A Major Legal Setback for Guardant Health
In a decisive move for the biotech industry, a U.S. District Court in Delaware has entered a final judgment against Guardant Health. The court ordered the company to pay more than $245.2 million to TwinStrand Biosciences and the University of Washington (UW) for the willful infringement of core DNA sequencing patents.
The judgment, finalized on August 21, 2026, reinforces a jury verdict from November 2023. The legal dispute centered on Duplex Sequencing technology—a breakthrough method that addressed long-standing accuracy issues in the DNA sequencing field, enabling more reliable early cancer detection and post-treatment monitoring.
Impact on Products and Ongoing Royalties
The court identified 11 Guardant Health products and services that incorporated the infringing technology. Guardant must now provide quarterly accountings of U.S. sales for these products and pay an ongoing 6% royalty until March 2033. The affected portfolio includes:
- Guardant360 Lab Developed Test and Guardant360 CDx
- GuardantOMNI and Guardant360 Response
- Guardant Reveal / LUNAR-1 and Guardant LUNAR-2 / Shield
- Guardant360 TissueNext, Guardant HEME, and Guardant COMPANION
- GuardantINFINITY / Sirius and Guardant EXPLORE
Duplex Sequencing solved an accuracy problem the sequencing field had worked on for years, and this judgment affirms the jury’s finding that Guardant Health built products on that invention without a license.
— Chad Waite, chair of the TwinStrand board of directors
What Happens Next?
Despite the magnitude of the judgment, the legal battle may not be over. Guardant Health has stated its intention to appeal the court’s decision. The company has expressed particular disagreement with the 6% ongoing royalty stipulation. For now, the judgment stands as a major validation of TwinStrand's intellectual property, cementing the importance of protecting research breakthroughs in the highly competitive cancer diagnostics market.