Focus: Cancer researchers question antitrust arguments against Illumina-Grail deal

Pacific Biosciences of California

16/12/2022 12:00

By Deena Beasley and Julie Steenhuysen
       LOS ANGELES/CHICAGO, Dec 16 (Reuters) - U.S. and
European antitrust enforcers want to unwind gene sequencing
leader Illumina Inc's  ILMN.O  purchase of cancer test company
Grail, saying the two would stifle competition in a critical
area of medicine, but some cancer researchers say it's far too
early to make that assessment.
    Illumina is the leading maker of high-speed genomic
sequencing systems that can examine fragments of DNA found in
blood or other samples for use in everything from solving crimes
to drug research. 
    Antitrust regulators argue that Illumina, whose sequencers
are being used by companies, hospitals and research centers,
could unfairly prioritize Grail in the race to create tests for
the early detection of multiple types of cancer. Illumina could
raise prices or withhold the technology competing test
developers need to thrive.
    But Reuters interviews with 13 cancer researchers, genomics
experts and potential competitors to Grail and Illumina show the
field of winners and losers among early detection cancer test
makers is still far from decided, suggesting the $7.1 billion
deal won't strengthen Grail's hand as much as regulators fear.
    In court documents, competition enforcers cite concerns from
Grail rivals about being disadvantaged by the tie-up. 
    Exact Sciences Corp  EXAS.O  and six other companies
testified in the U.S. that they relied on Illumina's system. The
Illumina system is more advanced than others and switching too
costly, they said.
    At the same time, Grail is the only company with a blood
test designed to detect multiple early-stage cancers on the
market, giving it a first-mover advantage with doctors
prescribing the tests. However, it does not have regulatory
approval and likely needs a lot more data to prove it works. 
    "The jury is still out," on which technology will dominate,
said Dr. Sadik Esener, director of the Cancer Early Detection
Advanced Research Center at the OHSU Knight Cancer Institute in
Portland, Oregon. He added it could take as long as 20 years to
show that an early cancer detection test saved lives.    
    The EU has ordered Illumina to sell Grail, a move the
company plans to appeal. 
    "While there is still uncertainty about the exact results of
this innovation race and the future shape of the market for
early cancer detection tests, protecting this current innovation
competition is crucial," an EU Commission spokesperson said.
    The U.S. Federal Trade Commission has lost its case to stop
the deal and is appealing the decision. The FTC declined to
comment. In court documents, the agency said the deal, even in
the early days of competition before a clear commercial market
is established, will diminish innovation.
    "Right now Grail is the only one on the market. In
antitrust, we tend to give outsized importance to the one on the
market," said Michael Carrier, who teaches antitrust law at
Rutgers Law School. Still, he noted "thoughts about their role
being diminished in the future is speculative."
    Esener, who uses gene sequencing machines from Illumina and
Pacific Biosciences of California (PacBio)  PACB.O  for research
looking to detect liver cancer in its earliest stages, noted the
field of early cancer detection is diverse, with about 30
companies working on five different methods of testing for signs
of very early cancer – including the types Grail and its rivals
are focused on.
    If proven to work, early cancer detection tests could help
doctors identify cancer risk in patients long before symptoms or
other indicators develop.
        DIFFERENT APPROACHES    
    Several of the leading contenders take vastly different
approaches to cancer detection and it is not yet clear which
methods will prove most useful or when. Large, lengthy clinical
trials are also needed to show the tests can benefit patients,
experts say.
    “All of the published data to date suggests promise, but
nothing more than that,” said Dr. Ernest Hawk at The University
of Texas MD Anderson Cancer Center.
        Companies that make sequencing systems that compete with
Illumina include Thermo Fisher Scientific Inc  TMO.N , Ultima
Genomics Inc and 10x Genomics.
    Each group pursuing a test uses a different approach.
Grail's Galleri test uses genetic sequencing and artificial
intelligence to scan blood samples for patterns of chemical
changes associated with specific cancers. Delfi Diagnostics Inc
is using machine learning to analyze cancer DNA in the blood and
is focused on early detection of only a handful of common
cancers such as lung cancer. Guardant Health has been working on
a blood test to detect colorectal cancer using a combination of
DNA alterations and other biomarkers. 
    Other cancer test developers don't rely on gene sequencing
at all. Some are working on blood tests to detect different
markers of early cancer, including proteins.
    Until evidence proves that early detection is viable, tests
could come and go, researchers said, with companies selling them
to paying patients while trials are ongoing.
 (Reporting by Deena Beasley in Los Angeles and Julie
Steenhuysen in Chicago; additional reporting by Diane Bartz in
Washington and Foo Yun Chee in Brussels; editing by Caroline
Humer and Chris Sanders)
 ((caroline.humer@thomsonreuters.com;))