Personalis, Inc. Announces the Launch of the NeXT Dx™ Test, a Comprehensive Genomic Cancer Profiling Test Enabling Advanced Composite Biomarkers for Cancer Treatment

MENLO PARK, Calif.–(BUSINESS WIRE)–#immunotherapy–Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced the launch of the NeXT Dx™ Test to help oncologists identify potential therapies and clinical trial options for cancer patients. The Personalis NeXT Dx™ Test is one of the first cancer diagnostic platforms to profile approximately 20,000 genes in both the tumor exome and transcriptome, providing a comprehensive genomic testing solution that goes beyond many existing cancer diagnostic panels that focus on a few hundred genes. The Personalis NeXT Dx Test includes advanced analytics to provide a diagnostic report on genetic alterations in medically-important cancer genes, as well as emerging immunotherapy composite biomarkers of medical importance. Additionally, immunotherapy-related biomarkers such as microsatellite instability (MSI) status and tumor mutational burden (TMB) are included in the clinical report.

“With new cancer immunotherapy and combination therapies, there is an increasing need for the development of more advanced composite biomarkers that can model the complex biology driving the response and resistance to cancer therapy. Our NeXT Dx Test provides oncologists with clinical reports on key diagnostic markers driving therapies today as well as provides information that can support the identification of new, advanced biomarkers. With the NeXT Dx Test, we look forward to expanding engagements with both leading clinical cancer centers as well as biopharmaceutical companies looking to push forward cutting-edge precision medicine in cancer,” said Dr. Richard Chen, MD, Chief Scientific Officer at Personalis.

About NeXT Dx Test

The NeXT Dx Test, optimized for formalin-fixed, paraffin-embedded tumor samples, is a laboratory-developed test performed at Personalis’ CAP-accredited and CLIA’88-certified laboratory. The test utilizes ImmunoID NeXT™, a high-accuracy, clinical-grade, next-generation sequencing and analysis platform, to report base substitutions, insertions/deletions, gene fusions, and copy number alterations in cancer driver genes of clinical significance. Additionally, MSI status is reported based on five canonical loci (BAT25, BAT26, NR-21, NR-24, and NR-27), and TMB status is reported by leveraging the exome-wide analysis of non-synonymous somatic mutations. Based on the tumor’s molecular profile, the report delivers relevant therapy recommendations and appropriate clinical trial matches. Each case is reviewed by a team of board-certified molecular geneticists and genetic counselors. Test results are electronically delivered to the ordering clinician.

About ImmunoID NeXT Platform

ImmunoID NeXT is a universal cancer immunogenomics platform that consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its tumor microenvironment from a single sample. The platform represents an end-to-end solution for immuno-oncology and supports precision oncology biomarker discovery applications. It combines the pioneering NeXT assay (whole exome and transcriptome sequencing), sophisticated analytics engines, and quality support to provide researchers with comprehensive immunogenomic data to drive their drug development programs.

About Personalis, Inc.

Personalis, Inc. is a growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. The company’s NeXT^TM Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. Personalis also provides genomic information to the VA Million Veterans Program as part of their goal to sequence over a million veteran genomes. The Personalis Clinical 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

This press release contains or may imply “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding the extent to which Personalis will realize increased engagement with clinical cancer centers and biopharmaceutical companies as a result of the NeXT Dx Test. These forward-looking statements are subject to risks and uncertainties, including those discussed in Personalis’ filings with the Securities and Exchange Commission (SEC), including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Personalis disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

Contacts

Investor Relations Contact for Personalis:
Caroline Corner

[email protected]
415-202-5678

Media Contact for Personalis:
Jennifer Havlek

[email protected]
www.personalis.com
650-752-1300