OncoCyte Submits Application for CLIA Certification of its Laboratory
March 21 2017 - 7:00AM
OncoCyte Corporation (NYSE MKT:OCX), a developer of novel,
non-invasive blood based tests to aid in the early detection of
cancer, has submitted its application for CLIA certification of its
laboratory, the next step towards its objective of launching the
Company’s first commercial product, a lung cancer diagnostic test,
in the second half of 2017. The Company expects to receive
the certification during the second quarter of 2017.
“This is an exciting next step for OncoCyte as
CLIA certification is a key component of our plan to commercially
launch our lung cancer diagnostic test during the second half of
this year,” commented William Annett, President and Chief Executive
Officer. “Upon receipt of CLIA certification we will conduct a
small CLIA lab validation study to demonstrate that the full assay
system utilized in the CLIA lab provides the same results on
clinical samples as those obtained in the R&D lab. Once this
lab validation study is completed, we will initiate a clinical
validation study of 300 blinded, prospectively collected samples.
If the results replicate the positive results of our prior study,
we will move to commercialization. Based on our estimate of
the number of patients who could be candidates for our lung cancer
diagnostic, we believe the total addressable market for the test
could be over $4 billion, depending on efficacy and reimbursable
pricing. Additionally, use of the test will reduce healthcare costs
for unnecessary biopsy procedures and complications.”
On March 6, 2017, OncoCyte reported the
successful results of its lung cancer diagnostic test and the
Company’s algorithm confirmed the results of an earlier study by
The Wistar Institute of Anatomy and Biology. The Area Under the
Curve (AUC) in Wistar’s study was 0.82 with a sensitivity of 90%
and specificity of 62%, exceeding levels OncoCyte believes are
necessary for a commercially successful test. The AUC of a test is
a measure that combines sensitivity and specificity to express its
total accuracy, with 1.0 being perfect accuracy and 0.50 being a
random result. Sensitivity and specificity are statistical measures
of test performance, with sensitivity measuring the percentage of
malignant nodules that are identified correctly by the test and
specificity measuring the percentage of benign nodules correctly
identified. The complete data results of OncoCyte’s R&D
study will be presented at The American Thoracic Society (ATS)
conference in May by its lead author, Dr. Anil Vachani, Associate
Professor of Medicine at the Hospital of the University of
Pennsylvania, located in Philadelphia, PA.
OncoCyte’s clinical laboratory is headed by
William K. Seltzer, a Board Certified Clinical Medical Geneticist.
He joined OncoCyte in September 2014 and in July of 2015 was
appointed Vice President of Clinical Services. Dr. Seltzer has 30
years of commercial and academic experience in clinical diagnostic
services and product development and commercialization, quality
assurance and regulatory compliance. Over the course of his career,
Dr. Seltzer has been responsible for the successful launch and
oversight of clinical services for over 100 Laboratory Developed
Tests (LDTs). He has published more than 50 articles in
peer-reviewed scientific journals and is co-inventor on patents for
molecular diagnostics and methods.
The Centers for Medicare & Medicaid Services
(CMS) regulates all laboratory testing (except research) performed
on humans in the U.S. through the Clinical Laboratory Improvement
Amendments (CLIA). In total, CLIA covers approximately 254,000
laboratory entities. The Division of Laboratory Services, within
the Survey and Certification Group, under the Center for Clinical
Standards and Quality (CCSQ) has the responsibility for
implementing the CLIA Program.
About OncoCyte
CorporationOncoCyte is focused on the development and
commercialization of novel, non-invasive blood and urine (“liquid
biopsy”) diagnostic tests for the early detection of cancer to
improve health outcomes through earlier diagnoses, to reduce the
cost of care through the avoidance of more costly diagnostic
procedures, including invasive biopsy and cystoscopic procedures,
and to improve the quality of life for cancer patients. While
current biopsy tests use invasive surgical procedures to provide
tissue samples in order to determine if a tumor is benign or
malignant, OncoCyte is developing a next generation of diagnostic
tests that will be based on liquid biopsies using blood or urine
samples. OncoCyte’s pipeline products are intended to be
confirmatory diagnostics for detecting lung, breast and bladder
cancer. OncoCyte’s diagnostic tests are being developed using
proprietary sets of genetic and protein markers that differentially
express in specific types of cancer.
Forward Looking StatementsAny
statements that are not historical fact (including, but not limited
to statements that contain words such as “will,” “believes,”
“plans,” “anticipates,” “expects,” “estimates” and similar
expressions) should also be considered to be forward-looking
statements. These statements include those pertaining to the
implementation and results of our diagnostic test studies,
commercialization plans, future financial and/or operating results,
future growth in research, technology, clinical development, and
potential market opportunities for OncoCyte’s diagnostic tests,
along with other statements about the future expectations, beliefs,
goals, plans, or prospects expressed by management. Forward-looking
statements involve risks and uncertainties, including, without
limitation, risks inherent in the development and/or
commercialization of potential diagnostic tests or products,
uncertainty in the results of clinical trials or regulatory
approvals, the need and ability to obtain future capital, and
maintenance of intellectual property rights, diagnostic test
pricing, and the need to obtain third party reimbursement for
patient’s use of any diagnostic tests we commercialize. Actual
results may differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the business of OncoCyte,
particularly those mentioned in the “Risk Factors” and other
cautionary statements found in OncoCyte’s Securities and Exchange
Commission filings. OncoCyte disclaims any intent or obligation to
update these forward-looking statements, except as required by
law.
Investor Contact:
EVC Group, Inc.
Michael Polyviou/Amanda Prior
646-445-4800
mpolyviou@evcgroup.com /aprior@evcgroup.com
Media Contact:
EVC Group, Inc.
Tom Gibson
201-476-0322
tom@tomgibsoncommunications.com