Guardant360 CDx: A Breakthrough in Tumor Profiling and Personalized Cancer Treatment
Key Takeaways
- Guardant360 CDx gains EU certification for tumor profiling in solid tumors.
- The test aids oncologists in personalizing treatment for NSCLC and breast cancer.
- This certification will accelerate the adoption of comprehensive genomic profiling across the EU.
Did You Know?
Introduction
Guardant Health has achieved a significant milestone with the certification of its Guardant360 CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). This approval marks a turning point in tumor mutation profiling for patients with solid tumors.
What is Guardant360 CDx?
Guardant360 CDx is a comprehensive genomic test that utilizes a simple blood draw to provide detailed genomic information. By analyzing circulating tumor DNA (ctDNA) within 7 days, the test identifies somatic mutations in solid tumors, offering a faster and less invasive option compared to traditional biopsies.
Certification and Its Importance
The certification by TÜV SÜD Product Service under the IVDR framework is a critical achievement. It signifies that the Guardant360 CDx test meets the stringent quality standards required for diagnostic tools in the EU. This ensures broad accessibility and reliability for oncologists and their patients.
Companion Diagnostic Use
This certification extends Guardant360 CDx’s utility as a companion diagnostic. It can now be used to identify patients with non–small cell lung cancer (NSCLC) who may benefit from targeted treatments such as osimertinib (Tagrisso), amivantamab-vmjw (Rybrevant), or sotorasib (Lumakras). Additionally, it identifies advanced breast cancer patients harboring ESR1 mutations to benefit from elacestrant (Orserdu).
Clinical Impact
According to Helmy Eltoukhy, PhD, Guardant Health’s chairman and co-CEO, this certification will accelerate the adoption of genomic profiling. This paves the way for developing new targeted therapies and increasing the number of patients receiving life-changing treatments. The quick and accurate results from Guardant360 CDx enable clinicians to personalize treatment plans more effectively.
Global Recognitions
Since its inception, the Guardant360 CDx test has been approved and recognized globally. In August 2020, the U.S. FDA approved it for comprehensive genomic profiling for any solid malignancy and as a companion diagnostic for detecting EGFR mutations in NSCLC patients who could benefit from osimertinib.
Adoption and Usage
Guardant360 CDx has been validated and widely accepted in the oncology community. Over 12,000 oncologists have used it in more than 500,000 tests. It has also been featured in over 400 peer-reviewed publications, showcasing its reliability and effectiveness in guiding cancer treatment.
Future Implications
The new IVDR framework elevates the standards for diagnostic tools, enabling better cancer care. This ensures that oncologists are equipped with highly validated and trusted tools, which helps in finding more actionable biomarkers for future treatments.
Expert Opinions
Peter Fasching, MD, a leading professor in obstetrics and gynecology, emphasizes the importance of high-quality standards in diagnostic tools. Using IVDR-certified liquid biopsies more broadly can aid in identifying biomarkers and tailoring treatment plans with greater precision.
Conclusion
Guardant360 CDx’s certification is a significant step forward in cancer care across the EU. It promises to enhance the capabilities of oncologists in offering precise, personalized treatments, ultimately improving outcomes for patients with advanced cancers.
