USITC对Castle Biosciences发起的黑色素瘤检测337案立案调查

USITC Institutes Section 337 Investigation of Certain Melanoma Predictive and Prognostic Tests and Components Thereof
USITC Institutes Section 337 Investigation of Certain Melanoma Predictive and Prognostic Tests and Components Thereof
The U.S. International Trade Commission (USITC) voted to institute an investigation of certain melanoma predictive and prognostic tests and components thereof. The products at issue in the investigation are described in the USITC’s notice of investigation.
The investigation is based on a complaint filed on behalf of Castle Biosciences, Inc. of Friendswood, Texas, on July 10, 2026. The complaint alleges violations of section 337 of the Tariff Act of 1930 by reason of the upon the importation into the United States or in the sale of certain melanoma predictive and prognostic tests and components by reason of unfair competition through false advertising. The complainant requests that the USITC issue a limited exclusion order and cease and desist orders.
The USITC has identified the following respondents in this investigation:
- SkylineDx Holding B.V., Rotterdam, Netherlands
- SkylineDx USA, Inc., San Diego, California
- Qiagen GmbH, Hilden, Germany
- QIAGEN LLC, Germantown, Maryland
By instituting this investigation (337-TA-1519), the USITC has not yet made any decision on the merits of the case. The USITC’s Chief Administrative Law Judge will assign the case to one of the USITC’s administrative law judges (ALJ), who will schedule and hold an evidentiary hearing. The ALJ will make an initial determination as to whether there is a violation of section 337; that initial determination is subject to review by the USITC.
The USITC will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the USITC will set a target date for completing the investigation. USITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.