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, Calif.–(BUSINESS WIRE)– 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.
About Personalis, Inc.
Personalis, Inc. (www.personalis.com)
is a leading precision medicine company focused on advanced NGS-based
clinical diagnostic, clinical trial and research services for cancer and
inherited genetic disease. Personalis also provides DNA sequencing and
data analysis of human genomes.
The company’s clinical laboratory is CLIA licensed and CAP accredited.
Visit our website at www.personalis.com
and follow @PersonalisInc.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170424006346/en/
Contacts
Media Contact for Personalis:
Jennifer Havlek, 650-752-1300
pr@personalis.com
www.personalis.com
Source: Personalis, Inc.
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