Everything you need to know about the new colon cancer blood test

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Colorectal cancer (CRC), commonly referred to as bowel cancer, is currently the second leading cause of cancer-related death in the US. But research shows that it is also highly treatable, especially if caught early. Now, a new blood test may make it much easier (and cheaper) to check for colon cancer symptoms.

This morning, the US Food and Drug Administration (FDA) approved Guardant Health's CRC blood test, Shield, which checks for signs of cancer in adults aged 45 and older. Although the test is not intended to replace traditional colonoscopies, the approval marks the first time any blood test has been approved as a primary screening option for CRC, and the first time any CRC blood test meets the requirements for Medicare coverage. That means the test could be more affordable for millions of elderly patients.

Here's everything you need to know about The Shield:

How does the Shield colon cancer test work?

The Shield is a non-invasive blood test, meaning it does not require any of the preparatory work (such as extended fasting) required for a colonoscopy. It detects cancer by looking for DNA released by cancerous tumors in the blood. The test is done in a doctor's office, and must be repeated every three years after age 45.

According to a study of 20,000 patients published in New England Journal of Medicine in March, the Shield was 83% effective in detecting colon cancer. The test was less sensitive in detecting early-stage polyps, which were detected only 13% of the time. Doctors emphasize that the Shield is only the first step: If the test finds signs of possible cancer, a colonoscopy will be needed to confirm the diagnosis and understand the seriousness of the case.

How much does it cost?

Prior to FDA approval, the out-of-pocket price for the test was $895. Guardant Health has not released updated self-pay cost information for the FDA-approved version of the test. However, with approval, Shield is more likely to be paid for by private insurance companies and Medicare plans for patients age 65 and older, so patients can avoid out-of-pocket costs entirely.

Fast company has reached out to Guardian Health for clarification on the new self-pay price for the test and will update this story accordingly.

What are my other options?

The company Exact Sciences offers a stool test called Cologuard. There is also another blood test called Epigenomics' Epi proColon, which was approved by the FDA in 2016, but that test did not meet the standards to be approved for Medicare coverage due to testing below the 74% cancer detection threshold.

And, of course, traditional colonoscopies are still the best way to detect colon cancer.

What should I know about colon cancer?

According to a press release from Guardian Health, the screening rate for colon cancer in the US is about 59%—well below the National Colorectal Cancer Roundtable's goal of 80%. “More than one in three eligible Americans – more than 50 million people – do not complete CRC screening, often due to the perception that other available options, such as colonoscopy or cell-based tests, are invasive, unpleasant or inconvenient,” the release said. he is studying.

But screening for CRC early and often can make a big difference for patients. “When colon cancer is detected early before it spreads, the five-year survival rate is 91%,” the release said. “If the cancer has spread to distant parts of the body, the five-year survival rate is 14%.

In interview no NBC NewsDr. Sapna Syngal, director of cancer prevention and early detection strategies at the Dana-Farber Cancer Center in Boston, said the “big problem” with breast cancer right now is that many Americans are not getting screened.

“If this test increases the number of people tested, it will have a big impact,” he said.

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