Case 1:20-cv-01580-LPS Document 9-1 Filed 12/10/20 Page 1 of 3 PageID #: 703
`Case 1:20-cv-01580-LPS Document 9-1 Filed 12/10/20 Page 1 of 3 PageID #: 703
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`EXHIBIT 1
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`EXHIBIT 1
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`Case 1:20-cv-01580-LPS Document 9-1 Filed 12/10/20 Page 2 of 3 PageID #: 704
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`FDA NEWS RELEASE
`FDA Approves First Liquid Biopsy Next-Generation
`Sequencing Companion Diagnostic Test
`
`For Immediate Release:
`August 07, 2020
`
`This release was updated on Aug. 11, 2020 to clarify the intended use of the Guardant360 CDx.
`
`Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion
`diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with
`specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly
`form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two
`technologies — NGS and liquid biopsy — in one diagnostic test in order to guide treatment
`decisions.
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`“Approval of a companion diagnostic that uses a liquid biopsy and leverages next-
`generation sequencing marks a new era for mutation testing,” said Tim Stenzel,
`M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health
`in the FDA’s Center for Devices and Radiological Health. “In addition to
`benefitting from less invasive testing, patients are provided with a simultaneous
`mapping of multiple biomarkers of genomic alterations, rather than one
`biomarker at a time, which can translate to decreased wait times for starting
`treatment and provide insight into possible resistance mechanisms.”
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`The Guardant360 CDx assay utilizes two technologies. The first is called liquid biopsy, which
`uses a blood sample to provide health care professionals with genetic information about the
`patient’s tumor. It is less invasive and more easily repeatable in comparison to standard tissue
`biopsies. Furthermore, liquid biopsy tests can be used in cases in which standard tissue biopsies
`are not feasible, for instance, due to the location of the tumor.
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`The second technology is NGS, which uses large-panel genetic sequencing, known as high-
`throughput tumor profiling. Compared to older technologies, NGS requires only one test in
`order to allow clinicians better assessment of tumor composition, giving providers an advantage
`in evaluating which mutations are problematic. The Guardant360 CDx assay uses NGS
`technology to simultaneously detect mutations in 55 tumor genes, rather than one gene at a
`time.
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`Case 1:20-cv-01580-LPS Document 9-1 Filed 12/10/20 Page 3 of 3 PageID #: 705
`The Guardant360CDx is approved both to provide information on multiple solid tumor
`biomarkers and to help identify EGFR mutations in patients who will benefit from treatment
`with TAGRISSO (osimertinib), an FDA-approved therapy for a form of metastatic NSCLC. Lung
`cancer is the leading cause of cancer-related death among men and women in the United States,
`and NSCLC is the most common type of lung cancer. Genomic findings for other biomarkers
`evaluated are not validated for choosing a particular corresponding treatment with this
`approval. If the specific NSCLC mutations associated with today’s approval are not detected in
`the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are
`present.
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`The Guardant360 CDx assay was granted a Breakthrough Device designation, in which the FDA
`provides intensive interaction and guidance to the company on efficient device development.
`
`The FDA granted approval for the Guardant360 CDx test to Guardant Health.
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the
`public health by assuring the safety, effectiveness, and security of human and veterinary drugs,
`vaccines and other biological products for human use, and medical devices. The agency also is
`responsible for the safety and security of our nation’s food supply, cosmetics, dietary
`supplements, products that give off electronic radiation, and for regulating tobacco products.
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`###
`
`Inquiries
`Media:
` Kristin Jarrell (mailto:kristin.jarrell@fda.hhs.gov)
` 301-796-0137
`
`Consumer:
` 888-INFO-FDA
`
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