An FDA panel recommends approval of a blood test for colon cancer

A panel at the Food and Drug Administration (FDA) suggested on Thursday that a novel blood test that can identify colorectal and colon cancer be approved.

According to the World Health Organization, colon cancer is the second largest cause of cancer deaths in the US and worldwide and most common in older persons. Third most frequent cancer worldwide is colorectal.

Shield could become the second blood-based colon cancer diagnostic in the US following Epigenomics' Epi proColon, approved in 2016.

According to the FDA, colon or rectal cancer affects 150,000 Americans yearly and is the second highest cause of cancer deaths, with over 50,000 deaths.

Though colonoscopy is the gold standard for colon cancer screening, adherence is low due to its invasiveness. Fecus-related tests like Exact Sciences' Cologuard are also available, although blood tests are more convenient.

Panelists worried that Guardant's test wasn't as accurate as colonoscopy because Shield only found 13% of advanced adenomas.

According to FDA papers, Guardant's Shield application was based on a research that found 83% of colorectal malignancies, while Exact's Cologuard had 92.3% sensitivity.

Guardant Health executive Victoria Raymond stated at the meeting that the company anticipates the test will need to be repeated every one to three years. However, she emphasized that "colonoscopy should be the prioritized option."