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Expert Advisory Opinion
Goldbug’s unique approach to solving the most vexing regulatory challenges has consistently produced unprecedented outcomes for our clients. I am proud of the value we bring to the diagnostic community and look forward to further enabling their success in advancing precision medicine.
Guardant Health Releases Results from ECLIPSE
https://investors.guardanthealth.com/press-releases/press-releases/2022/Guardant-Health-announces-positive-results-from-pivotal-ECLIPSE-study-evaluating-a-blood-test-for-the-detection-of-colorectal-cancer/default.aspx Last week, Guardant Health released the results of...
Johns Hopkins Research Team Publishes Findings from Novel AI Blood Test for Liver Cancer Detection
https://www.hopkinsmedicine.org/news/newsroom/news-releases/novel-ai-blood-test-detects-liver-cancer A research team led by Johns Hopkins Kimmel Cancer Center developed a circulating cell-free DNA (cfDNA) "fragmentome" and machine learning approach to boost...
FDA Explores Alternatives to CDx with New Pilot Program
https://www.fiercebiotech.com/medtech/fda-looks-bypass-cancer-drugs-companion-diagnostics-new-pilot-program-pazdur FDA had begun exploring ways around the one-drug-one-test limitations of companion diagnostics by looking further into the ‘minimal performance criteria’...