Guardant Health’s Blood Test for Colorectal Cancer Screening Faces FDA Evaluation

Guardant Health is preparing for a significant milestone as its Shield test, designed for the detection of colorectal cancer through blood samples, heads for evaluation by the FDA. The agency scheduled an advisory panel meeting on May 23, 2023, to assess the in vitro diagnostic approval sought by Guardant for screening individuals aged 45 and above with an average risk of developing colorectal cancer. This marks a crucial step in potentially revolutionizing how colorectal cancer screening is conducted, offering a noninvasive alternative to traditional methods.

The Shield test, which has already been available since mid-2022 as a prescribed lab-developed test, has garnered attention for its ability to identify colorectal cancer and precancerous lesions with high accuracy, as demonstrated in the company's ECLIPSE study. With colorectal cancer being a leading cause of cancer-related deaths in the U.S., Guardant's innovative approach holds promise in improving early detection rates and subsequently enhancing treatment outcomes. As the company navigates the regulatory process and seeks endorsement from bodies like the U.S. Preventive Services Task Force, it aims to provide patients and healthcare providers with valuable screening choices to enhance overall compliance rates and mitigate the impact of this deadly disease.

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