Guardant Health is working to expand cancer screening with a blood test, aiming to catch the disease before symptoms appear. The company’s Shield blood test for colorectal cancer screening has been at the forefront of early cancer detection efforts, winning FDA approval in 2024 for people aged 45 or older who are not at high risk for the disease.
Colorectal Cancer Screening
The Shield test detects colorectal cancer-derived alterations in cell-free DNA in the blood. However, the FDA emphasizes that it is not a replacement for colonoscopy due to limited effectiveness in detecting Stage I cancer and precancerous lesions. A competing test from Freenome was approved by the FDA for the same indication.
Blood-based screening for colorectal cancer gained an endorsement this year from the American Cancer Society for patients who are not willing to get a stool test or visual exam. UnitedHealthcare, the largest private U.S. insurer, recently agreed to cover Shield for its enrollees.
Guardant is also expanding Shield into multicancer detection, following the FDA’s breakthrough device designation for the test. Sam Asgarian, the company’s vice president of clinical development, discussed the company’s progress in blood-based colorectal cancer screening and multicancer strategy.
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Asgarian noted that the Shield test is generating strong volume and revenue growth for Guardant, with hundreds of thousands of people tested already. Most patients screened are previously unscreened, and physicians are offering the test to those who have hesitated to undergo colonoscopy.
They are working to improve the test’s sensitivity, particularly for detecting Stage I cancer and precancerous lesions.
Guardant is exploring new science to capture more markers in the blood. Asgarian stated that the FDA did not approve Shield for precancerous lesion detection, but they want to invest in innovative science to improve the test’s performance.
In multicancer detection, Guardant has taken a different approach than Grail. Shield covers several common cancers.
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The company hopes to produce more data on the test’s performance and potentially pursue FDA approval for the Shield multicancer test. Asgarian stated that Guardant has always wanted FDA approval for its screening solutions and will continue to gather real-world evidence on the test’s performance.
It remains committed to improving its test and expanding cancer screening capabilities.
As the science continues to evolve, Guardant’s efforts to improve cancer screening may lead to better outcomes for patients.
Guardant’s focus on innovative science and collaboration with healthcare providers may help increase screening rates and detect cancer earlier, when it is more treatable.
