Case: 23-60167 Document: 136 Page: 1 Date Filed: 06/12/2023
`
`No. 23-60167
`
`IN THE
`United States Court of Appeals
`FOR THE FIFTH CIRCUIT
`ILLUMINA, INC. AND GRAIL, INC.,
`
`
`
`Petitioners-Appellants,
`
`
`
`V.
`FEDERAL TRADE COMMISSION,
`
`
`Respondent-Appellee.
`
`Petition for Review of an Order
`of the Federal Trade Commission
`
`
`
`
`
`
`
`
`
`
`
`
`
`BRIEF OF DR. GEORGE CHARAMES AND DR. ERIC DUNCAVAGE
`AS AMICI CURIAE SUPPORTING PETITIONERS AND REVERSAL
`
`
`Jeffrey A. Lamken
` Counsel of Record
`MOLOLAMKEN LLP
`The Watergate, Suite 500
`600 New Hampshire Avenue, N.W.
`Washington, D.C. 20037
`(202) 556-2000 (telephone)
`(202) 556-2001 (facsimile)
`jlamken@mololamken.com
`
`Sara E. Margolis
`MOLOLAMKEN LLP
`430 Park Avenue
`New York, NY 10022
`(212) 607-8160 (telephone)
`(212) 607-8161 (facsimile)
`
`Matthew J. Fisher
`MOLOLAMKEN LLP
`300 N. LaSalle Street, Suite 5350
`Chicago, IL 60654
`(312) 450-6700 (telephone)
`(312) 450-6701 (facsimile)
`
`
`Counsel for Amici Curiae
` (
`
`

`

`Case: 23-60167 Document: 136 Page: 2 Date Filed: 06/12/2023
`
`CERTIFICATE OF INTERESTED PERSONS
`Illumina Inc. v. Federal Trade Commission, No. 23-60167
`
`The undersigned counsel of record certifies that the following listed persons
`
`and entities as described in the fourth sentence of Rule 28.2.1 have an interest in
`
`the outcome of this case. These representations are made in order that the judges
`
`of this Court may evaluate possible disqualification or recusal.
`
`Petitioners
`
`Counsel
`
`Illumina, Inc.
`
`Grail, Inc.
`
`David R. Marriott
`Christine A. Varney
`Antony L. Ryan
`Sharonmoyee Goswami
`Michael J. Zaken
`Jesse M. Weiss
`Benjamin A. Atlas
`CRAVATH, SWAINE & MOORE LLP
`825 Eighth Avenue
`Worldwide Plaza
`New York, NY 10019
`Telephone: (212) 474-1000
`
`Gregory G. Garre
`Michael G. Egge
`Marguerite M. Sullivan
`Anna M. Rathbun
`David L. Johnson
`LATHAM & WATKINS LLP
`555 Eleventh Street, N.W.
`Suite 1000
`Washington, D.C. 20004
`Telephone: (202) 637-2200
`
`
`
`
`i
`
`

`

`Case: 23-60167 Document: 136 Page: 3 Date Filed: 06/12/2023
`
`Alfred C. Pfeiffer
`LATHAM & WATKINS LLP
`505 Montgomery Street
`Suite 2000
`San Francisco, CA 94111-6538
`Telephone: (415) 391-0600
`
`
`Respondent
`
`Counsel
`
`
`
`Federal Trade Commission
`
`Matthew M. Hoffman
`FEDERAL TRADE COMMISSION
`600 Pennsylvania Ave., N.W.
`Washington, D.C. 20580
`Telephone: (202) 326-3097
`
`
`
`
`Amicus Curiae
`
`Counsel
`
`Washington Legal Foundation
`
`American Hospital Association
`
`Americans for Prosperity Foundation
`
`John M. Masslon II
`Cory L. Andrews
`WASHINGTON LEGAL FOUNDATION
`209 Massachusetts Ave., N.W.
`Washington, D.C. 20036
`Telephone: (202) 588-0302
`
`Chad Golder
`Melinda Reid Hatton
`AMERICAN HOSPITAL ASSOCIATION
`800 10th Street, N.W.
`Two CityCenter, Suite 400
`Washington, D.C. 20001
`Telephone: (202) 626-4624
`
`Michael Pepson
`AMERICANS FOR PROSPERITY
`FOUNDATION
`1310 N. Courthouse Road, Suite 700
`Arlington, VA 22201
`
`ii
`
`

`

`Case: 23-60167 Document: 136 Page: 4 Date Filed: 06/12/2023
`
`U.S. Chamber of Commerce
`
`34 Members of Congress
`
`(See Appendix to Brief of 34 Members
`of Congress as Amici Curiae in Support
`of Petitioners, Doc. No. 119)
`
`
`Telephone: (571) 329-4529
`
`Tyler S. Badgley
`Jordan L. Von Bokern
`U.S. CHAMBER LITIGATION CENTER
`1615 H Street, N.W.
`Washington, D.C. 20062
`Telephone: (202) 463-5337
`
`Jeffrey M. Harris
`Frank H. Chang
`CONSOVOY MCCARTHY PLLC
`1600 Wilson Boulevard, Suite 700
`Arlington, VA 22201
`Telephone: (703) 243-9423
`
`Steven Cernak
`BONA LAW PC
`28175 Haggerty Road
`Novi, MI 48377
`Telephone: (248) 994-2221
`
`Aaron Gott
`BONA LAW PC
`331 2nd Avenue S., #420
`Minneapolis, MN 55401
`Telephone: (612) 284-5001
`
`Luke Hasskamp
`Luis Blanquez
`BONA LAW PC
`4275 Executive Square, Suite 200
`La Jolla, CA 92037
`Telephone: (858) 964-4589
`
`Patrick Pascarella
`BONA LAW PC
`100 Crescent Court, #700-3425
`Dallas, TX 75201
`Telephone: (469) 296-7716
`
`iii
`
`

`

`Case: 23-60167 Document: 136 Page: 5 Date Filed: 06/12/2023
`
`Brianna L. Alderman
`Roger D. Blair
`
`Dr. George Charames
`Dr. Eric Duncavage
`
`Kathleen R. Hartnett
`COOLEY LLP
`3 Embarcadero Center, 20th Floor
`San Francisco, CA 94111
`Telephone: (415) 693-2000
`
`Adam S. Gershenson
`COOLEY LLP
`500 Boylston Street, 14th Floor
`Boston, MA 02116
`Telephone: (617) 937-2300
`
`Kathy O’Neill
`Ethan Glass
`COOLEY LLP
`1299 Pennsylvania Avenue, N.W.
`Suite 700
`Washington, D.C. 20004
`Telephone: (202) 842-7800
`
`Jeffrey A. Lamken
`MOLOLAMKEN LLP
`The Watergate, Suite 500
`600 New Hampshire Avenue, N.W.
`Washington, D.C. 20037
`(202) 556-2000 (telephone)
`(202) 556-2001 (facsimile)
`
`Sara E. Margolis
`MOLOLAMKEN LLP
`430 Park Avenue, Floor 6
`New York, NY 10022
`(212) 607-8160 (telephone)
`(212) 607-8161 (facsimile)
`
`Matthew J. Fisher
`MOLOLAMKEN LLP
`300 N. LaSalle Street, Suite 5350
`Chicago, IL 60654
`(312) 450-6700 (telephone)
`
`iv
`
`

`

`Case: 23-60167 Document: 136 Page: 6 Date Filed: 06/12/2023
`
`
`
`
`(312) 450-6701 (facsimile)
`
`
`/s/ Jeffrey A. Lamken
`Jeffrey A. Lamken
`MOLOLAMKEN LLP
`The Watergate, Suite 500
`600 New Hampshire Avenue, N.W.
`Washington, D.C. 20037
`(202) 556-2000 (telephone)
`(202) 556-2001 (facsimile)
`jlamken@mololamken.com
`
`Attorney of record for Dr. George
`Charames and Dr. Eric Duncavage
`
`v
`
`

`

`Case: 23-60167 Document: 136 Page: 7 Date Filed: 06/12/2023
`
`TABLE OF CONTENTS
`
` Page
`INTEREST OF AMICI CURIAE ............................................................................... 1 
`INTRODUCTION ..................................................................................................... 2 
`ARGUMENT ............................................................................................................. 5 
`I. 
`The Commission’s Decision Threatens the Availability of a
`Lifesaving Screening Tool ............................................................................... 5 
`A. 
`The Galleri Test Is a Revolutionary Screening Tool with the
`Potential To Dramatically Reduce Suffering and Mortality ................. 5 
`The Galleri Test Resulted from Years of Costly Research and
`Development ...................................................................................... 10 
`The Acquisition of Grail by Illumina Is Necessary To
`Accelerate Galleri’s Widespread Adoption ........................................ 13 
`The Commission’s Decision Prioritizes Hypothetical Competitors
`over Human Lives .......................................................................................... 14 
`CONCLUSION ........................................................................................................ 18
`
`B. 
`
`C. 
`
`II. 
`
`vi
`
`

`

`Case: 23-60167 Document: 136 Page: 8 Date Filed: 06/12/2023
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Aleksandr Ivanov, Barriers to the Introduction of New Medical
`Diagnostic Tests, 44 Lab. Med. e132 (2013) ..................................................... 11
`Allan Hackshaw et al., Estimating the Population Health Impact of a
`Multi-Cancer Early Detection Genomic Blood Test To
`Complement Existing Screening in the US and UK,
`125 Br. J. Cancer 1432 (2021), https://doi.org/10.1038/s41416-
`021-01498-4 .......................................................................................................... 5
`American Cancer Society, Cancer Statistics Center: 2023 Estimates,
`https://cancerstatisticscenter.cancer.org/#!/ .......................................................... 2
`Aroon D. Hingorani et al., Improving the Odds of Drug Development
`Success Through Human Genomics: Modelling Study,
`9 Sci. Rep. 18911 (Dec. 2019) ............................................................................ 11
`BBC, Multi-Cancer Blood Test Shows Real Promise in NHS Study
`(June 2, 2023), https://www.bbc.com/news/health-65775159 ..................... 14, 15
`Bloomberg, Grail and National Health Service (NHS) England
`Complete Enrollment of 140,000 Participants in Largest Study of
`Multi-Cancer (July 18, 2022), https://www.bloomberg.com/press-
`releases/2022-07-18/grail-and-national-health-service-nhs-
`england-complete-enrollment-of-140-000-participants-in-largest-
`study-of-multi-cancer .......................................................................................... 15
`Candace Westgate et al., Poster: Early Real-World Experience with a
`Multi-Cancer Early Detection Test, American Society of Clinical
`Oncology (June 2023), https://grail.com/wp-content/uploads
`/2023/06/Westgate_ASCO-2023_Clinical-
`Surveillance_Poster_FINAL.pdf ...................................................... 7, 8, 9, 14, 15
`Centers for Disease Control and Prevention, Colorectal Cancer
`Screening Tests (Feb. 23, 2023), https://www.cdc.gov/cancer/
`colorectal/basic_info/screening/tests.htm ............................................................. 6
`David Crosby et al., Early Detection of Cancer, Science, Mar. 2022,
`https://www.science.org/doi/epdf/10.1126/science.aay9040 ............................... 7
`
`vii
`
`

`

`Case: 23-60167 Document: 136 Page: 9 Date Filed: 06/12/2023
`
`Duxin Sun et al., Why 90% of Clinical Drug Development Fails and
`How To Improve It?, 12 Acta Pharmaceutica Sinica B 3049 (2022) ................. 11
`Harold J. Galena, Complications Occurring from Diagnostic
`Venipuncture, 34 J. Fam. Pract. 582 (1992) ......................................................... 9
`Jung Yun Park et al., The Outcomes of Management for Colonoscopic
`Perforation: A 12-Year Experience at a Single Institute,
`32 Annals of Coloproctology 175 (2016) ............................................................. 7
`Martha S. Linet et al., Cancer Risks Associated with External
`Radiation from Diagnostic Imaging Procedures,
`62 CA Cancer J. Clin. 75 (2012) .................................................................... 6, 17
`Meg Farris, Test Can Detect 50 Types of Cancer Before You Have
`Symptoms and You Can Get It Locally, WWL-TV (June 7, 2022),
`https://www.wwltv.com/article/news/health/galleri-blood-test-
`cancer-screening-ochsner-trial/289-17d296c9-ad16-4531-b7d5-
`6e533ea0ebd5 ..................................................................................................... 15
`Natera, Inc., FQ4 2022 Earnings Call (Feb. 28, 2023),
`https://s201.q4cdn.com/354493536/files/doc_financials/2022/q4/N
`atera_Q4_2023_Transcript.pdf ........................................................................... 16
`Patricia A. Deverka et al., Multicancer Screening Tests: Anticipating
`and Addressing Considerations for Payer Coverage and Patient
`Access, 41 Health Affairs 383 (2022) ........................................................... 5, 8, 9
`Tiago Brito-Rocha et al., Shifting the Cancer Screening Paradigm:
`The Rising Potential of Blood-Based Multi-Cancer Early Detection
`Tests, 12 Cells 935 (2023) ............................................................................ 6, 7, 8
`Timothy P. Hanna et al., Mortality Due to Cancer Treatment Delay:
`Systematic Review and Meta-Analysis, BMJ (2020), http://dx.doi.
`org/10.1136/bmj.m4087 ........................................................................................ 6
`Varut Lohsiriwat et al., What Are the Risk Factors of Colonoscopic
`Perforation?, 9 BMC Gastroenterology 71 (2009)
`http://www.biomedcentral.com/1471-230X/9/71 ................................................. 7
`
`viii
`
`

`

`Case: 23-60167 Document: 136 Page: 10 Date Filed: 06/12/2023
`
`World Health Organization, Early Cancer Diagnosis Saves Lives,
`Cuts Treatment Costs (Feb. 3, 2017), https://www.who.int/news/
`item/03-02-2017-early-cancer-diagnosis-saves-lives-cuts-
`treatment-costs ...................................................................................................... 6
`
`
`
`ix
`
`

`

`Case: 23-60167 Document: 136 Page: 11 Date Filed: 06/12/2023
`
`INTEREST OF AMICI CURIAE1
`Amici curiae are leading medical professionals who have extensive exper-
`
`ience researching and developing cancer tests and diagnostic tools. As a result, amici
`
`have a strong personal and professional interest in ensuring the development and
`
`widespread availability of effective early-stage cancer-screening tools that can save
`
`lives and reduce suffering.
`
`Dr. George Charames is Director and Head of the Advanced Molecular
`
`Diagnostics Laboratory in the Department of Pathology and Lab Medicine at Mount
`
`Sinai Hospital in Toronto, Canada. He is also an Associate Professor in the Depart-
`
`ment of Laboratory Medicine and Pathobiology, Temerty Faculty of Medicine at the
`
`University of Toronto. Dr. Charames received his MSc and PhD from the Depart-
`
`ment of Laboratory Medicine and Pathobiology at the University of Toronto.
`
`Dr. Eric Duncavage is a Professor of Pathology and Immunology at
`
`Washington University School of Medicine in St. Louis where he leads the Section
`
`of Molecular Oncology. Dr. Duncavage is Board Certified in Anatomic and Clinical
`
`Pathology, Molecular Pathology, Hematopathology, and Clinical Informatics. He
`
`
`1 No counsel for either party authored this brief in whole or in part, no party or party’s
`counsel contributed money intended to fund the preparation or submission of the
`brief, and no one other than amici contributed money intended to fund the
`preparation or submission of the brief. All parties have consented to the filing of
`this brief.
`
`1
`
`

`

`Case: 23-60167 Document: 136 Page: 12 Date Filed: 06/12/2023
`
`received his medical degree from the University of Tennessee College of Medicine
`
`in Memphis, Tennessee.
`
`Amici sign this brief in their individual capacities and not as an employee or
`
`agent of any institution. The positions taken in this brief are those of amici alone
`
`and should not be attributed to any institution with which amici are or have been
`
`affiliated.
`
`INTRODUCTION
`Cancer exacts a devastating toll on Americans. Currently the second-leading
`
`cause of death in this country, cancer will soon be the leading cause of death,
`
`overtaking any other cause of mortality. In 2023, two million people will be
`
`diagnosed with cancer for the first time; in that year alone, 600,000 will die of
`
`cancer.2 Cancer does not merely inflict incalculable pain and suffering on its
`
`victims. It also leaves families shattered and friends grieving in its wake. As
`
`medical professionals, we see—first-hand—cancer’s destructive toll.
`
`Innovations like the one at issue in this case, however, provide reason for
`
`optimism. During the past decade, medical professionals have made progress in the
`
`battle against cancer. Improvements related to cancer screening and early detection
`
`have begun to show tremendous potential. When cancer is detected in its early
`
`
`2 See American Cancer Society, Cancer Statistics Center: 2023 Estimates,
`https://cancerstatisticscenter.cancer.org/#!/.
`
`2
`
`

`

`Case: 23-60167 Document: 136 Page: 13 Date Filed: 06/12/2023
`
`stages, it is more likely that the cancerous cells can be excised completely or treated
`
`through radiation or medication. But if the cancer is not detected until it has spread
`
`throughout the body or mutated, treatment is far less likely to lead to remission.
`
`Many cancers diagnosed in their late stages are more likely to be fatal. Early
`
`detection can save lives.
`
`To significantly improve public health, early-stage detection must be
`
`accessible and avoid being unduly invasive or creating significant health risks. Over
`
`one-third of patients resist invasive screening techniques, such as colonoscopy, due
`
`to discomfort and risk of complications. Further, even non-invasive cancer screen-
`
`ing methods, such as mammography, carry patient risks because (for example) they
`
`expose patients to radiation. Finally, effective cancer screening exists for only a
`
`small fraction of cancer types; for the majority of cancer types there are no effective
`
`cancer-screening programs.
`
`Grail and its proprietary Galleri test promise an answer to those concerns.
`
`Galleri is a multi-cancer early detection (“MCED”) test, aimed at detecting whether
`
`a patient has cancer even before the patient starts showing symptoms. Galleri is the
`
`first—and only—blood-based MCED test available to patients for cancer detection.
`
`Galleri screens for over 50 different types of cancers, including many for which there
`
`is no standard screening procedure. And the Galleri test can reveal the cancer’s
`
`tissue of origin (i.e., where the cancer is located in the body), which allows more
`
`3
`
`

`

`Case: 23-60167 Document: 136 Page: 14 Date Filed: 06/12/2023
`
`targeted follow-up screening, diagnosis, and treatment. Galleri has already demon-
`
`strated its potential as a lifesaving screening test. And it does that without the need
`
`for surgical procedures or x-rays. Detection is performed by drawing and examining
`
`a small quantity of the patient’s blood, a standard process to which all of us have
`
`become accustomed.
`
`But Galleri is not yet widely available. Significant additional investment is
`
`needed to secure FDA approval and make Galleri accessible to patients. By
`
`prohibiting Illumina from acquiring Grail, the Federal Trade Commission has
`
`delayed—and potentially prevented—that investment, jeopardizing Galleri’s future.
`
`The Commission based its decision, in part, on concerns about hypothetical future
`
`competitors in the MCED market. But those competitors are nowhere near
`
`commercializing an MCED assay that would help save patient lives by screening for
`
`dozens of different cancers with a single test. The Commission’s decision prioritizes
`
`hypothetical competition that does not yet exist over lifesaving innovation. If
`
`allowed to stand, the Commission’s decision will harm patients. In this case,
`
`competition to develop and commercialize lifesaving technologies has yielded a
`
`revolutionary test. Concerns about hypothetical later-arriving technologies compe-
`
`ting on price should not be allowed to delay or to deprive the public of the benefits
`
`of a revolutionary technology that, with Illumina’s assistance, has the potential for
`
`widespread adoption.
`
`4
`
`

`

`Case: 23-60167 Document: 136 Page: 15 Date Filed: 06/12/2023
`
`I.
`
`ARGUMENT
`THE COMMISSION’S DECISION THREATENS THE AVAILABILITY OF A
`LIFESAVING SCREENING TOOL
`A. The Galleri Test Is a Revolutionary Screening Tool with the
`Potential To Dramatically Reduce Suffering and Mortality
`Despite the importance of early detection, most cancer-screening tools
`
`available today suffer from serious deficiencies. Existing procedures are relatively
`
`narrow in scope: They can detect only a handful of cancers, such as breast, cervical,
`
`colorectal, lung, and prostate cancers.3 But those cancers account only for approxi-
`
`mately 30 percent of cancer-related deaths.4 For the vast majority of cancers, there
`
`are no standard screening options at all.5
`
`As a result, many cancers can go undetected until the patient is symptomatic
`
`and the cancer has grown or spread to other parts of the body.6 By that time, the
`
`
`3 Allan Hackshaw et al., Estimating the Population Health Impact of a Multi-Cancer
`Early Detection Genomic Blood Test To Complement Existing Screening in the US
`and UK, 125 Br. J. Cancer 1432, 1432 (2021), https://doi.org/10.1038/s41416-021-
`01498-4; see also Initial Decision of the Administrative Law Judge (“Initial
`Decision”) ¶69.
`4 See Hackshaw, supra note 3, at 1432; see also Trial Transcript (“Trial Tr.”) 3619:7-
`21.
`5 Currently, in the United States, there are “screening recommendations for only five
`cancers (breast, colorectal, cervical, lung, and prostate).” Patricia A. Deverka et al.,
`Multicancer Screening Tests: Anticipating and Addressing Considerations for Payer
`Coverage and Patient Access, 41 Health Affairs 383, 383 (2022). By contrast,
`“[t]here are no standard screening options for the majority of cancers today.” Initial
`Decision ¶68.
`6 Cancer’s “high mortality rate” is “mostly due to late detection, finding cancer when
`it has already progressed and metastasized, which significantly reduces effective
`
`5
`
`

`

`Case: 23-60167 Document: 136 Page: 16 Date Filed: 06/12/2023
`
`disease can become difficult—if not impossible—to cure.7 Even apart from
`
`concerns about patient mortality rates, patient suffering increases as well. And as
`
`patients suffer, so do their families and friends.
`
`The few standard screening tools in use today have serious drawbacks. For
`
`example, mammograms can be used to screen for breast cancer. But the required x-
`
`rays are correlated with increased risk of cancer, reducing the net public health
`
`benefit of regular screenings.8 Regular colonoscopies are recommended for certain
`
`groups for early detection of colon cancer.9 But colonoscopies carry the risk of
`
`adverse health consequences, including the potential for perforation of the bowel
`
`
`treatment options.” Tiago Brito-Rocha et al., Shifting the Cancer Screening
`Paradigm: The Rising Potential of Blood-Based Multi-Cancer Early Detection
`Tests, 12 Cells 935, 935 (2023); see Initial Decision ¶¶78-80 (“Most cancers are
`discovered after they have grown and spread in a person’s body.”).
`7 Brito-Rocha, supra note 6, at 935; David Crosby et al., Early Detection of Cancer,
`Science, Mar. 2022, at 1, https://www.science.org/doi/epdf/10.1126/science.
`aay9040 (“When cancer is detected at the earliest stages, treatment is more effective
`and survival drastically improves.”); Timothy P. Hanna et al., Mortality Due to
`Cancer Treatment Delay: Systematic Review and Meta-Analysis, BMJ, at 4-5
`(2020), http://dx.doi.org/10.1136/bmj.m4087; World Health Organization, Early
`Cancer Diagnosis Saves Lives, Cuts Treatment Costs (Feb. 3, 2017), https://
`www.who.int/news/item/03-02-2017-early-cancer-diagnosis-saves-lives-cuts-
`treatment-costs; see also Initial Decision ¶¶81-85.
`8 Martha S. Linet et al., Cancer Risks Associated with External Radiation from
`Diagnostic Imaging Procedures, 62 CA Cancer J. Clin. 75, 76 (2012) (“From 1956
`to the present, epidemiologic studies have also linked diagnostic x-rays with cancer
`increases in patients.”).
`9 Centers for Disease Control and Prevention, Colorectal Cancer Screening
`Tests (Feb. 23, 2023), https://www.cdc.gov/cancer/colorectal/basic_info/screening/
`tests.htm.
`
`6
`
`

`

`Case: 23-60167 Document: 136 Page: 17 Date Filed: 06/12/2023
`
`during the procedure.10 And the highly invasive nature of some procedures dis-
`
`courages patients from seeking them out.11
`
`To overcome those obstacles, Grail set out to develop a blood-based multi-
`
`cancer early detection (“MCED”) test. Grail’s Galleri test can identify multiple
`
`cancer types from a single blood sample. Galleri leapfrogs existing screening
`
`methods in at least three important ways.
`
`First, Galleri can detect cancers that evade current screening procedures, such
`
`as cancer of the pancreas, ovary, kidney, or liver.12 Galleri is thus an enormous
`
`improvement over existing technologies, which often fail to detect those types of
`
`
`10 Varut Lohsiriwat et al., What Are the Risk Factors of Colonoscopic Perforation?,
`9 BMC Gastroenterology 71, 71
`(2009), http://www.biomedcentral.com
`/1471-230X/9/71 (“[E]ndoscopic perforation of the colon”—one “of the most
`serious complications of colonoscopy”—is “reported as between 0.03% and
`0.7%.”); Jung Yun Park et al., The Outcomes of Management for Colonoscopic
`Perforation: A 12-Year Experience at a Single Institute, 32 Annals of
`Coloproctology 175, 175 (2016) (“Although colonoscopy is a safe procedure, lethal
`complications such as perforation and bleeding may occur during the procedure.”).
`11 See, e.g., Brito-Rocha, supra note 6, at 936 (recognizing that because a colon-
`oscopy “is a rather invasive and uncomfortable procedure, requiring prior
`preparation,” there is “low patient compliance”); id. (noting that existing screening
`procedures have “several drawbacks, leading to low patient compliance”).
`12 See Candace Westgate et al., Poster: Early Real-World Experience with a Multi-
`Cancer Early Detection Test, American Society of Clinical Oncology (June 2023),
`https://grail.com/wp-content/uploads/2023/06/Westgate_ASCO-2023_Clinical-
`Surveillance_Poster_FINAL.pdf; see also Trial Tr. 4000:15-17; Initial Decision
`¶245 (citing results of PATHFINDER clinical study); Trial Tr. 3789:25-3796:9.
`
`7
`
`

`

`Case: 23-60167 Document: 136 Page: 18 Date Filed: 06/12/2023
`
`cancers until they have grown or spread throughout the body (and have become more
`
`difficult to cure).13
`
`Second, Galleri has the potential to accurately detect the presence of a wide
`
`variety of cancer types with a single test.14 Clinical trials have shown that Galleri
`
`can detect over 50 different types of cancer.15 That improves upon existing
`
`screening methods, which aim to detect one type of cancer in a single organ.16
`
`Third, Galleri is minimally invasive. The Galleri test requires only a blood
`
`draw, a common medical procedure that is well tolerated and already conducted at
`
`
`13 See Brito-Rocha, supra note 6, at 936 (opining that MCED tests “have the capacity
`to detect cancer even when symptoms are not present or tumor masses are not
`detectable by imaging techniques”); Deverka, supra note 5, at 384 (“Because
`multicancer early detection screening tests can identify signals from a variety of
`potentially lethal cancers that currently have no recommended screening tests, the
`cancer detection rate could increase significantly for cancers such as pancreatic,
`liver, and ovarian cancers.”); see also Trial Tr. 3781:16-24.
`14 See Westgate, supra note 12 (showing Galleri’s ability to simultaneously screen
`for several types of cancer).
`15 The “performance characteristics” of Galleri “indicate” that it would detect 50
`types of cancer in a sufficiently large interventional trial. See Trial Tr. 3794:3-24.
`While Galleri has not yet been shown clinically to detect all of those 50 types of
`cancer, that is due to the size of the clinical trial sizes that would be required.
`Because of the relatively low incidence of certain cancer types, finding evidence for
`“all 50 cancers” would require trials involving “hundreds of thousands of people.”
`See id. at 3298:12-13.
`16 See Deverka, supra note 5, at 383 (“[S]creening for evidence of diverse common
`and rare cancers in one blood test . . . will improve screening efficiencies over
`individual, organ-specific tests.”).
`
`8
`
`

`

`Case: 23-60167 Document: 136 Page: 19 Date Filed: 06/12/2023
`
`many annual physicals.17 Because the procedure is familiar and non-invasive, many
`
`more patients would proactively seek or tolerate early screening.18 Drawing blood,
`
`moreover, is not associated with significant health risks.19 The health risks involved
`
`in screening through Galleri—unlike most other techniques—are de minimis.
`
`“[T]he ability to add a simple blood draw to detect multiple cancers noninvasively”
`
`thus “would represent a major public health advance.”20
`
`Galleri also has an enormous advantage even over most other MCEDs
`
`reportedly under development. Even if those other tests become available to the
`
`public—an uncertain result that is years away at best—those tests would only
`
`identify the likelihood that cancer exists somewhere in the body. Positive results
`
`will mean that patients must undergo still more procedures to try to determine the
`
`cancer’s location within the body. Even though Galleri detects cancer through a
`
`blood test, it also provides information about the cancer’s origins. Over 90 percent
`
`of the time, the Galleri test can accurately determine not only the presence of cancer,
`
`but also where the cancerous cells are localized in the body.21
`
`
`17 See generally Harold J. Galena, Complications Occurring from Diagnostic
`Venipuncture, 34 J. Fam. Pract. 582, 583 (May 1992).
`18 See Deverka, supra note 5, at 386 (highlighting “the ease of use of a single blood
`test for multiple cancers”).
`19 Galena, supra note 17, at 583 (noting venipuncture is “reasonably safe” and
`“results in few complications”).
`20 Deverka, supra note 5, at 384.
`21 See Westgate, supra note 12 (91% “prediction accuracy” of cancer-signal origin).
`
`9
`
`

`

`Case: 23-60167 Document: 136 Page: 20 Date Filed: 06/12/2023
`
`Those results are remarkable—potentially revolutionary. The vital informa-
`
`tion derived from the Galleri test can inform doctors and patients about whether and
`
`how to follow-up with additional screening, diagnosis, and treatment. Developing a
`
`minimally invasive broad-spectrum test that does not merely detect but also
`
`pinpoints the cancer’s location—one that also has the potential to screen for dozens
`
`of potential cancer types—has long been considered the Holy Grail of cancer-
`
`detection research. Grail’s Galleri test holds enormous promise for allowing doctors
`
`to detect cancers earlier and ensuring patients will get treatment sooner. Thousands
`
`of lives could be saved and incalculable suffering avoided.
`
`B.
`
`The Galleri Test Resulted from Years of Costly Research and
`Development
`The Galleri test relies on breakthrough proprietary developments in DNA
`
`screening that allow practitioners to detect and identify the origin of dozens of
`
`cancers. But developing Galleri was not easy. It did not merely require game-
`
`changing insights. It also required time- and resource-intensive efforts that are a
`
`prerequisite to developing an accurate blood-based MCED test.
`
`First, test developers must undertake sample collection, research, and
`
`biomarker discovery. This requires collecting blood samples from thousands, if not
`
`tens of thousands, of people in order to identify which biomarkers can best predict
`
`whether an individual has cancer. The biomarkers must have the requisite sensitivity
`
`and specificity to detect both the presence of cancer and the tissue from which the
`
`10
`
`

`

`Case: 23-60167 Document: 136 Page: 21 Date Filed: 06/12/2023
`
`cancer originated. That research and discovery stage can take several years, if not
`
`longer. After selecting the appropriate biomarkers to use, the developer focuses on
`
`optimizing test performance, cost, and quality control. Finally, developers must
`
`clinically validate the test—through expensive, multi-year, large-scale studies on
`
`patients—to ensure that it can effectively detect cancer.22 This final step alone could
`
`take five to seven years, even if the clinical studies succeed.
`
`Significantly, a newly developed test could fail at any one of these steps.23
`
`New drugs, for example, fail to make it to market more than 95% of the time.24 The
`
`test’s designer thus pumps extraordinary resources into research and development
`
`without knowing if the test will work, gain regulatory approval, or achieve
`
`commercial success.
`
`
`22 See also Initial Decision ¶186 (“MCED tests will require multi-year, large-scale
`clinical studies to receive FDA approval.”).
`23 See generally Aleksandr Ivanov, Barriers to the Introduction of New Medical
`Diagnostic Tests, 44 Lab. Med. e132 (2013) (describing financial and regulatory
`hurdles to the development and adoption of new medical diagnostic tests).
`24 See Aroon D. Hingorani et al., Improving the Odds of Drug Development Success
`Through Human Genomics: Modelling Study, 9 Sci. Rep. 18911 (2019),
`https://doi.org/10.1038/s41598-019-54849-w (noting overall drug failure rate of
`96%, dropping to 90% for drugs that advance to clinical development); Duxin Sun
`et al., Why 90% of Clinical Drug Development Fails and How To Improve It?, 12
`Acta Pharmaceutica Sinica B 3049, 3050 (2022) (noting that nine of ten drug
`candidates entering clinical studies fail); id. (“Drug discovery and development is a
`long, costly, and high-risk process that takes over 10-15 years with an average cost
`of over $1-2 billion for each new drug to be approved for clinical use.”).
`
`11
`
`

`

`Case: 23-60167 Document: 136 Page: 22 Date Filed: 06/12/2023
`
`In light of these challenges, it is unsurprising that, to date, only one MCED
`
`test—the Galleri test—has made it from proof-of-concept to actual use in practice.
`
`Achieving those breakthroughs required a tremendous investment of money and
`
`labor: It took over six years and inordinate investments to commercialize Galleri
`
`even on a limited basis.
`
`Despite Grail’s investment, Galleri has not yet achieved its full potential.
`
`Galle