Palo Alto

FDA approves Bay Area company's colon cancer screening test

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The Food and Drug Administration on Monday approved a new colon cancer screening method developed by a Bay Area company that makes it as easy as taking a blood test.

Palo Alto-based Guardant Health has developed a shield test, and while it doesn't replace the highly effective and accurate tests many people dread, it’s a great way to get those who have completely avoided colonoscopies to screen for colon cancer.

"We know that many people remain unscreened with the current choices, including a colonoscopy for various reasons," said Dr. Craig Eagle, chief medical officer for Guardant Health. "Adding a choice of a blood test will give more people the option to get screened."

It's a critical element to fighting colon cancer, which the American Cancer Society estimates will kill as many as 53,000 people this year.

While the test itself is not new, FDA approval means that Medicare and private insurance companies will be far more likely to cover the cost, making it more widely accessible for patients. The new screening is meant for people 45 and older who have average risk of colon cancer.

Research published in March showed the shield test was 83% effective in finding colorectal cancers.

"This test picks up the signal of cancer DNA in the bloodstream," Eagle said. "So, therefore alerting the person to the presence of cancer cells and with that alert go on and have a colonoscopy."

John Gormly of Newport Beach said the screening saves his life when he went in for a routine checkup a few years ago.

"We had the test, the results came back positive and [my doctor] didn't like the results. So I went off and got the colonoscopy and found out I had stage two cancer," Gormly said. "They operated and took it out."

The company stresses the shield test is not meant to be replace colonoscopies, but is generating enthusiasm among doctors who say it could increase screening rates.

Guardant Health hopes it will save more lives in the years to come.

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