On August 2, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that it filed a lawsuit against Foresight Diagnostics Inc. for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394 (Press release, Personalis, AUG 2, 2022, View Source [SID1234617306]). These patents are part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed molecular residual disease (MRD) testing.
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Personalis’ patent portfolio protects its pioneering work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with part-per-million sensitivity. Personalis is seeking both injunctive relief and monetary damages based upon Foresight’s infringement of these patents.
"Personalis has been active in whole human genome sequencing from very early on. By 2013, when we first began filing the applications that led to the patents we are asserting against Foresight, Personalis had already received customer orders to sequence and analyze over 1,000 human genomes and had realized the power of utilizing whole genome sequencing alongside our advanced targeted sequencing methods," said Personalis CEO, John West.
Personalis launched its ultra-sensitive MRD solution, NeXT Personal, in late 2021. NeXT Personal leverages many elements of the asserted patents, including the use of whole genome sequencing to identify up to 1,800 variants that are specific to a patient’s cancer, thereby achieving superior signal-to-noise in the detection of ctDNA in plasma samples. NeXT Personal is purpose-built to accurately detect MRD in patient samples with low overall ctDNA, which is particularly important for cancers that have low shedding or low mutational burden, such as breast and prostate cancers, or soon after resection.
"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. 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," Mr. West added.
About NeXT Personal
NeXT Personal is a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify MRD and recurrence in patients previously diagnosed with cancer. The assay is designed to deliver industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. It leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. This may enable earlier detection across a broader variety of cancers and stages, including typically challenging early-stage, low mutational burden, and low-shedding cancers. NeXT Personal is also designed to simultaneously detect and quantify clinically relevant mutations in ctDNA that may be used in the future to help guide therapy when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants that can emerge and change over time, especially under therapeutic pressure.