U.S. International Trade Commission Receives New Complaint: Public Comments Needed

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The U.S. International Trade Commission (USITC) recently announced the receipt of a complaint. The complaint is titled “Certain Melanoma Predictive and Prognostic Tests and Components Thereof,” and is identified as “DN 3921.”

The USITC is asking the public for comments. The focus is on any public interest issues concerning the complaint. The Commission’s Rules of Practice and Procedure allow for this public input.

Castle Biosciences, Inc. filed the complaint on July 10, 2026. The complaint claims there have been violations of section 337 of the Tariff Act of 1930. This section addresses unfair practices in import trade. The alleged violations involve the importation and sale of certain melanoma tests.

The complaint lists four respondents. They include SkylineDx Holding B.V. from the Netherlands and SkylineDx USA, Inc. from San Diego, California. Qiagen GmbH from Germany and QIAGEN LLC from Germantown, Maryland, are also named.

Castle Biosciences wants the Commission to take action. They ask for a limited exclusion order and cease and desist orders. They also want a bond set during the 60-day Presidential review period.

The Commission seeks comments from various stakeholders. Proposed respondents, interested parties, and government agencies are invited to provide input.

The Commission is interested in several key points:

  • How the melanoma tests are used in the United States.
  • Any public health concerns related to the requested orders.
  • Availability of similar articles made in the U.S. that can replace the subject tests.
  • Ability to replace the volume of possibly excluded articles quickly.
  • Impact of the orders on U.S. consumers.

Comments must be submitted within eight days of this notice. Further commenting opportunities will be available after a final initial determination. Submissions should refer to Docket No. 3921. They are limited to five pages.

All documents must be filed electronically. The Commission will accept filings through their Electronic Document Information System (EDIS). Guidance on electronic filing is available in the Handbook for Electronic Filing Procedures.

Confidential submissions are allowed, but must be properly justified. These will be treated according to the Commission’s regulations.

The action is authorized under section 337 of the Tariff Act of 1930. The Commission’s Rules of Practice and Procedure also govern the process.

Sharon Bellamy, Supervisory Hearings and Information Officer, issued this notice. It was filed on July 14, 2026, and published in the Federal Register.


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