Personalis Announces Issuance of US Patents Related to the Exome-Wide NeXT Liquid Biopsy Platform

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced the issuance of two key US Patents related to its high-performance, exome-wide liquid biopsy platform, NeXT Liquid Biopsy^™.

The first patent, US Patent No. 11,142,802, entitled “Methods for Using Mosaicism in Nucleic Acids Sampled Distal to Their Origin”, issued on October 12, 2021. The ‘802 patent claims novel methods for identifying cancer mutations by comparing the sequence of cell-free nucleic acids found in the plasma to the individual’s “normal” genome, obtained from leukocytes or PBMCs, also isolated from the blood sample.

For later stage cancer patients with substantial tumor DNA in their plasma, this comparison helps discriminate true somatic variants from those of their germline genome. For earlier stage patients, with much less tumor DNA in their plasma, this method can help discriminate tumor variants from mosaicism elsewhere in the body, often referred to as CHIP.

The second patent, US Patent No. 11,155,867, entitled “Methods and Systems for Genetic Analysis”, issued on October 26, 2021. The ‘867 patent claims a novel method for the deep sequencing of a clinically-relevant exome from a cell-free nucleic acid sample. The sequencing is accomplished using capture probe techniques that target one or more genomic features, which might be missed if using just a standard exome. This technology may reveal more of the cancer biology of a patient, enabling new drug development insights or better treatment options. As the liquid biopsy field moves on from first generation small panels to next generation exome scale, and drives towards higher sensitivity, these methods will become increasingly important.

Both the ‘867 and ‘802 patents are members of broader patent families that relate to Personalis’ early work relating to exome-wide analysis and the cell-free detection of disease. These families claim priority to applications filed in 2013 and 2014, respectively.

“We are pleased that the USPTO has recognized Personalis’ continued innovation for the exome-scale, cell-free detection of nucleic acids for the detection of disease,” said Dr. Leslie Grab, VP of Intellectual Property at Personalis. “The issuance of these patents further strengthens the company’s significant intellectual property estate in the field of advanced cancer detection and analysis.” To date, Personalis has been granted 18 US and foreign patents 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 as well as novel research areas, including methods for interpreting genetic data generated by its platforms.

“For over ten years, Personalis has been focused on innovation,” said John West, Personalis’ Chief Executive Officer. “Our IP portfolio now spans 16 families, which cover important areas including liquid biopsy methods, personalized genetic testing, advanced biomarkers based on neoantigen characterization and HLA-loss, and more.”

About Personalis, Inc.

Personalis, Inc. is a leader in advanced cancer genomics for 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 tissue sample. In population sequencing, Personalis operates one of the largest sequencing laboratories globally and is currently the sole sequencing provider to the VA MVP. To enable cancer and population sequencing, the Personalis Clinical Laboratory has been built with a focus on clinical accuracy, quality, big data, scale, and efficiency. The laboratory is GxP aligned as well as CLIA’88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

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 Personalis NeXT Platform, the company's business opportunities, leadership, plans, vision or growth, 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, including those related to the COVID-19 pandemic, 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 the company's most recent reports on forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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Personalis Announces Issuance of US Patents Related to the Exome-Wide NeXT Liquid Biopsy Platform