Administrative Law Judge Dismisses Antitrust Charges Related to Cancer Detection Tests

WASHINGTON — An administrative law judge has dismissed an antitrust complaint brought against DNA sequencing provider Illumina, Inc. related to its proposed $7.1 billion acquisition of GRAIL, Inc., the major developer of a multi-cancer early detection test.

The tests are noninvasive, early detection liquid biopsy tests that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing.

In a complaint filed in March 2021, the Federal Trade Commission alleged Illumina’s acquisition of GRAIL would diminish innovation in the U.S. market for MCED tests. 

These tests could be used to detect up to 50 types of cancer, most of which are not screened for at all today, saving millions of lives around the world. 

GRAIL is one of several competitors racing to develop these liquid biopsy tests, which analyze a sample of a patient’s blood or other fluid through DNA sequencing.

In dismissing the complaint, Chief Administrative Law Judge D. Michael Chappell held that “Complaint Counsel has failed to prove its asserted prima facie case — that Illumina’s post-acquisition ability and incentive to advantage GRAIL to the disadvantage of GRAIL’s alleged rivals is likely to result in a substantial lessening of competition in the relevant market for the research, development, and commercialization of MCED tests.”

Chappell also noted that the FTC staff’s evidence falls far short of proving its factual assertions that “GRAIL’s rivals are poised to imminently launch their products commercially in direct competition with GRAIL.”

Even if the tests in development could be expected to launch earlier than a five-to-seven-year range, the evidence fails to prove the FTC staff’s assertion that the MCED tests under development are “reasonably interchangeable” with GRAIL’s MCED test, known as Galleri, the judge said.

Further, he said Illumina’s status as the only viable supplier of next-generation sequencing instruments appropriate for MCED tests existed before the acquisition –— and therefore Illumina’s asserted abilities to raise prices, withhold supply, or decrease the quality of products or services also existed before the acquisition.

Chappell’s initial decision is subject to review by the full commission on its own motion or at the request of any party, and complaint counsel filed a Notice of Appeal on Sept. 2. 

The initial decision will become the final decision of the commission 30 days after it is served upon the parties unless, prior to that date, complaint counsel perfect their appeal by filing an appeal brief or the commission places the case on its own docket for review.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue.