Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications

Original from: Guardant Health

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD 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.

“The IVDR certification for the Guardant360 CDx liquid biopsy is a significant milestone for cancer care in the EU, as the test provides faster access to comprehensive genomic profiling for oncologists and, more importantly, for the patients they treat,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “We are confident that this certification will help accelerate wider adoption of guideline-recommended genomic profiling, pave the way for the development of new targeted therapies, and increase the number of advanced cancer patients who receive potentially life-changing treatments.”

More than 1.2 million people are predicted to die from cancer in the EU in 2024,1 many of whom could benefit from comprehensive genomic profiling to guide a more personalized treatment plan, based on the growing availability of effective CGP-informed targeted therapies. Clinical studies show that patients receiving targeted therapies have improved progression-free survival and higher overall response rates relative to chemotherapy or immunotherapy.

“Clinical adoption of targeted therapies lags behind medical guidelines due to several factors, including insufficient tissue for molecular profiling, which is the case for as many as 30 percent of solid cancer patients,” said Nicola Normanno, MD, scientific director of IRCCS Romagna Institute for the Study of Tumors (IRST) "Dino Amadori" in Meldola, Italy.9-11 “Expanding the use of genomic profiling with IVDR-certified liquid biopsy will help the cancer care community establish more clinically relevant biomarkers to improve diagnosis and quickly identify the personalized therapies that patients can benefit from.”

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.

“I am pleased that the new IVDR framework provides strict and high quality standards for diagnostic tools, because this will contribute to better standard of care and clinical trial protocols,” said Peter Fasching, MD, professor of Obstetrics and Gynecology and coordinator of the Breast Cancer Center and the Gynecological Cancer Center at the Comprehensive Cancer Center Erlangen-EMN, Germany. “Using IVDR-certified liquid biopsy more broadly will allow us to find more biomarkers that can be targeted in the future and gives clinicians confidence that they are using a highly validated tool to select the optimal individualized treatment plan for the patient.”

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling, with more than 400 peer-reviewed publications. It has been used by more than 12,000 oncologists, with more than 500,000 tests performed to date.

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Source: Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications