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

Novartis Japan admits concealing drug side effects

12 hours ago

The Japanese unit of Swiss pharma giant Novartis has admitted it did not report more than 2,500 cases of serious side effects in patients using its leukaemia and other cancer drugs, reportedly including some fatalities.

Most US babies get their vaccines, CDC says

Aug 28, 2014

(HealthDay)—The vast majority of American babies are getting the vaccines they need to protect them from serious illnesses, federal health officials said Thursday.

Expression of privilege in vaccine refusal

Aug 27, 2014

Not all students returning to school this month will be up to date on their vaccinations. A new study conducted by Jennifer Reich, a researcher at the University of Colorado Denver, shows that the reasons why children may ...

User comments