FDA approves new blood test for colorectal cancer screening

A new blood test to screen for colon cancer was approved Monday by the Food and Drug Administration (FDA), with the goal of finding cancer at an early, treatable stage.

The blood test, known as Shield and manufactured by Guardant Health, has been on the market since 2022 but was not widely covered by private insurance, so patients often had to pay the entire $895 cost out of pocket. FDA approval will likely increase coverage and access.

Shield is available to eligible individuals upon prescription from a physician or other healthcare professional and is expected to be covered for eligible Medicare beneficiaries. It has been approved for people aged 45 and over with “average risk” of colon cancer.

Colorectal cancer is the second leading cause of cancer-related death in the US, although it is highly treatable if detected early.

Shield is the first blood test approved by the FDA as a primary screening option for colorectal cancer, the manufacturer said.

It is also the first approved blood test for colorectal cancer that meets Medicare reimbursement requirements.

According to the American Cancer Society, when colon cancer is found at an early stage, before it has spread, the five-year relative survival rate is 91%. If the cancer spreads to distant parts of the body, the five-year relative survival rate is 14%.

Current guidelines recommend screening starting at age 45, but more than 1 in 3 eligible Americans – more than 50 million people – do not complete the screening, often due to the perception that other options are available, such as colonoscopy or stool tests. , are invasive, unpleasant or inconvenient.

According to the company, the overall adoption rate for the Shield test was over 90%. In contrast, studies show that only 28% to 71% of patients prescribed other screening methods, such as colonoscopy or a stool test, complete them.

“This is a promising step toward making more convenient tools available to detect colorectal cancer early while making it more easily treated,” said William M. Grady, a gastroenterologist at Fred Hutchinson Cancer Center, in a statement released Monday by Guardian Health.

Grady said in the release that the test has a similar accuracy rate to stool tests used for early cancer detection.

But the test has a drawback: Based on clinical trial data, Shield has limited detection of stage I colorectal cancer and misses 87% of precancerous lesions. It was much better at detecting later stage cancers.

The test is based on the detection of DNA released by tumors into the bloodstream; therefore, the larger the tumor, the more DNA it releases.

If the results indicate the presence of cancer, patients will still need a colonoscopy so doctors can see where the tumors are and how far they have progressed, the company said.

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