On August 17, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it has filed an amended complaint against Foresight Diagnostics (Press release, Personalis, AUG 17, 2022, View Source [SID1234618465]). The amended complaint asserts a newly-issued patent in Personalis’ growing intellectual property portfolio relating to detection of molecular residual disease (MRD).
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The patent, US Patent No. 11,408,033 (the "‘033 patent"), which issued on August 9, 2022, claims priority to one of Personalis’ earliest patent families. It covers personalized MRD panels combining tumor-informed and database-derived content. This combination supports the detection, quantification, and characterization of a tumor over time, by sequencing circulating tumor DNA (ctDNA) of the individual.
On August 2, 2022, Personalis filed a complaint against Foresight for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394. These three patents are also part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed MRD testing. Personalis continues to seek both injunctive relief and monetary damages based upon Foresight’s infringement.
"The granting of the ‘033 patent provides further recognition of Personalis as a pioneer in the field of leveraging whole genome sequencing for clinical applications," said John West, CEO and co-founder of Personalis. "We stand firm in our resolve to protect our investment and leadership position in the field."
Personalis’ patent portfolio protects its groundbreaking work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with an unprecedented part-per-million sensitivity, which its recently-launched MRD solution, NeXT Personal, is uniquely designed to achieve. See the recent conversation series with John West on the Personalis Blog for more background on Personalis’ ultra-sensitive NeXT Personal assay.
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.