Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, announced the issuance of a key US Patent related to its industry-leading minimal residual disease (MRD) and recurrence platform, NeXT Personal.

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.”

About Personalis

Personalis, Inc. is a leader in advanced cancer genomics, enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single sample. To enable cancer sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale, and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited. For more information, visit the Personalis website and follow Personalis on LinkedIn and Twitter.

Forward-Looking Statements

All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the NeXT or NeXT Personal platforms, Personalis’ business opportunities, leadership, plans, beliefs or expectations, the presumed validity or enforceability of the company’s patents, the potential issuance of additional patents from the company’s pending or future patent applications, or other future events. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis’ filings with the U.S. Securities and Exchange Commission, including Personalis’ most recent reports on Forms 8-K, 10-K and 10-Q, the company’s registration statement on Form S-3 filed on December 30, 2020, and the company’s prospectus supplement filed on January 3, 2022, and include those listed under the caption “Risk Factors.” Personalis disclaims any obligation to update such forward-looking statements.

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