MENLO PARK, Calif.--(BUSINESS WIRE)--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 ImmunoID, 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. (www.personalis.com) 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 Laboratory 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 www.personalis.com and follow @PersonalisInc.