First liquid cancer biopsy product based on NGS technology approved!
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On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved Guardant 360 CDX, a liquid biopsy developed by Guardant Health Inc., for use in comprehensive genomic analysis of all solid tumor types. The FDA also approved Guardant 360 CDX as a concomitant diagnosis to identify patients with metastatic non-small cell lung cancer (NSCLC) who carry epidermal growth factor receptor (EGFR) gene mutations to help identify patients who would benefit from Tagrisso ® (osimertinib) therapy. This is the first FDA-approved diagnostic test that combines NGS and liquid biopsy technology to guide treatment decisions.
The Guardant360 CDX approval is based on clinical and analytical validation data from more than 5,000 samples. TAGRISSO is an FDA-approved treatment for metastatic NSCLC. In a retrospective analysis of the key phase III clinical trials FLAURA and AURA3, progression-free survival in patients identified as NSCLC patients receiving Tagrisso (osimertinib) using Guardant360 CDX was found to be consistent with conventional biomarker tests.
Guardant launched Guardant's first commercial blood cancer screening product, aimed at all advanced solid tumors, in 2014. The Guardant360 CDX test uses two techniques. The first is a liquid biopsy, which uses a blood sample to provide medical professionals with genetic information about a patient's tumor. It is less invasive, easier to repeat than a standard biopsy, and is suitable for patients with tumors where a standard biopsy is not available. The second technology is NGS. Guardant360 CDX uses large panel gene sequencing technology to conduct high-throughput tumor analysis, which can simultaneously detect mutations in 55 tumor genes. With only one test compared to earlier testing techniques, the test can help clinicians better assess tumor genetic mutations and provide patients with better treatment decisions.
"The approval of liquid biopsy and NGS technology for accompanying diagnosis marks a new era in mutation testing," said Tim Stenzel, MD, director of the Office of In Vitrology Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. In addition to benefiting from less invasive tests, patients can also obtain multiple biomarkers for genomic changes at the same time, rather than testing one biomarker at a time. This could reduce the waiting time for patients to start treatment and provide insight into possible resistance mechanisms."
It is important to note that although Guardant360 CDX provides biomarker information for a variety of solid tumors, this FDA approval is in identifying EGFR mutations in patients who would benefit from Tagrisso treatment. "Personalized medications such as Tagrisso have been life-changing for many NSCLC patients who have certain EGFR mutations and are most likely to benefit from them," said Dr. Jhanelle Gray, chair of the Department of Thoracial Oncology at Moffitt Cancer Center. It is vital that all patients are thoroughly tested before starting treatment to ensure they have access to the most appropriate personalised treatment."
Since its establishment in 2012, Guardant Health has gradually expanded its business into the field of cancer prognosis monitoring and early screening, starting from the treatment guidance program for patients with advanced cancer. In October 2018, Guardant Health was listed on the Nasdaq Stock Exchange in New York. The company has launched Guardant360® and Guardantomni ® tests based on liquid biopsies for patients with advanced cancer. Of these, Guardant360 has been widely used for comprehensive blood-based genetic analysis by more than 150 peer-reviewed publications since its introduction as a laboratory homegrown project (LDT). To date, more than 7,000 oncologists have performed more than 150,000 Guardant360 tests. The test is widely covered by health insurance, benefiting more than 170 million lives.
In addition, Guardant's liquid biopsy test is a major driver of its Lunar program for early cancer screening and cancer surveillance. The Lunar 1 project, launched in 2016, aims to develop a method for detecting tumor recurrence. The LUNE-2 program aims to develop an accurate blood test for early cancer to help patients detect the disease as early as possible. Progress on each of these platforms is synergistic. For example, Guardant360's data and algorithms will support Guardantomni's research and development, while advances in these two platforms will drive the ongoing Lunar 1 and Lunar 2 programs.
"FDA's approval of Guardant360 CDX is a landmark decision that demonstrates the value that liquid biopsies bring to oncologists as well as cancer patients," said Dr. Helmy Eltoukhy, CEO of Guardant Health. Traditional tumor analysis based on biopsy is often invasive and requires longer turnaround times, which can lead to delayed treatment or failure to optimally treat patients. We applaud the FDA's collaborative review process and approval of the first liquid biopsy to perform a comprehensive genome-mapping analysis. FDA approval will help accelerate the wider adoption of the genomic analysis recommended by the guidelines, enable more patients with advanced cancer to receive better treatment, and pave the way for Guardant360 CDX's new companion diagnostic approach."
The FDA has already approved more new targeted therapies and companion diagnoses in 2020 than in previous years. Clinical studies have shown that patients receiving targeted therapies have improved progression-free survival and a higher overall remission rate compared to chemotherapy or immunotherapy. However, clinical adoption of targeted therapies still lags behind medical guidelines due to a number of factors. It is believed that with the decline of sequencing price and the rapid development of omics technology and tumor liquid biopsy in the world, accurate diagnosis and targeted therapy guidance based on blood will only accelerate, which will also promote precision medicine to a new era.
