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Personalis Sues Foresight Diagnostics, Alleging Patent Infringement

NEW YORK — Cancer genomics company Personalis announced on Tuesday that it has filed a lawsuit against Foresight Diagnostics, alleging it infringed patents related to whole-genome sequencing.

The patents in question are US Patent Nos. 10,450,611; 11,299,783; and 11,384,394 and cover Personalis' intellectual property portfolio related to whole-genome-enabled, tumor-informed molecular residual disease testing. The patent portfolio involves work related to whole-genome sequencing to identify mutations indicating the continued presence or recurrence of cancer with parts per million sensitivity, Personalis said in a statement.

The Menlo Park, California-based company is seeking injunctive relief and monetary damages.

Elements of the patents are included in its NeXT Personal test, which uses whole-genome sequencing to identify up to 1,800 variants that are then used to create a personalized panel specific to each patient. The liquid biopsy test is intended to detect and quantify MRD and recurrence in patients previously diagnosed with cancer, particularly those with low levels of circulating tumor DNA, Personalis said.

The assay can also simultaneously detect and quantify clinically relevant mutations — such as known targetable cancer mutations, drug resistance mutations, and new variants — in ctDNA that can be used to help guide therapy in the future, the company added.

Stanford University spinout Foresight Diagnostics, meantime, is working on its PhasED-seq technology, which is based on the idea that the co-location of two or more mutations on ctDNA fragments could be used to reduce sequencing errors and increase sensitivity.

"Personalis has invested hundreds of millions of dollars in research and development across a broad array of disciplines for over a decade, and we stand firm in our resolve to protect that investment and our leadership position in the field," Personalis CEO John West said in a statement. "NeXT Personal is our most recent product leveraging our pioneering work. We believe that it represents the most sensitive MRD approach for solid tumors and can be transformational in cancer, detecting residual disease and recurrence, and in actively fighting cancer after recurrence has been detected."

Foresight Diagnostics did not respond to a request for comment.

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