1. FDA granted Breakthrough Device designation to Guardant's Shield MCD test. 2. Shield MCD test shows 98.6% specificity and 75% sensitivity for multiple cancers. 3. NCCN included Shield in updated colorectal cancer screening guidelines. 4. ECLIPSE study demonstrated 83% sensitivity for CRC detection with the Shield test. 5. GH stock rose 10.4% to $46.49 following this positive news.
The FDA's Breakthrough Device designation signals significant regulatory support for Guardant's innovative technology, similar to historical boosts seen by companies like Illumina after similar approvals.
The article highlights crucial FDA approvals and clinical validations, which directly impact Guardant's market position and investor confidence.
The ongoing adoption of Shield in clinical guidelines ensures sustained interest and potential revenue growth over the long-term, as seen with competitors like Exact Sciences post-CDC endorsement.