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TwinStrand Biosciences Sues Guardant Health for Alleged Patent Infringement

NEW YORK – TwinStrand Biosciences said Tuesday that it has filed a patent infringement lawsuit against Guardant Health, alleging that the liquid biopsy firm infringes multiple patents covering TwinStrand’s proprietary duplex sequencing method for generating highly accurate DNA sequence data.

Filed in US District Court in Delaware by TwinStrand and its exclusive licensor, the University of Washington, the lawsuit claims that Guardant's products employ various aspects of the duplex sequencing technology invented by TwinStrand CEO Jesse Salk and colleagues at the University of Washington.

Specifically, the company contends that the "Digital Sequencing Technology" used by Guardant in products it has been selling since 2014 employs methods covered by TwinStrand's asserted patents, and that this infringement has been willful on Guardant's part.

Salk and his team first described duplex sequencing in a 2012 paper in the Proceedings of the National Academy of Sciences. The method involves tagging each strand of a DNA duplex prior to amplification and sequencing in order to distinguish between errors and true mutations.

The firm launched its first commercial research-use kits in 2020 and has notably licensed the technology to cancer genomics firm Foundation Medicine for use in its liquid biopsy testing.

According to TwinStrand's complaint, Guardant has described the approach it calls "Digital Sequencing" as involving barcoding that allows complementary DNA strands to be compared to discern sequencing errors from mutations.

As evidence that Guardant knew that this technique infringes the UW duplex sequencing patents when it launched its various products, TwinStrand asserted that the firm made several unsuccessful attempts to license the duplex sequencing patent family, beginning with the launch of its first test, Guardant360.

Having failed to license the patents, Guardant then attempted and failed to cancel the exclusive license between UW and TwinStrand, according to the complaint.

"TwinStrand is committed to bringing its technology to patients, clinicians, and researchers through its own products, licensing, and other partnerships, but it will not allow the continued infringement of its patents,” Karen Dabbs, the firm's general counsel, said in a statement.

TwinStrand is seeking remedies including a permanent injunction against Guardant Health’s use and sale of all infringing products and services, as well as compensatory and enhanced damages for past infringement.

According to Dabbs, TwinStrand is also considering legal options against other parties "who directly infringe, or induce others to infringe, its patented technology."

Guardant Health did not respond to a request for comment before deadline.

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