OncoCyte Analytical Validation Study of its Lung Cancer Diagnostic Test Confirms Previously Published Results
July 24 2017 - 07:00AM
- Abstract to Present Complete Study
Findings Submitted to a Scientific Conference -
OncoCyte Corporation (NYSE MKT:OCX), a developer
of novel, non-invasive blood-based liquid biopsy tests to assist in
the early detection of cancer, announced today that it has
successfully completed the Analytical Validation study of its
liquid biopsy lung cancer diagnostic test. The results are
consistent with the data reported in May at the American Thoracic
Society 2017 International Conference (ATS), which demonstrated
sensitivity of 95%, specificity of 73%, and Area Under the Curve
(AUC) of 0.92. (An AUC of .92 means that 92% of samples were
correctly identified.) The final development step before the
commercial launch of the lung cancer diagnostic test will be
Clinical Validation, which has commenced with a planned completion
in the fourth quarter of this year. If Clinical Validation is
successful and OncoCyte’s clinical laboratory receives CLIA
certification, then the lung cancer test will be the only
commercially available product in what the Company estimates is an
up to $4.7 billion annual market opportunity in the U.S.
Analytical Validation
The studies required for Analytical Validation
have been established in the CLSI (Clinical Lab Standards
Institute) Guidelines. These guidelines cover the testing for
such matters as limits of quantitation,
precision, reproducibility, and interfering substances.
OncoCyte has completed all of these studies successfully.
The new Analytical Validation data supports
expectations that the test’s performance will continue to be
robust. The completion of the study establishes the performance
characteristics of OncoCyte’s lung cancer diagnostic test and, if
the Clinical Validation studies are successful, will allow for
industrial scale operations under real world conditions. The
Company has submitted an abstract to present the data at a
scientific conference this year.
“The data seen in this study ensure reliable and
actionable liquid biopsy test results that physicians can use in
clinical practice to help patients make more informed treatment
decisions,” stated Lyndal Hesterberg, Ph.D., Senior Vice President,
Research and Development. “The successful completion of the
Analytical Validation study is an important milestone as we
progress toward commercialization of the test in the second half of
2017 following CLIA certification of the Company’s laboratory and
completion of the Clinical Validation stage.”
“We estimate that our lung cancer confirmatory
diagnostic could result in a substantial reduction in the number of
unnecessary, expensive lung biopsies performed annually in the
U.S., thereby representing a fundamental advancement in the more
accurate diagnosis of suspicious lung nodules by allowing
physicians to determine which patients need biopsies versus those
who may only need follow-up imaging,” said William Annett,
President and Chief Executive Officer. “We estimate that
approximately 1.4 million patients annually in the U.S. could
benefit from the test. Depending on market penetration and
reimbursable pricing, we believe this could translate into a market
opportunity of up to $4.7 billion annually.”
Clinical Validation Stage
Underway
The final stage of development following the now
completed Analytical Validation Study is Clinical Validation. This
stage consists of two distinct sets of studies that will be carried
out in OncoCyte’s new clinical laboratory. The first step is CLIA
Lab Validation. In this study, OncoCyte will assay approximately
120 samples previously tested in the 299-patient study presented at
the ATS meeting, with the goal of demonstrating that OncoCyte’s new
clinical laboratory provides the same results on clinical samples
as those obtained in OncoCyte’s R&D lab. This study has now
begun.
On completion of the CLIA Lab Validation study
the second step will be two CLIA Lab Clinical Validation studies.
In these studies, OncoCyte will perform assays on blinded
prospectively collected samples to assess the performance of the
full diagnostic system against clinically confirmed diagnoses.
OncoCyte will perform Clinical Validation on two sets of samples.
The first study will consist of approximately 300 samples, and if
the results of the study are consistent with results to date
OncoCyte will launch its liquid biopsy lung cancer diagnostic test.
All of the samples required for this first study have now been
collected.
The second study will be conducted post-launch
and on approximately 200 additional samples to provide
additional data to increase the likelihood that physicians will
adopt the test and that insurance companies and Medicare will
provide reimbursement coverage for the test.
CLIA Certification
OncoCyte’s clinical laboratory must receive
Clinical Laboratory Improvement Amendment (CLIA) certification from
the state of California. The Company’s complete application for
CLIA certification was submitted in March 2017 to the California
Department of Public Health and is now under active review.
The Company expects to receive CLIA certification during the second
half of 2017.Diagnostic Test Accuracy
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 AUC of a test is a measure of overall
global accuracy that combines sensitivity and specificity, with 1.0
being perfect accuracy and 0.50 being a random result. The score of
0.92 reported at the recent ATS meeting means that 92% of samples
were correctly identified.
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.
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 our future financial and/or operating
results, future growth in research, technology, clinical
development, and potential 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 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.
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