An FDA advisory panel has recommended approval of Guardant Health's Shield blood test for colorectal cancer screening, citing its safety and effectiveness. The test, which detects DNA from tumors in blood samples, could provide a less invasive alternative to colonoscopies and stool tests, potentially increasing screening rates. However, concerns remain about its ability to detect precancerous lesions and the possibility of false negatives. The FDA is expected to decide on the approval in 2024.
An FDA advisory panel has endorsed the safety and effectiveness of Guardant Health's new blood test, Shield, for screening colon and rectal cancers, despite its limitations compared to colonoscopies. The test detected 83% of colorectal cancers but only 13% of dangerous polyps, whereas colonoscopies find 95% of such polyps. The panel hopes the blood test will increase screening rates, though it must be followed by a colonoscopy if abnormalities are found.
An FDA advisory panel has recommended the approval of Guardant Health's blood test, Shield, for detecting colorectal cancer. If approved, it would be the second blood-based test for this cancer in the U.S. after Epi proColon. While Shield is seen as more convenient than colonoscopy, concerns were raised about its lower accuracy, particularly in detecting pre-cancerous tumors. The test detected 83% of colorectal cancers in studies, compared to 92.3% for Exact Sciences' Cologuard.
Guardant Health's Shield blood test for colorectal cancer screening is a step closer to FDA approval after an advisory panel voted on its safety and effectiveness. If approved, it would be the first blood test for colorectal cancer covered by Medicare, offering a non-invasive alternative to current screening methods like colonoscopies and stool tests. The test has shown around 83% sensitivity and 90% specificity in detecting colorectal cancer, though it is less effective at identifying precancerous lesions.
The first blood test for colorectal cancer, called Shield, could be approved this year, potentially increasing the number of diagnoses for the second-highest cause of cancer death in the US. While not a replacement for colonoscopies, the blood test offers a less invasive way to detect colon cancer, addressing barriers such as the "ick" factor and logistical issues associated with colonoscopies. The test, developed by Guardant Health, was found to be 83% effective in detecting colorectal cancers, but less effective in finding early stage polyps. If approved by the FDA, the test would be given every three years starting at age 45, with colonoscopies still necessary for those with symptoms or family history of the disease.
Jim Cramer, host of CNBC's "Mad Money," shared his thoughts on several stocks during his lightning round segment. He expressed optimism about SoFi, stating that he remains a buyer and believes CEO Anthony Noto is doing a great job. Cramer also discussed Barrick Gold, Generac, Golden Ocean, and Guardant Health, providing insights on their performance and potential. However, he advised caution with Golden Ocean due to its historical boom and bust nature, and recommended considering Danaher over Guardant Health for gene sequencing investments. Additionally, Cramer suggested that Walgreens needs to present a plan and cut its dividend in order to regain his recommendation.
