FDA Approves Shield Test: New Blood Test Revolutionizes Colorectal Cancer Screening for Ages 45+
July 30, 2024The FDA has approved a new blood test called Shield for screening colorectal cancer, aimed at individuals aged 45 and older who are at average risk.
Developed by Guardant Health, the Shield test aims to provide a less invasive alternative to traditional colonoscopies, making screening easier compared to fecal sample tests.
The goal of the Shield test is to improve screening rates for colorectal cancer, which can be performed easily during routine doctor visits.
Colorectal cancer remains a significant health concern, being the second-highest cause of cancer death in the U.S., with an estimated 53,000 deaths expected this year.
Despite current guidelines recommending screenings starting at age 45, fewer than 60% of eligible individuals are screened, highlighting a critical gap in early detection.
Experts emphasize that increasing screening rates could have a substantial impact on reducing colorectal cancer deaths, which are preventable through regular screening.
Challenges in screening compliance often stem from life responsibilities and the perceived inconvenience of colonoscopy preparation, which the Shield test aims to address.
Patients are recommended to receive the Shield test every three years, aligning with the recommended age for colorectal screening.
While the Shield test shows 83% sensitivity in detecting colorectal cancer, it has limitations, including a 10% false positive rate and low sensitivity for advanced precancerous polyps.
Health professionals stress the importance of confirming positive results from the Shield test with a follow-up colonoscopy to ensure accurate diagnosis.
Despite its limitations, the approval of the Shield test is seen as a potential catalyst for improving screening rates among those hesitant about traditional methods.
Guardant Health's shares have increased by 25% this year, reflecting investor confidence in the potential impact of the Shield test on cancer screening.
Summary based on 10 sources
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Sources
The New York Times • Jul 29, 2024
F.D.A. Approves Blood Test for Colon Cancer DetectionNBC News • Jul 29, 2024
FDA approves new blood test to screen for colon cancerInvestopedia • Jul 29, 2024
Guardant Health Gets FDA Nod on Colorectal Cancer Blood TestQuartz • Jul 29, 2024
A new blood test for colon cancer just got approved by the FDA