Three years ago, when I first met the top executives at Guardant Health, it was clear that this precision oncology company was on a mission to make things easier and better for cancer patients.
Yesterday, a big part of that mission was realized when the company announced that its new Shield blood test for colorectal cancer was approved by the Food and Drug Administration (FDA).
Shield is the first blood test approved by the FDA as a primary test for colorectal cancer that offers an easy and convenient screening option with potential for improving colorectal cancer screening rates.
With this test, Guardant is hoping to change the dynamic of colorectal cancer by providing non-invasive screening in adults aged 45 and older who are at average risk for the disease.
Many of our readers know exactly how devastating a colorectal cancer diagnosis can be and how uncomfortable these tests can be. Colorectal cancer is the second-leading cause of cancer-related death in the United States. But this new test brings new hope.
Millions of Americans still don’t know that colorectal cancer is actually treatable if caught early, according to the American Cancer Society.
This new test could change the landscape and convince more folks to get tested.
Shield is the first blood test to be approved by the FDA as a primary screening option for colorectal cancer, meaning health-care providers can offer Shield in a manner similar to all other noninvasive methods recommended in screening guidelines.
And that’s the key: it’s noninvasive. This is a breakthrough that will likely bring many more patients into the clinic to be tested. Shield is also the first blood test for colorectal cancer screening that meets the requirements for Medicare coverage.
This is not a replacement for a colonoscopy, but this test should convince more people to get checked.
In a call with investors, Guardant co-CEO AmirAli Talasaz said 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. 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.”
William M. Grady, MD, a gastroenterologist at Fred Hutchinson Cancer Center, said in a press statement, “This is a promising step toward making more convenient tools available to detect colorectal cancer early while it is more easily treated. The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options.”
Daniel Chung, MD, a gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, said in a press statement, “The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people.”
Chung added that the approval of the Shield blood test marks a “tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved.”
Dennis Barnes, a 55-year-old attorney whose physician had recommended a colonoscopy, said in a press statement, “Most people in my situation know we’re supposed to get screened for colon cancer. It’s hard to find the time to schedule it if you have a busy life and a demanding job.”
When his doctor told Barnes about Shield, Barnes agreed to have the blood test and was fortunate to have the result come back normal. “I realized I had taken quite a risk by waiting so long to screen. The Shield test is a much more pleasant way to screen, and the convenience of it makes getting screened pretty much a no-brainer,” he said.
Shield is available for eligible individuals by prescription through a doctor or other healthcare professional and is expected to be covered for eligible Medicare beneficiaries.
Commercial insurance coverage for patients eligible for CRC screening will continue to expand following anticipated future guideline inclusion by the American Cancer Society and the U.S. Preventive Services Task Force.
