Certain Melanoma Predictive and Prognostic Tests and Components Thereof; Inv. No. 337-TA-1519

The Commission instituted Investigation No. 337-TA-1519 based on Castle Biosciences, Inc.'s complaint alleging Section 337 violations through false and misleading advertising involving imported melanoma predictive and prognostic CP-GEP tests and related components. The named respondents are SkylineDx Holding B.V., SkylineDx USA, Inc., Qiagen GmbH, and QIAGEN LLC. This investigation targets competitive claims in the melanoma diagnostics market rather than patent infringement, focusing on alleged false advertising for predictive and prognostic gene-expression profiling tests. The requested limited exclusion order and cease-and-desist orders could affect access to competing melanoma test offerings and related components in the U.S. market. The investigation is instituted under Section 337(a)(1)(A) for alleged unfair competition through false advertising, not under patent-based Section 337 claims. The accused products are defined as melanoma predictive and prognostic CP-GEP tests and related components used in connection with such tests. The ALJ is directed to develop a record on the statutory public-interest factors, and respondents must answer within 20 days of service or risk default and remedial orders.