On April 12, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the issuance of a key US Patent related to its industry-leading minimal residual disease (MRD) and recurrence platform, NeXT Personal (Press release, Personalis, APR 12, 2022, View Source [SID1234612087]).
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The patent, US Patent No. 11,299,783, entitled "Methods and Systems for Genetic Analysis," was issued on April 12, 2022. The ‘783 patent claims novel methods for a partially personalized assay, combining both tumor-informed and prespecified (tumor naïve) content. Tumor-informed methods can provide high sensitivity for detection of MRD. They can also support tracking of variants specific to an individual patient’s cancer, such as those targeted by specific therapies or which are thought to elicit an immune response. Prespecified, tumor-naïve content can include variants not detected on initial sequencing of a tumor, but which may emerge and confer drug resistance as a tumor evolves. It can also include driver mutations of a second primary tumor, which may arise independently during the course of the initial cancer. The ‘783 patent is a member of a patent family that broadly describes Personalis’ foundational work relating to the development of personalized assays for disease identification and tracking.
Personalis’ recently introduced NeXT Personal platform leverages many elements of the ‘783 patent. It is unique among MRD assays in that it combines a highly sensitive measurement of tumor burden with simultaneous tracking of thousands of tumor variants, both tumor-informed and prespecified, in a single panel design.
The issuance of the ‘783 patent adds to Personalis’ growing intellectual property portfolio that includes multiple early families related to personalized genetic testing. Overall, Personalis has 19 issued US and foreign patents, spanning 16 distinct families, relating to advanced genomic sequencing and analysis solutions. In addition, the company has over 25 pending US and foreign patent applications that relate to its existing advanced cancer detection platforms and novel research areas, including methods for interpreting genetic data generated by its platforms.
"Cancer is very complex and dynamic," said John West, CEO and co-founder of Personalis. "Our NeXT Personal approach combines detection, quantification, and detailed characterization of a patient’s tumor in a single, integrated data stream. As the cost and turnaround time of both DNA sequencing and DNA synthesis have rapidly improved, sensitive and detailed monitoring over a patient’s entire clinical trajectory has become affordable, and we believe that it will become the new standard of care."