Personalis Files Second Patent Infringement Suit Against Foresight Diagnostics

Infringed patents part of industry-leading intellectual property position in whole genome, tumor-informed minimal residual disease testing

FREMONT, Calif.--(BUSINESS WIRE)-- Personalis, Inc. (Nasdaq: PSNL) today announced that the company has filed a second patent infringement suit against Foresight Diagnostics Inc. Personalis is seeking injunctive relief and monetary damages. This suit brings the total number of patents that Personalis alleges Foresight Diagnostics has infringed to seven.

The additional suit, filed in the U.S. District Court for the District of Colorado, alleges that Foresight improperly based its solid tumor minimal residual disease (MRD) approach on technology already patented by Personalis. The technology is protected by three patents that were issued recently to Personalis. These new patents have 2014 and 2016 effective filing dates based on claims of priority. They cover aspects of Personalis’ personalized genetic testing process, including whole genome sequencing of a cancer patient’s tumor sample. This sequencing is the basis for designing personalized tests that detect tumor-specific genetic variants in subsequent samples from the patient.

“This action and the additions to our growing patent estate reinforce our market leadership position in the MRD space as we continue to generate clinical evidence for our award-winning, ultra-sensitive NeXT Personal® assay,” added Chris Hall, President and CEO of Personalis. “We will continue to vigorously defend the investment we’re making in transforming the active management of cancer through breakthrough personalized testing.”

Personalis’ initial infringement suit against Foresight was filed in August 2022. It accuses Foresight of infringing four Personalis patents related to its solid tumor recurrence test. That suit has been stayed by the District Court pending the outcome of inter partes review proceedings (IPRs) before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO). The PTAB instituted IPRs of two of Personalis’ patents on June 13, 2023, and is expected to decide whether to institute IPRs of the other two patents later this year.

“The granting of these and other recent patents is the latest recognition of Personalis as an innovator and pioneer in our field,” said Stephen Moore, Personalis’ General Counsel. “These new patents are strengthened by the USPTO’s issuance of them in spite of prior art that forms the basis of Foresight’s existing IPR petitions. We will continue to aggressively protect our industry-leading patent portfolio and the value it provides to our investors, customers and patients.”

Personalis now has 39 issued patents. The patents at issue in Personalis’ second, most recent suit against Foresight Diagnostics are U.S. Patent Nos. 11,584,968, 11,643,685 and 11,649,507. The patents at issue in Personalis’ initial suit against Foresight last August are U.S. Patent Nos. 10,450,611, 11,299,783, 11,384,394 and 11,408,033.

About Personalis

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and Twitter.

Personalis 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 NeXT Personal or other Personalis assays or products, 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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Investors:

Caroline Corner

investors@personalis.com

415-202-5678

Media:

pr@personalis.com

Source: Personalis, Inc.