most go horribly wrong.|The other, shoot to find a box that's 80 of your best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 13:11 | Report abuse | Reply
  31. ez smoke shop

    However, be going to choose a web site that is reputable. On the internet . I pick Bama beeing the best possibly. Plus, it really helps build focus and mental toughness best portable vaporizer 2020{The buzzing activities in the football fan gift shops go at least a new high throughout the football world cup. Look at the comfort quotient of t-shirts while choosing one from. This particular really is where most go horribly wrong.|The other, shoot to find a box which isn't 80 of your best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 13:29 | Report abuse | Reply
  32. 먹튀검증

    This site was... how do you say it? Relevant!! Finally I have found something that helped me. Thanks!

    https://files.fm/f/8yuy88xy2

    May 14, 2021 at 13:32 | Report abuse | Reply
  33. water line pipes

    However, be apt to choose a web site that is honest. That's why I pick Bama for the best ever possible. Plus, it really helps build focus and strength of mind best one hitter pipe{The buzzing activities in the football fan gift shops go equal to a new high through the football world cup. Look at the comfort quotient of t-shirts while choosing one their own store. Will be where most go horribly wrong.|The other, shoot for just about any box which isn't 80 of your best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 13:45 | Report abuse | Reply
  34. Dennismor

    canadian pharmacy no presc

    May 14, 2021 at 13:50 | Report abuse | Reply
  35. e cigarettes vs vaporizer

    However, be apt to choose a webpage that is reputable. Cat condo I pick Bama when compared to the best ever. Plus, it really helps build focus and strength of mind vaporizer whip replacement{The buzzing activities in the football fan gift shops go approximately a new high during the football world cup. Look at the comfort quotient of t-shirts while choosing one all of them. Will be where most go horribly wrong.|The other, shoot for a box which isn't 80 of your best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 14:29 | Report abuse | Reply
  36. thick ass glass bong

    However, be sure to choose an online site that is reputable. On the internet . I pick Bama as your best in recent history. Plus, it really helps build focus and mental toughness head shop pipes{The buzzing activities in the football fan gift shops go to as much as a new high your football world cup. Examine the comfort quotient of t-shirts while choosing one all of them. It is vital where most go horribly wrong.|The other, shoot for a box which 80 of the best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 14:30 | Report abuse | Reply
  37. best 3 in 1 vaporizer

    However, be likely to choose your site that is trustworthy. Exactly why I pick Bama mainly because best in recent history. Plus, it really helps build focus and mental toughness g pen elite vaporizer review{The buzzing activities in the football fan gift shops go up to a new high the actual football world cup. Examine the comfort quotient of t-shirts while choosing one all of them. This really is where most go horribly wrong.|The other, shoot to find a box naturally 80 of the best box height.

    https://pilotdiarystore.com/

    May 14, 2021 at 14:50 | Report abuse | Reply
  38. 토토

    I blog often and I really thank you for your content. Your article has truly peaked my interest. I'm going to bookmark your site and keep checking for new information about once per week. I opted in for your Feed as well.

    https://orlandotechnologygroup.com/members/baccarat1memorystraw8/activity/116592/

    May 14, 2021 at 16:40 | Report abuse | Reply
  39. ThomasBot

    online pharmacy no prescription

    May 14, 2021 at 17:32 | Report abuse | Reply
  40. Bobbyoffek

    Online pharmacies canadian pharmacies

    May 14, 2021 at 17:56 | Report abuse | Reply
  41. EdwardSwogy

    http://www.skypharmacyreview.com trusted Pharmacy

    May 14, 2021 at 19:56 | Report abuse | Reply
  42. Jamesraire

    canadian online pharmacy

    May 14, 2021 at 21:32 | Report abuse | Reply
  43. PrestonAbede

    find trusted website to buy viagra supreme suppliers mumbai 400 058 india viagra pas cher au canada

    May 14, 2021 at 23:23 | Report abuse | Reply
  44. DavidAdess

    rhine inc india cialis

    May 15, 2021 at 00:33 | Report abuse | Reply
  45. dry herb vaporizer weed

    However, be certain choose a website that is reputable. On the internet . I pick Bama as compared to the best out of them all. Plus, it really helps build focus and mental toughness small rolling tray{The buzzing activities in the football fan gift shops go to as much as a new high during the football world cup. Look at the comfort quotient of t-shirts while choosing one from. This particular really is where most go horribly wrong.|The other, shoot for almost any box that's 80 of the best box height.

    https://pilotdiarystore.com/

    May 15, 2021 at 01:20 | Report abuse | Reply
  46. how to make a homeade vaporizer

    However, be apt to choose an affiliate site that is trustworthy. On the internet . I pick Bama beeing the best in recent history. Plus, it really helps build focus and strength of mind purple glass bowl{The buzzing activities in the football fan gift shops go equal to a new high through the football world cup. Look at the comfort quotient of t-shirts while choosing one their own store. Motivating where most go horribly wrong.|The other, shoot to find a box which usually is 80 of one's best box height.

    https://pilotdiarystore.com/

    May 15, 2021 at 01:21 | Report abuse | Reply
  47. Dennismor

    blue mountain pharmacy canada

    May 15, 2021 at 05:09 | Report abuse | Reply
  48. glass bong bowl

    However, be apt to choose a web site that is reputable. The reason why I pick Bama beeing the best ever sold. Plus, it really helps build focus and mental toughness wax pen attachment{The buzzing activities in the football fan gift shops go approximately a new high the actual football world cup. Examine the comfort quotient of t-shirts while choosing one from. This really is where most go horribly wrong.|The other, shoot for a box that's 80 of the best box height.

    https://pilotdiarystore.com/

    May 15, 2021 at 06:28 | Report abuse | Reply
  49. Bobbyoffek

    Online Pharmacy canadian pharmacy

    May 15, 2021 at 06:57 | Report abuse | Reply
  50. Brianwit

    cialis without a doctor's prescription

    May 15, 2021 at 07:10 | 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 DavidAdess


 

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.

Advertisement
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.