Market Overview

Personalis, Inc. Receives Approval From the New York State Department of Health for Use of its ACE ImmunoID™ Platform in Cancer Immunotherapeutic Clinical Trials


Personalis, Inc., a leading provider of advanced genomic sequencing and
analytics for immuno-oncology (IO), today announced that it has received
approval from the New York State Department of Health for use of ACE
, its next-generation sequencing platform for the
development of personalized cancer vaccines and IO biomarker discovery,
in cancer immunotherapy clinical trials. The Personalis Clinical
Laboratory Permit
has been granted in the category of Oncology – Molecular and Cellular
Tumor Markers.

ACE ImmunoID, based on Personalis' proprietary ACE (accuracy and content
enhanced) technology, combines whole exome and transcriptome sequencing,
covering ~20,000 genes, with additional augmented coverage of more than
8,000 genes. As a result, ACE ImmunoID provides substantially more
uniform sequencing coverage than other commercially available exomes,
for comprehensive variant capture (SNVs, indels, and fusions), as well
as neoantigen detection for personalized cancer vaccine development.

The New York State Department of Health's Clinical Laboratory Evaluation
Program (CLEP) regulates and oversees clinical diagnostic laboratories
that test specimens from New York State residents, including Laboratory
Developed Tests (LDTs). The CLEP seeks to ensure the accuracy and
reliability of test results in clinical laboratories located in, or
accepting, specimens from New York State (NYS) residents.

"These genomic services can now be offered to our personalized cancer
vaccine and adoptive cell therapy partners for NY State residents
enrolled in their trials," said John West, Personalis CEO. "We believe
that Personalis is the first company to receive such an approval and
given the number of premier medical centers in New York State, this
creates a significant patient recruitment advantage for our customers."

This recognition adds to the certifications that the Personalis
Clinical Laboratory
(PCL) has previously received. The PCL has been
CLIA'88 and State of California licensed since 2013 and CAP (College of
American Pathologists) accredited since 2014.

About Personalis, Inc.

Personalis, Inc. (
is a leading precision medicine company focused on advanced NGS-based
services for immuno-oncology and cancer for clinical trials and
translational research.

The Personalis ACE Exome and Transcriptome technology is designed to
obtain the most comprehensive and accurate tumor molecular profile and
each tumor's unique immune microenvironment for immuno-oncology
applications. The company's Clinical
is GxP aligned as well as CLIA'88 and CAP accredited.
Personalis is differentiated by advanced sequencing assays, algorithms
and content for neoantigen characterization, customer regulatory
support, and more. Visit our website at
and follow @PersonalisInc.

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