Despite the high overall sensitivity rate, the clinical trial data indicated Shield may miss one in 10 people who have precancerous lesions and one in 1,000 people with cancerous lesions.
These “false negatives” may result in tests finding no evidence of cancer, but patients actually have precancerous or cancerous lesions, according to the clinical trial data.
Although members of the MDAC did express concerns about false negatives, the committee ultimately found the test to be safe and effective and that the benefits of use outweighed potential risks.
“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,” AmirAli Talasaz, Guardant Health co-CEO, said in a press release.
“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.
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