Personalis, Inc. Receives Approval from the New York State Department of Health for Clinical Tests Based on the ACE Exome
Tests based on the ACE Exome have passed Regulatory, Quality Standards, Clinical and Technical review by New York State’s Clinical Laboratory Evaluation Program
Menlo Park, CA – April 24, 2017 – Personalis, Inc., a leading provider of genomic sequencing and genome-based diagnostics for precision medicine, announced today that it has received approvals from the New York State Department of Health for two next-generation sequencing clinical tests based on the Personalis ACE Exome for Inherited Disorders. The Personalis Clinical Laboratory Permit has been granted in the category of Genetic Testing, Molecular.
The ACE Exome, based on Personalis’ proprietary ACE (accuracy and content enhanced) technology, covers all ~20,000 RefSeq genes and augments coverage of more than 8,000 biomedically relevant genes, for substantially more uniform sequencing coverage than other commercially available exomes.
These molecular tests can now be offered to physicians and patients in New York State. Gaining approval from New York State is in line with Personalis’ overall regulatory strategy for its family of products based on the ACE Exome.
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.
“This achievement represents an important milestone our regulatory strategy,” said John West, Personalis’ CEO,”We look forward to continuing to work with New York State for the evaluation and approval of other tests based on Personalis’ ACE technology.”
This recognition adds to the certifications that the Personalis Clinical Laboratory (PCL) previously received. The PCL has been CLIA’88 and State of California licensed since 2013 and CAP (College of American Pathologists) accredited since 2014.