FDA Approves New Colorectal Cancer Blood Test for Early Detection, but with Limitations

FDA approved a new blood-based colorectal cancer screening test by Guardant Health. 

The Food and Drug Administration has given the green light to a novel colorectal cancer screening test that uses only a blood sample. This innovative test, developed by Guardant Health of Palo Alto, Calif., has the ability to detect colorectal cancers in their early, and most treatable, stages.

Blood Test for Colon Cancer Detection

The new screening method offers a less invasive alternative to the traditional colonoscopy or fecal sample test, as it only requires a blood sample. This is a significant advantage for individuals who may find it challenging to undergo the more intrusive conventional screenings.

Limitations and Availability

Although the Shield test, as it is named, has demonstrated effectiveness in detecting early-stage colorectal cancer, it is important to note that it has limitations. Unlike other screening methods, the Shield test has shown a poor track record in identifying precancerous growths, which can be essential in preventing the development of cancer.

Despite this limitation, the Shield test is set to be rolled out imminently, with an expected availability within a week of its approval. Guardant Health will disclose the list price of the test upon its release, providing more insight into its potential accessibility and affordability.

Target Audience and Public Health Impact

The newly approved blood test is specifically targeted at individuals aged 45 and above who are at an average risk of developing colorectal cancer. The widespread hope is that the availability of this less invasive screening option will encourage more people to undergo colorectal cancer screening, ultimately leading to early detection and a reduction in colorectal cancer-related deaths.

Colorectal cancer is the second most common cause of cancer-related deaths in the United States, with an estimated 53,000 deaths expected this year alone. Encouraging more individuals to undergo screening, even with the limitations of the Shield test, could have a significant impact on reducing the mortality rate associated with colorectal cancer.

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