The FDA has approved a blood test called Shield, developed by Guardant Health, allowing for colorectal cancer screening in individuals aged 45 and older at “average risk.”
The Shield blood test is not meant to replace colonoscopies but offers a quicker and more accessible screening option, potentially encouraging more people to get screened for colon cancer.
The big picture: Results from clinical trials showed that Shield had an 83.1% sensitivity rate in detecting colorectal cancer, with an 89.9% specificity rate for patients without cancer.
- While Shield presents an additional screening option, colonoscopies remain the gold standard for screening due to their higher accuracy in detecting cancer and precancerous polyps.
- The blood test detects colorectal cancer by identifying DNA shed by tumors in blood samples, with results typically available within two weeks.
- Despite concerns about the potential for false negatives, the FDA advisory panel recommended and approved the Shield test, emphasizing its safety and effectiveness in cancer detection.
What they’re saying: “The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable,” Guardant Health co-CEO AmirAli Talasaz said in a statement.
- “We are now getting ready to launch this test in the near future and are very excited to empower physicians with a viable blood-based screening option to tailor the screening regimen to the unique needs of their patients,” Talasaz said.
