Case 1:20-cv-01580-LPS Document 55 Filed 04/21/21 Page 1 of 8 PageID #: 11788
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` IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GUARDANT HEALTH, INC.,
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`Plaintiff,
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`v.
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`FOUNDATION MEDICINE, INC.,
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`Defendant.
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`C.A. No. 20-cv-1580-LPS
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`FILED UNDER SEAL
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`DECLARATION OF JUSTIN ODEGAARD
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`Case 1:20-cv-01580-LPS Document 55 Filed 04/21/21 Page 2 of 8 PageID #: 11789
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`1.
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`I, Justin Odegaard, have personal knowledge of the following facts or believe
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`them to be true based on information provided to me by others and a reasonable investigation. I
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`would testify that the facts in this declaration are true and correct, to the best of my knowledge,
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`if given the opportunity to do so.
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`2.
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`This declaration includes facts known to me at the time I signed this declaration.
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`I reserve the right to supplement or amend this declaration in the future, including through
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`testimony in deposition or at trial.
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`I.
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`Background
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`3.
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`I am the Vice President Clinical Development at Guardant Health Guardant
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`Health, Inc. (“Guardant”). I have been employed by Guardant since March 2016 and have been
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`involved with the development of Guardant’s products since I joined.
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`4.
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`My responsibilities
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`include directing
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`laboratories at Guardant and
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`the
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`development of Guardant’s products for clinical uses, including Guardant360® CDx and
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`Guardant360® LDT.
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`5.
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`I earned a PhD in Immunology and an MD at Stanford University School of
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`Medicine in 2007 and 2009 respectively.
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`6.
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`Before joining Guardant I held positions at Lifecode, Inc, the University of
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`California San Francisco, OneOme, and was an adjunct professor of pathology at Stanford
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`University.
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`II.
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`Guardant360® CDx Test Reports
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`7.
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`Guardant360® CDx is the first Comprehensive Genomic Profiling (CGP) liquid
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`biopsy to receive FDA approval, which was granted on August 7, 2020. It was designed to
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`identify clinically actionable mutations in a patient’s cancer and match them with FDA-approved
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`therapies, or therapies under clinical study for FDA approval. Guardant360® CDx is indicated
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`2
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`Case 1:20-cv-01580-LPS Document 55 Filed 04/21/21 Page 3 of 8 PageID #: 11790
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`to provide tumor mutation profiling for advanced cancer patients with any solid malignant
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`neoplasm.
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`8.
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`When a physician orders a Guardant 360® CDx test, a report is returned. I have
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`attached a set of sample reports as Exhibits A – C that are deidentified (for privacy reasons) but
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`are representative of the information a practitioner would receive upon ordering a Guardant360®
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`CDx test. A Guardant360® CDx report contains both a “professional services” section, which
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`includes a report on alterations in all 74 genes on the panel, in addition to an FDA-approved
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`section, which is limited to 55 genes. The full list of 74 genes is listed in Ex. D
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`(https://guardant360cdx.com/genelist/).
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`9.
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`The first page of the report—the most important to physicians—provides a
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`“Summary of Detected Somatic Alterations, Immunotherapy Biomarkers & Associated
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`Treatment Options.” An example from Exhibit A is below:
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`10.
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`As shown above, each of the Detected Alteration and Biomarkers (from the 74
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`genes) is identified along with the associated FDA-approved therapies. This allows a physician
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`to immediately identify the most relevant therapies that may benefit their patents.
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`3
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`Case 1:20-cv-01580-LPS Document 55 Filed 04/21/21 Page 4 of 8 PageID #: 11791
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`11.
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`In exhibit A, for example, 4 alterations or biomarkers are identified. Three have
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`associated FDA-approved therapies which are all listed and can be prescribed to the patient. This
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`includes Olaparib, also known as Lynparza®, due to the presence of a somatic alteration in the
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`ATM gene. The report also identifies clinical trial availability for each of the detected alterations
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`and biomarkers.
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`12.
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`At the end of the report is the “FDA-approved” section. See e.g., Ex. A at pp. 21-
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`22. This section will only identify the detected biomarkers from among the 55 genes approved
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`as part of the Guardant360® CDx and the companion diagnostic indication. Regardless of
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`whether an alteration or biomarker has a companion diagnostic indication, any detected
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`alteration from the 55 genes will be listed in the “FDA-approved” section with a reference to the
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`first portion of the report (“professional services section”) where corresponding FDA-approved
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`therapies are identified. See e.g., Ex. B at 7. All information from the “FDA-approved” section
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`is included in the earlier portion (the “professional services”) section of the report.
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`13.
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`I understand that FMI has claimed that “[r]emoving access to F1LCDx” “would
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`deprive prescribers of the only comprehensive liquid biopsy option for reporting ATM
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`alterations.” D.I. 38 at 25. This is not true. While only reports of pathogenic germline alterations
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`in ATM and CDK12 are included in the “FDA-approved” portion of the Guardant360® CDx test,
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`somatic alterations are included in Guardant360® CDx professional services section on the first
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`page. See Ex. A at 1 (identifying Lynparza® (olaparib) in association with a somatic ATM
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`alteration). They are also included in the Guardant360® LDT reports discussed below.
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`III. Guardant360® LDT Test Reports
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`14.
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`Guardant360® LDT (Laboratory Developed Test) is an expanded version of the
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`Guardant360® CDx that reports additional alterations and biomarkers, including tumor
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`mutational burden. Like Guardant360® CDx, Guardant360® LDT was designed to identify
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`4
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`Case 1:20-cv-01580-LPS Document 55 Filed 04/21/21 Page 5 of 8 PageID #: 11792
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`clinically actionable mutations in a patient’s cancer and match them with FDA-approved
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`therapies, or therapies under clinical study for FDA approval.
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`15.
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`Like Guardant360® CDx, when a physician orders a Guardant 360® LDT test, a
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`report is returned. I have attached a set of deidentified sample reports as Exhibits E – G that are
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`representative of the information a practitioner would receive upon ordering a Guardant360®
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`LDT test. The reports are nearly identical to the Guardant360 CDx reports except that the “FDA-
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`approved” section is not included at the end.
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`16.
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`I am familiar with FMI’s FoundationOne Liquid CDx and have reviewed the
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`FDA-approved
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`labeling
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`for
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`the
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`product.
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`Ex.
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`H
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`(https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190032C.pdf). Every gene for which
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`alterations are reported by FoundationOne Liquid CDx and has an associated FDA-approved
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`therapy for solid tumors is also interrogated by Guardant360® CDx or Guardant360® LDT, and
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`most are covered by both. See Ex. B at 5; Ex. F at 6.
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`17.
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`I understand that FMI has argued that Guardant should not be able to rely on the
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`GuardantOMNI® panel because it is “prohibitively expensive, and not suitable for clinical use.”
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`This is not true. While the GuardantOMNI® product was originally intended for use by
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`biopharmaceutical customers, Guardant360® LDT uses the same 400+ gene panel used by
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`Guardant’s GuardantOMNI® product. The only difference is that the report generated for
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`Guardant360® LDT includes only those alterations or biomarkers that might be useful to a
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`physician when treating a patient. In other words, it includes those alterations or biomarkers
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`with an FDA-approved therapy. Further, as discussed below, physicians regularly rely on
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`Guardant360® LDT for the treatment of patients. Indeed, Guardant360® LDT currently
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`accounts for over
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` of Guardant360® orders. Thus, it is “suitable for clinical use.”
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`5
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`Case 1:20-cv-01580-LPS Document 55 Filed 04/21/21 Page 6 of 8 PageID #: 11793
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`IV.
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`Physician Use of Guardant360® CDx and LDT Test Reports
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`18.
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`The FDA-approved physician labeling for Guardant360® CDx notes that one of
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`the intended uses is “to provide tumor mutation profiling to be used by qualified health care
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`professionals in accordance with professional guidelines in oncology for cancer patients with
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`any solid malignant neoplasm. The test is for use with patients previously diagnosed with cancer
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`and
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`in conjunction with other
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`laboratory and clinical
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`findings.”
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` Ex.
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`I at 4
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`(https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200010C.pdf). In my experience, ordering
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`physicians utilize Guardant360® CDx and LDT for this purpose and prescribe treatment based
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`upon the detected alterations and biomarkers indicated by the test results. This is not limited to
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`only Tagrisso® or FDA-approved therapies with a CDx indication but includes other FDA-
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`approved therapies like Lynparza®. Indeed, even before Guardant360® CDx received FDA
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`approval, more than 7,000 physicians had ordered Guardant360® to determine the best
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`treatments for more than 100,000 patients.
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`19.
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`I understand that a declaration submitted by FMI argues that due to the lack of
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`companion diagnostic indications, “physicians cannot rely on Guardant360® CDx’s testing
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`results to select patients for treatment with alectinib, gefitinib, erlotinib, olaparib, rucaparib, or
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`alpelisib.” D.I. 36 at 5. I disagree. Physicians can and do regularly rely on Guardant360® CDx
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`test results to prescribe these treatments.
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`20.
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`Attached as Exhibit J is a summary of aggregated claims data from 2014 to 2020
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`showing treatments prescribed to a subset of patients after receiving a Guardant360® test. The
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`summary shows that
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` patients with EGFR Exon 19 deletions or EGFR Exon 21 L858R
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`substitution were prescribed gefitinib, osimertinib, or erlotinib (the corresponding FDA-
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`approved therapies) after Guardant360® tests reported these alterations, and similar data are
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`presented for the remainder of the therapies cited in FMI’s declaration. These data clearly
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`6
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`Case 1:20-cv-01580-LPS Document 55 Filed 04/21/21 Page 7 of 8 PageID #: 11794
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`indicate that in contrast to FMI’s declaration physicians can and do rely on Guardant360® test
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`results to select patients for treatment with these agents or others.
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`21.
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`I know of no medical or scientific reason why an ordering physician would not
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`or could not rely on the information reported by Guardant360® in the professional services
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`section or LDT report when creating a tailored treatment plan. Indeed, in my experience the large
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`majority of all molecular testing for therapy selection in the United States, not just limited to
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`liquid biopsy or Guardant products, is done using LDT tests, not CDx tests.
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`V.
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`Reimbursement and Medicare Coverage
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`22. Medicare reimbursement for Guardant360® and FoundationOne Liquid CDx
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`tests is also indifferent to the differences in CDx indications between the two tests. Attached as
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`exhibit K is the National Coverage Decision (NCD) that applies to both FMI’s test and
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`Guardant360® CDx. While the CDx indication for Guardant360® CDx is for treating non-small
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`cell lung cancer, Guardant (like FMI) receives reimbursement when provided for patients with a
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`wide variety of cancers as both tests have identical FDA approval for tumor profiling. Ex. I at
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`3-4; Ex. H at 1.
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`23.
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`Further, Guardant has obtained a Medicare Administrative Contractor (MAC)
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`Local Coverage Decision (LCD) that covers both the Guardant360® CDx and LDT tests. The
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`LCD is attached as exhibit L. Like the NCD, the LCD does not depend on CDx indications or
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`FDA approval at all when considering reimbursement and covers a wide variety of cancers.
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`Further, the LCD is not limited to patients in any one geographical area of the United States, but
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`rather covers all tests performed on Medicare patients by Guardant.
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`I declare under the penalty of perjury under the laws of the United States of America that
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`the foregoing is true and correct.
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`7
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`Case 1:20-cv-01580-LPS Document 55 Filed 04/21/21 Page 8 of 8 PageID #: 11795
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`Executed on March 29, 2021 at Woodside, California.
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`Justin Odegaard
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`8
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