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FDA has approved that the Guardant360 CDx in Guardant Health, Redwood City, Calif, the initial liquid biopsy companion diagnostic which additionally utilizes next-generation sequencing (NGS) technologies to identify patients with particular types of mutations of the epidermal growth factor receptor (EGFR) gene in a mortal kind of metastatic non-small cell lung cancer (NSCLC). This is the initial approval to combine two technology –NGS and liquid biopsy–in one diagnostic evaluation in order to guide therapy choices.
“Approval of a company diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new age for mutation testing,” states Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Along with benefiting from invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, instead of one biomarker at a time, which can translate to decreased wait times for beginning treatment and provide insight into possible resistance mechanisms.”
The Guardant360 CDx assay utilizes two technologies. The first is known as liquid biopsy, which uses a blood sample to offer health care professionals with genetic information regarding the individual’s tumor. It is less invasive and more easily repeatable compared to standard tissue biopsies. What’s more, liquid biopsy evaluations can be used in cases in which standard tissue biopsies are not feasible, for example, due to the positioning of the tumor.
The second technology is NGS, which utilizes large-panel genetic sequencing, called high-throughput tumor profiling. Compared to older technologies, NGS requires just one test so as to permit clinicians better assessment of tumor composition, giving suppliers an advantage in evaluating which mutations are debatable. The Guardant360 CDx assay employs NGS technologies to concurrently detect mutations in 55 tumor genes, rather than 1 gene at a time.
Though the Guardant360CDx can provide advice on several solid tumor biomarkers, today’s approval is unique to its use in identifying EGFR mutations in patients that will benefit from therapy with Tagrisso (osimertinib), an FDA-approved therapy for a kind of metastatic NSCLC. Lung cancer is the major cause of cancer-related death among men and women in the United States, also NSCLC is the most common type of lung cancer. Genomic findings for different biomarkers evaluated are not validated for choosing a particular corresponding remedy with this acceptance. If the particular NSCLC mutations linked with the current approval aren’t detected in the bloodstream, then a tumor biopsy should be performed to decide whether the NSCLC mutations are present.
The Guardant360 CDx assay was granted a Breakthrough Device designation, in which the FDA provides intensive discussion and guidance to the organization on effective apparatus development.
The FDA granted approval for the Guardant360 CDx test to Guardant Health. For more information, visit Guardant Health
