FTC Orders Illumina To Divest Cancer Test Developer Grail

(RTTNews) - The Federal Trade Commission on Monday ordered Illumina Inc. (ILMN) to divest its acquisition of cancer test developer Grail Inc., saying the deal would stifle competition and innovation.

The FTC issued an Opinion and Order requiring DNA sequencing provider Illumina to divest Grail, which makes a multi-cancer early detection (MCED) test, finding that the deal would stifle competition and innovation in the U.S. market for life-saving cancer tests.

The Opinion reverses an Administrative Law Judge's Initial Decision that dismissed the antitrust charges in a complaint brought by FTC staff.

Meanwhile, Illumina said it it will appeal the FTC's decision. Illumina intends to file a petition for review promptly with a US Court of Appeals and will seek expedited treatment of the appeal. The FTC's order to unwind the acquisition will be automatically stayed pending appeal.

Following the FTC Chief Administrative Law Judge's (ALJ) decision in favor of Illumina in September 2022, Illumina believes that it has a strong case on appeal.

Grail makes non-invasive, early detection liquid biopsy tests that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing.

Grail is one of several competitors racing to develop and commercialize these life-saving liquid biopsy tests. Illumina is the dominant producer of next-generation sequencing (NGS) platforms, which are used to analyze genetic material from the blood samples drawn for MCED tests. These tests could be used to detect multiple types of cancer, most of which are not screened for at all today.

"The Commission found that the acquisition would diminish innovation in the U.S. market for MCED tests while increasing prices and decreasing choice and quality of tests. This is extremely concerning given the importance of swiftly developing effective and affordable tools to detect cancer early," FTC said in a statement.

Illumina said it expects a final decision on an appeal in late 2023 or early 2024. That's also when the company expects a decision on its appeal of a similar order by European Union regulators.

The European Commission last year blocked Illumina's acquisition over similar concerns that it would hurt consumer choice and innovation. Illumina said last month it has challenged the European Commission, arguing the agency lacks jurisdiction to block the merger between the two U.S. companies.