Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, announced today it has filed an amended complaint against Foresight Diagnostics. The amended complaint asserts a newly-issued patent in Personalis’ growing intellectual property portfolio relating to detection of molecular residual disease (MRD).

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.

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, or expectations, legal proceedings to enforce patents, the presumed validity or enforceability of the company’s patents or other intellectual property rights, 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, and include those listed under the caption “Risk Factors.” Personalis disclaims any obligation to update such forward-looking statements.

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