FDA panel narrowly backs DNA colon cancer test

A panel of Food and Drug Administration advisers has narrowly backed an experimental blood test that uses patients' DNA to help screen for colon cancer.

The FDA's genetic experts voted 5-4, with one abstention, that the benefits of Epigenomics' test outweigh the risks. The vote amounts to a recommendation for approval of the company's Epi proColon kit. The FDA is not required to follow the panel's recommendation.

Doctors have long used stool tests to look for hidden blood that can be an of cancer. Epigenomics' test is part of a new wave of diagnostics that detect genetic markers associated with .

FDA scientists said in their review earlier this week that Epi proColon did not meet all of its accuracy goals in testing against older, stool-based technology.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA reviews DNA-based colon cancer screening kits

Mar 24, 2014

The Food and Drug Administration is weighing the benefits and risks of two experimental colon cancer screening tests which use DNA from a patient's stool to detect dangerous tumors and growths.

FDA panel again rejects wider use of J&J's Xarelto

Jan 16, 2014

A panel of Food and Drug Administration experts again opposed expanding use of Johnson & Johnson's blood thinner Xarelto to reduce dangerous blood clots in a new group of patients, those with acute coronary artery disease.

Experimental diabetes drug makes comeback

Dec 12, 2013

A panel of federal health advisers has backed the benefits of an experimental diabetes drug that uses a new method to reduce blood sugar, setting aside previous concerns about the pill's safety.

FDA panel backs Pfizer drug for kidney cancer

Dec 07, 2011

(AP) -- A panel of advisers to the Food and Drug Administration voted Wednesday that the benefits of a Pfizer kidney cancer drug outweigh its risks, according to a company spokeswoman.

FDA advisers unanimously back J&J hepatitis C drug

Oct 24, 2013

An experimental hepatitis C drug from Johnson & Johnson has won unanimous support from government experts who say the medication should be approved to treat patients infected with the liver-destroying virus.

Recommended for you

Vaccine proves effective against deadly Middle East virus

17 hours ago

(Medical Xpress)—A vaccine developed by an international team of scientists led by the University of Pittsburgh School of Medicine successfully protects mice against a contagious and deadly virus spreading across the Middle ...

New study looks at improving vaccine awareness

18 hours ago

The best medical therapies won't do much good if the public abstains from using them. Resistance to life-saving interventions may have a variety of root causes, particularly if the biotechnology involved is new and poorly ...

High-dose opioid prescribing continues to climb

Sep 12, 2014

High-dose opioid prescribing increased by 23 per cent in Canada between 2006 and 2011, despite clinical guidelines recommending that most patients should avoid high-doses of these drugs, according to new ...

Feds say Bayer colon supplement makes bogus claims

Sep 12, 2014

The United States government accused Bayer of making scientifically unproven statements about the health benefits of a popular probiotic on Friday, claiming the German pharmaceutical giant was in contempt of court.

User comments