OncoCyte Receives CLIA Certification for its Cancer Diagnostics Laboratory
September 07 2017 - 7:00AM
OncoCyte Corporation (NYSE American:OCX), a developer of novel,
non-invasive tests for the early detection of cancer, today
announced that its clinical laboratory facility located in Alameda,
California, has received Clinical Laboratory Improvements
Amendments (CLIA) certification of registration from the Centers
for Medicare and Medicaid Services (CMS). In addition, OncoCyte’s
laboratory has passed inspection by the California Department of
Public Health and is now fully licensed and operational.
OncoCyte plans to use its CLIA-certified
laboratory to commercialize proprietary cancer diagnostic tests.
The Company expects to launch its first assay, DetermaVu™, a
confirmatory lung cancer diagnostic, in the fourth quarter of 2017,
assuming successful completion of CLIA Validation and Clinical
Validation studies. OncoCyte estimates that a $4.7 billion annual
market could develop in the U.S. for confirmatory lung cancer
liquid biopsy tests, depending on market penetration and
reimbursable pricing.
“Having our CLIA laboratory become operational
marks the beginning of our commercial activities in the U.S., a key
driver of our long-term success. The receipt of CLIA certification
is a testament to the dedication and proficiency of our operations
team in Alameda and I am grateful for the team members’ tireless
efforts in achieving this important milestone,” said Bill Annett,
President and CEO. “The demand for molecular diagnostic testing for
cancer is growing rapidly and CLIA certification of our laboratory
positions OncoCyte to enter this exciting emerging field.”
Mr. Annett continued, “We believe DetermaVu™
will aid physicians in the early diagnosis of lung cancer and in a
majority of cases eliminate the need for expensive, invasive lung
biopsies. We expect that a reduction in the number of lung biopsies
performed annually, coupled with improvements in treatment at an
early stage of disease, could lead to a significant reduction in
the cost burden to the healthcare system while improving the
survival rate of lung cancer patients.”
About CLIA
Under CLIA, a laboratory is defined as any
facility that performs laboratory testing on specimens derived from
humans for the purpose of providing information for the diagnosis,
prevention or treatment of disease, or the impairment of, or
assessment of health of human beings. CLIA requires that the
Company holds a certificate applicable to the complexity of the
categories of testing performed and that compliance with certain
standards. CLIA further regulates virtually all clinical
laboratories by requiring that they comply with various
operational, personnel, facilities administration, quality and
proficiency testing requirements intended to ensure that the
clinical laboratory testing services are accurate, reliable and
timely. CLIA certification is also a prerequisite to be eligible to
be reimbursed for services provided to state and federal health
care program beneficiaries.
About OncoCyte Corporation
OncoCyte 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.
DetermaVu™ is a trademark of OncoCyte
Corporation.
Forward Looking Statements
Any 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) are forward-looking
statements. These statements include those pertaining to the
implementation and results of research, development, clinical
trials and studies, commercialization plans, future financial
and/or operating results, and future opportunities for OncoCyte,
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, and the need to obtain
third party reimbursement for patients’ use of any diagnostic tests
we commercialize. Actual results may differ materially from the
results anticipated in these forward-looking statements and
accordingly such statements 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.
Matt Haines / Michael Polyviou
917-733-9297 / 212-850-5600
mhaines@evcgroup.com /mployviou@evcgroup.com
Financial Media Contact:
GIBSON Communications, LLC
Tom Gibson
201-476-0322
tom@tomgibsoncommunications.com