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

FDA to start regulating lab-developed tests

Jul 31, 2014

(AP)—The Food and Drug Administration announced Thursday it will begin regulating laboratory-developed tests, a growing class of medical diagnostics that have never before been subject to federal oversight.

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

User comments