OncoCyte Announces Successful Completion of CLIA Lab Validation Study of its DetermaVu™ Lung Cancer Diagnostic Test; Clinic...
September 27 2017 - 7:00AM
OncoCyte Corporation (NYSE American:OCX), a
developer of novel, non-invasive, blood-based liquid biopsy tests
to assist in the early detection of cancer, announced today that
its CLIA laboratory has successfully completed a rigorous
validation study of DetermaVu™, OncoCyte’s diagnostic test for lung
cancer. In this study, OncoCyte assayed approximately 120 samples
previously tested in its 299-patient study presented at the
American Thoracic Society conference in May 2017, with the goal of
demonstrating that OncoCyte’s new clinical laboratory provides the
same results on clinical samples as those obtained in its R&D
lab. The results met all performance criteria, demonstrating
the accuracy and robustness of the assay as performed in the
Company's CLIA laboratory. The CLIA lab validation study included
specific protocols to confirm the accuracy, reproducibility, and
precision/repeatability of DetermaVu™.
“The laboratory staff and procedures in place in
the clinical laboratory have been confirmed to provide accurate,
reliable, consistent and reproducible results,” said William
Seltzer, PhD, FACMG, VP of Clinical Services and the Laboratory
Director for OncoCyte. “The results were consistent with the
positive data reported at the American Thoracic Society 2017
International Conference, and have enabled us to initiate our
Clinical Validation Study, the final step prior to the commercial
launch of DetermaVu™.”
The Clinical Validation Study has now begun and
is expected to be completed in the fourth quarter of 2017. In this
study, approximately 300 new blinded blood samples, which have been
prospectively collected will be assayed in the CLIA lab using
DetermaVu™. The performance of the test will be assessed against
the clinical diagnosis of the patients from whom the samples were
collected. If the Clinical Validation Study is successful and the
results meet commercial requirements, OncoCyte will commence the
commercial launch of DetermaVu™.
“Successful completion of the CLIA Lab
Validation Study is another important step toward launching
DetermaVu™,” said William Annett, President and Chief Executive
Officer. “We plan to complete the ongoing Clinical Validation Study
in the fourth quarter.”
OncoCyte believes that widespread utilization of
DetermaVu™ could result in a substantial reduction in the number of
unnecessary, expensive lung biopsies performed annually in the
U.S., with a corresponding reduction in the surgical risk to
patients undergoing biopsy procedures. Broad use of
DetermaVu™ would result in a fundamental advancement in the
diagnosis of suspicious lung nodules by allowing physicians to
determine more accurately which patients need biopsies and which
patients only need follow-up imaging. The Company estimates that
approximately 1.4 million patients annually in the U.S. could
benefit from the DetermaVu™ test. Depending on market penetration
and reimbursable pricing, this could translate into a market
opportunity of up to $4.7 billion annually.
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 as 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 Polyviou917-733-9297 /
212-850-5600mhaines@evcgroup.com / mpolyviou@evcgroup.com
Financial Media Contact:
GIBSON Communications, LLCTom
Gibson201-476-0322tom@tomgibsoncommunications.com