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 (129 Responses)
  1. 실제 돈 카지노

    Best view i have ever seen !

    https://bestplay777.com

    January 1, 2021 at 16:31 | Report abuse | Reply
  2. Tamra Weiss

    If you would like to improve your experience simply keep visiting this site and be updated with the most up-to-date gossip posted here.

    http://bit.ly/3hFz4mB

    January 3, 2021 at 22:29 | Report abuse | Reply
  3. vreyrolinomit

    Fantastic website. Plenty of helpful info here. I am sending it to some buddies ans also sharing in delicious. And of course, thank you on your sweat!

    http://www.vreyrolinomit.com/

    January 4, 2021 at 09:44 | Report abuse | Reply
  4. Garnet

    Link exchange is nothing else but it is just placing the other person's
    blog link on your page at proper place and other
    person will also do similar for you.

    Feel free to surf to my website; Kathaleen

    January 5, 2021 at 04:08 | Report abuse | Reply
  5. 바카라 전략

    Best view i have ever seen !

    https://yesbet88baccarat.com

    January 5, 2021 at 06:43 | Report abuse | Reply
  6. Ileana Mullis

    Thanks so much the information. I love sucking dick btw hmu

    https://chrok1.blogspot.com/2021/01/5.html

    January 5, 2021 at 16:44 | Report abuse | Reply
  7. how to become a cbd distributor in va

    Good Afternoon everybody , can anyone suggest where I can purchase CBD Gummy Slices Pm 25mg 50mg By Proleve?

    https://justcbdstore.uk/product-category/cbd-isolate/

    January 7, 2021 at 03:35 | Report abuse | Reply
  8. roulette

    Best view i have ever seen !

    https://toproulette.live

    January 7, 2021 at 14:08 | Report abuse | Reply
  9. Carly Mae

    Thanks so much the information. I love sucking dick btw hmu

    https://chrok1.blogspot.com

    January 7, 2021 at 21:04 | Report abuse | Reply
  10. vreyro linomit

    Thank you for the sensible critique. Me & my neighbor were just preparing to do a little research about this. We got a grab a book from our local library but I think I learned more clear from this post. I am very glad to see such fantastic information being shared freely out there.

    http://www.vreyrolinomit.com/

    January 8, 2021 at 10:54 | Report abuse | Reply
  11. Nicky Serb

    https://www.electricpercolatorcoffeepot.com/10-top-coffee-bloggers/

    January 11, 2021 at 00:32 | Report abuse | Reply
  12. Marcella Bonaccorso

    Can I publish your publish to my blog? I’ll add a one-way link to your forum. That’s one actually candy post.

    http://yourmatrixcashmachine.com

    January 12, 2021 at 00:51 | Report abuse | Reply
  13. Gracelynn

    are vapes dangerous 2019

    https://dailyuploads.net/p67nds9urpt2

    January 13, 2021 at 01:27 | Report abuse | Reply
  14. Fairy Dalzen

    Strongly disagree

    https://miginia.com

    January 13, 2021 at 01:45 | Report abuse | Reply
  15. Rose Mile

    Getting your lover or your ex back has been made more easy by this powerful spell caster called Dr Odion. I am Rose by name and i am from canada, the only reason why i am on this site is to thank this powerful spell caster called DR. Odion and you can improve your relationship success by contacting him through these details (wisdomspiritualtemple@gmail.com Or call +2348136482342) This powerful spell caster did me a huge favor by helping me get my lover back to me within the speed of light and since then my relationship has been perfect.

    any problem of yours.He is specialized in the following:

    (1)Spell for protection from danger
    (2)Spell for magic
    (3)Spell for same sex love
    (4)Spell for healing
    (5)Spell for invisibility
    (6)Spell for riches and fame
    (7)Spell to get a good job
    (8)Spell for strong love and relationship
    (9)Spell to bring your ex back
    (10)speII for Lottery
    This man has great powers and is incredibly generous.You can contact him on
    (wisdomspiritualtemple@gmail.com)

    January 15, 2021 at 11:43 | Report abuse | Reply
1 2 3

Leave a Reply to Asics Gel Lyte III Champagne Pack Plata Baratas


 

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.