Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications
- Blood-based test for comprehensive genomic profiling of solid cancers meets requirements under stricter EU In Vitro Diagnostic Regulation
- IVDR certification from TÜV SÜD enables broader adoption of guideline-recommended genomic profiling to inform optimal therapy selection for patients with advanced 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
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.2-8
“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
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
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.
About Guardant360 CDx
The first FDA-approved blood test for complete genomic testing, Guardant360 CDx received
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended
References
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- Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis. Ann Oncol. 2019;30(5): v851-v934.
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Hagemann IS, Devarakonda S, Lockwood CM, et al. Clinical Next-Generation Sequencing in Patients with Non–Small Cell
Lung Cancer . Cancer. 2015;121:631-639. - Parsons HA, Beaver JA, Cimino-Mathews A, et al. Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer. Cancer Res. 2017;23(2); 379–386.
- Wyatt AW, Annala M, Aggarwal R, et al. Concordance of Circulating Tumor DNA and Matched Metastatic Tissue Biopsy in Prostate Cancer. J Natl Cancer Inst. 2018;110(1):djx118.
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