US trade panel probes melanoma test imports over false advertising

The U.S. International Trade Commission (ITC) has instituted a Section 337 investigation into certain melanoma predictive and prognostic tests and components, following a complaint alleging unfair competition through false and misleading advertising. The probe, docketed as Investigation No. 337-TA-1519, was ordered on August 25, 2026, and published in the Federal Register of August 27, 2026.

The complaint was filed on July 10, 2026, on behalf of Castle Biosciences, Inc. of Friendswood, Texas, under section 337 of the Tariff Act of 1930, as amended. The complainant alleges that the importation or sale of the accused products violates subsection (a)(1)(A) of section 337, with the threat or effect of destroying or substantially injuring a U.S. industry.

Scope of the investigation

The investigation covers “melanoma predictive and prognostic CP-GEP tests and related components used in connection with such tests.” The ITC’s plain-language description of the accused products defines the scope of the proceeding.

• The complainant is Castle Biosciences, Inc., 1500 West Parkwood Ave., Suite 400, Friendswood, TX 77546.
• The respondents named in the notice are SkylineDx Holding B.V. (Rotterdam, Netherlands), SkylineDx USA, Inc. (San Diego, California), Qiagen GmbH (Hilden, Germany) and QIAGEN LLC (Germantown, Maryland).
• The Office of Unfair Import Investigations of the ITC is also a party to the proceeding.

Possible remedies and procedure

The complainant has asked the Commission to institute the investigation and, after the proceeding, to issue a limited exclusion order and cease-and-desist orders. Under the Commission’s rules, the presiding administrative law judge will take evidence and hear arguments on the public-interest factors set out in 19 U.S.C. 1337(d)(1), (f)(1) and (g)(1).

Named respondents must submit responses to the complaint and the notice of investigation in accordance with section 210.13 of the Commission’s Rules of Practice and Procedure (19 CFR 210.13). The Chief Administrative Law Judge will designate the presiding judge for the case.

The authority for the investigation is found in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in section 210.10 of the Commission’s rules (19 CFR 210.10). The notice was issued by Lisa Barton, Secretary to the Commission, and the contact for further information is Pathenia M. Proctor of the Office of Unfair Import Investigations.

What it means for importers

A Section 337 investigation can culminate in an exclusion order barring the importation of the accused products into the United States, a cease-and-desist order, or both. For companies importing or selling melanoma diagnostic tests, the outcome of Investigation No. 337-TA-1519 could directly affect market access and distribution of these products in the U.S. market.

Source: Federal Register, Vol. 91, No. 165, August 27, 2026, Notices, p. 55355 (official reference: FR Doc. 2026-17528).