Guardant Health Earns EU IVDR Certification for Guardant360® CDx Liquid Biopsy

Guardant Health Inc., a prominent name in precision oncology, has secured certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). TÜV SÜD Product Service awarded the certification for tumor mutation profiling in patients with any solid tumors and for companion diagnostic indications to identify patients who may benefit from targeted therapies for advanced non-small cell lung cancer and breast cancer.

The previous EU regulatory framework (IVD Directive 98/79/EC) allowed manufacturers to self-certify most molecular assays. However, the IVDR mandates that most tests must now obtain a conformity assessment and certificate from a notified body, such as TÜV SÜD. Guardant360 CDx, an NGS-based assay, detects genomic alterations using circulating tumor DNA from blood. This innovative test allows clinicians to use comprehensive genomic profiling (CGP) to identify somatic mutations in solid tumors via a simple blood draw, aiding in personalized treatment decisions for patients with advanced cancers.

Helmy Eltoukhy, the chairman and co-CEO of Guardant Health, remarked that the IVDR certification for the Guardant360 CDx liquid biopsy marks a considerable milestone for cancer care in the EU. He emphasized that this certification would facilitate faster access to CGP for oncologists and their patients, potentially accelerating the adoption of guideline-recommended genomic profiling, paving the way for new targeted therapies, and increasing the number of advanced cancer patients receiving potentially transformative treatments.

In the EU, over 1.2 million cancer deaths are predicted in 2024, many of whom could benefit from CGP to guide personalized treatment plans. Clinical evidence suggests that patients receiving targeted therapies exhibit improved progression-free survival and higher overall response rates compared to chemotherapy or immunotherapy.

Nicola Normanno, MD, from the IRCCS Romagna Institute for the Study of Tumors in Italy, highlighted that clinical adoption of targeted therapies is slower than medical guidelines recommend, partly due to inadequate tissue for molecular profiling in about 30 percent of solid cancer patients. Expanding genomic profiling with the IVDR-certified liquid biopsy can help establish more clinically relevant biomarkers, improving diagnosis and swiftly identifying personalized therapies that benefit patients.

The Guardant360 CDx is certified under IVDR as a companion diagnostic to identify patients with non-small cell lung cancer who might benefit from treatments like TAGRISSO® (osimertinib), RYBREVANT® (amivantamab), or LUMYKRAS® (sotorasib), and advanced breast cancer patients with ESR1 mutations who could benefit from ORSERDU™ (elacestrant). These personalized medicines have had impactful outcomes for many cancer patients with targetable mutations, ensuring continued broad access in the EU to comprehensive genomic profiling, which is crucial for matching patients to precision medicines.

Peter Fasching, MD, from the Comprehensive Cancer Center Erlangen-EMN in Germany, expressed satisfaction with the new IVDR framework, which he believes will lead to better standards of care and clinical trial protocols. He noted that broader use of IVDR-certified liquid biopsy would help discover more biomarkers that can be targeted in the future, providing clinicians with a validated tool to select the best individualized treatment plans for patients.

Since its introduction, the Guardant360 test has gained wide acceptance for blood-based comprehensive genomic profiling, with over 400 peer-reviewed publications and use by more than 12,000 oncologists, performing over 500,000 tests to date.

Guardant360 CDx, the first FDA-approved blood test for complete genomic testing, received U.S. FDA approval in August 2020 and CE mark for tumor mutation profiling in March 2021. The test provides comprehensive genomic results from a blood draw in seven days, overcoming the limitations of tissue biopsies and enabling rapid, clinically relevant information to match patients to optimal personalized treatments. It covers all genes recommended by the National Comprehensive Cancer Network, including those crucial for clinical care and NSCLC treatment guidelines.