Guardant Health, Inc. announced certification for its Guardant360® CDx blood test under the European Union's In Vitro Diagnostic Regulation (IVDR 2017/746). The certification fromTUV SUD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer. Under the previous EU regulatory framework (IVD Directive 98/79/EC), manufacturers were able to self-certify most of their molecular assays.

Under the IVDR most must obtain a conformity assessment and certificate from an accredited company, called a notified body, such as TÜV SÜD. Guardant360 CDx is a next generation sequencing (NGS)-based assay that detects genomic alterations using circulating tumor DNA from blood. The test allows clinicians to use tumor mutation profiling, also known as comprehensive genomic profiling (CGP), to identify somatic mutations in solid tumors from a simple blood draw to inform personalized treatment decisions for their patients with advanced cancer. Under the IVDR, Guardant360 CDx is certified as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT® (amivantamab), or LUMYKRAS® (sotorasib), and advanced breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU?

(elacestrant). Personalized medicines such as these have been life-changing for many cancer patients who have targetable mutations and are thus most likely to benefit from a particular therapy. IVDR certification for Guardant360 CDx is significant because it ensures continued broad access in the EU to comprehensive genomic profiling, which plays a critical role in helping biopharma companies identify patients to enroll in clinical trials and helping oncologists match patients to new precision medicines that target solid tumors.