Skip to content
Catholic Online Logo

By Catholic Online (NEWS CONSORTIUM)

8/12/2014 (2 months ago)

Catholic Online (www.catholic.org)

Cologuard test outweighed its risks, FDA says

Screening for colon cancer is frequently arduous and invasive. Patients need to fast prior to a colonoscopy, and the colonoscopy itself be highly uncomfortable and not always accurate. There's now good news for those at risk. The U.S. Food and Drug Administration has approved a new at-home, DNA-based stool test that screens for colorectal cancer with more than 90 percent accuracy.

The U.S. Food and Drug Administration has approved a new at-home, DNA-based stool test that screens for colorectal cancer with more than 90 percent accuracy.

The U.S. Food and Drug Administration has approved a new at-home, DNA-based stool test that screens for colorectal cancer with more than 90 percent accuracy.

Highlights

By Catholic Online (NEWS CONSORTIUM)

Catholic Online (www.catholic.org)

8/12/2014 (2 months ago)

Published in Health

Keywords: Colon cancer, in-home test, blood in feces, Cologuard


LOS ANGELES, CA (Catholic online) - "This approval offers patients and physicians another option to screen for colorectal cancer," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health says.

The board's decision was based on an FDA panel's unanimous decision last March. At that time, it was determined that the benefits of Exact Sciences Corp.'s Cologuard test outweighed its risks.

SAVE Iraqi Christians from Genocide --


"Fecal blood testing is a well-established screening tool and the clinical data showed that the test detected more cancers than a commonly used fecal occult [blood] test," Gutierrez said.

The U.S. Centers for Medicare & Medicaid Services simultaneously announced that it would review the potential for nationwide coverage of the Cologuard test. The agency has gone as far to propose that the stool test be covered for people aged 50 to 85 who have no symptoms of colorectal disease and who are at average risk for colon cancer.

"This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day," Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS, said in the news release.

Nearly 143,000 new cases of colorectal cancer were diagnosed in the United States last year. Almost 50,000 Americans died of the disease, according to the U.S. National Cancer Institute.

A study published in March in the New England Journal of Medicine found Cologuard had a very high accuracy rate in spotting colon cancer.

Experts agree that an accurate, noninvasive test would be a huge addition to the fight against colon cancer. One-third of Americans fail to heed public health recommendations to undergo invasive colonoscopy every 10 years starting at age 50.

Commonly used stool tests such as FIT (fecal immunochemical testing) rely on detecting blood in the stool. The new Cologuard test checks for blood as well as abnormal DNA, "with the advantage that some lesions, even cancers, don't bleed very much," Dr. Steven Itzkowitz, director of the gastroenterology fellowship program at the Icahn School of Medicine at Mount Sinai says.

The Cologuard test also features a DNA analysis not included in other fecal exams.

"By increasing the pick-up rate in this way, we found that the new test had a 92 percent sensitivity for detection of colorectal cancer. That kind of result is really unprecedented for a noninvasive stool-based screening."

---


Pope Francis: end world hunger through 'Prayer and Action'


2014 - Distributed by THE NEWS CONSORTIUM

Pope Francis Prayer Intentions for October 2014
Peace:
That the Lord may grant peace to those parts of the world most battered by war and violence.
World Mission Day: That World Mission Day may rekindle in every believer zeal for carrying the Gospel into all the world.



Comments


More Health

Quarantined Ebola-positive doctor used subway, went to bowling alleys Watch

Image of Dr. Craig Spencer, an American doctor living in New York City, is under quarantine after testing positive for the Ebola virus.

By Catholic Online (NEWS CONSORTIUM)

As Dr. Craig Spencer, an American doctor living in New York City, is under quarantine after testing positive for the Ebola virus, officials are frantically tracking his steps throughout the city in order to see who could have been exposed. LOS ANGELES, CA ... continue reading


While death rates fall, tuberculosis still leaves millions stricken Watch

Image of The WHO said that insufficient funding was hampering efforts to combat the disease. An estimated $8 billion was needed each year.

By Catholic Online (NEWS CONSORTIUM)

For a completely curable disease, tuberculosis continues its deadly worldwide toll. The World Health Organization says that about 1.5 million people died in 2013 from TB, including 360,000 people who were HIV positive. The organization estimates that there are ... continue reading


Have we passed the tipping point? Drug resistant tuberculosis could kill millions Watch

Image of Tuberculosis, also known as the

By Catholic Online (NEWS CONSORTIUM)

The World Health Organization (WHO) has reported that multidrug resistant tuberculosis (TB) is reaching a tipping point, with about 480,000 new cases having occurred this year. LOS ANGELES, CA (Catholic Online) - The lung disease killed nearly 1.5 million people ... continue reading


What's the biggest danger in your home? It will shock and disgust you Watch

Image of Kitchen towels in your home may be the biggest danger to the health of you and your family.

By Catholic Online (NEWS CONSORTIUM)

The biggest danger in your house aren't stairs, bugs or chemicals, but actually may be hand towels kept in the kitchen. LOS ANGELES, CA (Catholic Online) - Kitchen towels may spread food poisoning, bacteria or other dangerous microorganisms around your home without any ... continue reading


NOT long enough: Ebola could lay dormant in the body for longer than 21 days, expert claims Watch

Image of Biology Professor Charles Hass, who has vast experience of analyzing the risk of transmitting biological pathogens, said

By Catholic Online (NEWS CONSORTIUM)

A new study warns that the recommended 21-day quarantine period for the Ebola virus is not long enough to contain the spread of the disease. While the World Health Organization advises the incubation period for the virus is between two and 21 days, scientists ... continue reading


Nurse says Texas Presbyterian Hospital was chaotic and filthy during Ebola outbreak Watch

Image of

By Catholic Online (NEWS CONSORTIUM)

Texas Presbyterian Hospital in Dallas, Texas, reacted very poorly when it discovered that they had been treating a Liberian man with Ebola. According to a nurse who has since come forward, safety regulations were blithely ignored, contaminated linens and waste ... continue reading


Why aren't we doing this? Colombia bans entry to those from Ebola affected countries Watch

Image of A Liberian man is having his temperature taken by a no-contact thermometer.

By Catholic Online (NEWS CONSORTIUM)

Two countries have started barring entry to people coming from the nations in West Africa that have been hardest hit by the current Ebola outbreak. LOS ANGELES, CA (Catholic Online) - Kenny Anthony, the prime minister of St. Lucia-a small island nation in the ... continue reading


Second Dallas health worker contracts Ebola virus Watch

Image of Workers scrub down Amber Vinson's apartment in Dallas, Texas.

By Catholic Online (NEWS CONSORTIUM)

A second Dallas health care worker has since contracted the Ebola virus - and authorities are now frantically trying to contact the more than 100 plus passengers with whom she shared a flight. Authorities says that the employee, Amber Vinson reportedly showed ... continue reading


World has until Christmas to control Ebola; all bets off afterwards Watch

Image of The World Health Organization, or WHO earlier said there could be 10,000 new cases of Ebola per week within two months.

By Catholic Online (NEWS CONSORTIUM)

The United Nations says the Ebola outbreak must be controlled within 60 days. Otherwise, the world faces an "unprecedented" situation for which there is no plan. Ebola, according to the U.N. "is running faster than us and it is winning the race." LOS ANGELES, ... continue reading


The horrifying truth of Ebola: WHO suggests 10,000 could become infected per week Watch

Image of An aid worker carries a child infected with Ebola in Liberia, one of the West African nations hardest hit by the outbreak.

By Catholic Online (NEWS CONSORTIUM)

The World Health Organization (WHO) has issued a dire warning to the world. On October 14 they announced that the death rate of the current Ebola outbreak in West Africa is now 70%, much higher than usual. Even more horrifying, the WHO has stated that West Africa ... continue reading


All Health News

Newsletters

Newsletter Sign Up icon

Stay up to date with the latest news, information, and special offers

Daily Readings

Reading 1, Ephesians 4:7-16
7 On each one of us God's favour has been bestowed in ... Read More

Psalm, Psalms 122:1-2, 3-4, 4-5
1 [Song of Ascents Of David] I rejoiced that they ... Read More

Gospel, Luke 13:1-9
1 It was just about this time that some people ... Read More

Saint of the Day

Saint of the Day for October 25th, 2014 Image

St. Daria
October 25: There is very little known about them. Chrysanthus was an ... Read More

Inform, Inspire & Ignite Logo

Find Catholic Online on Facebook and get updates right in your live feed.

Become a fan of Catholic Online on Facebook


Follow Catholic Online on Twitter and get News and Product updates.

Follow us on Twitter