2023’s best medtech innovations
Category: Best Medical Technology
Winner: Guardant360 CDx
Guardant Health’s Guardant360 CDx [Photo courtesy of Guardant Health]
In 2020, the FDA approved the Guardant360 CDx blood test for tumor mutation profiling (also known as comprehensive genomic profiling, or CGP) to detect cancer biomarkers.
Guardant360 CDx was the first blood test approved by the FDA for CGP. The minimally invasive diagnostics requires two tubes of blood and delivers results within a week.
Redwood City, California-based Guardant says the product “detects actionable biomarkers in 55 FDA-approved, clinically relevant genes.”
The laboratory test is “designed to detect gene mutations found in circulating cell-free DNA (cfDNA),” the FDA explains. “This test helps doctors identify patients with non-small cell lung cancer who may benefit from specific FDA-approved treatments.”
After winning FDA premarket approval in 2020, Guardant Health co-founder Helmy Eltoukhy called the regulator’s move a “landmark decision, demonstrating the value liquid biopsy delivers to oncologists and, more importantly, the patients they treat.”
“Traditional tissue biopsy-based tumor profiling, which is often invasive and has longer turnaround times, can contribute to delays in starting treatment and possibly suboptimal therapy,” he continued. “… We are confident that our FDA approval will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments for the Guardant360 CDx.”
Eltoukhy is now Guardan’s board chair and co-CEO, sharing leadership responsibilities with co-founder and co-CEO AmirAli Talasaz. Talasaz was previously senior director of diagnostics research at Illumina, where Eltoukhy was senior director of advanced technology research.
