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 positive
final results from the Analytical Validation Study of its liquid
biopsy lung cancer diagnostic test, DetermaVU™. The data were
presented by Philip McQuary Ph.D., Director of Product Development,
OncoCyte Corporation, at the International Association for the
Study of Lung Cancer (IASLC), in Chicago.
The accuracy results of the Analytical
Validation Study reported today demonstrate sensitivity of 94.4%,
specificity of 67.5% and Area Under the Curve (AUC) of 0.93, which
means that 93 percent of the samples tested during the Analytical
Validation were correctly diagnosed. These data are consistent with
the data reported in May at the American Thoracic Society 2017
International Conference.
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
0.93 reported at the recent IASLC meeting means that 93 percent of
the samples were correctly identified.
The next step in the process leading to
commercial launch of DetermaVu is a CLIA Validation study, which is
now underway and expected to be completed in the third quarter of
this year. If the CLIA Validation study is successful, the final
step will be a Clinical Validation study, which is expected to be
completed in the fourth quarter of this year. If the Clinical
Validation study is successful, OncoCyte plans to launch DetermaVu.
OncoCyte believes that at launch DetermaVu will be the only
commercially available liquid biopsy lung cancer product in what
the Company estimates is an up to $4.7 billion annual market
opportunity in the U.S.
“The new data seen in the Analytical Validation
Study provide further evidence of the reliability of the DetermaVu
assay system in identifying cancerous nodules,” stated Lyndal
Hesterberg, Ph.D., Senior Vice President, Research and Development.
“These data give support our belief that physicians will be able to
use DetermaVu with confidence in their clinical practice to help
patients make more informed treatment decisions.”
William Annett, President and Chief Executive
Officer, commented, “We are excited that the results reported at
the IASLC conference confirm the positive data reported in May at
the American Thoracic Society meeting. If our upcoming Clinical
Validation study is successful, we intend to commercialize
DetermaVu in the fourth quarter of 2017.”
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 support
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.
OncoCyte believes that DetermaVu 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. The Company estimates that approximately 1.4 million
patients annually in the U.S. could benefit from the test.
Depending on market penetration and reimbursable pricing, 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 CLIA approved 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 is underway.
Upon successful 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. If the results of the study are consistent with
results to date, OncoCyte will launch DetermaVu.
The second study will be conducted post-launch
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.
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 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 / mployviou@evcgroup.com
Financial Media Contact:
GIBSON Communications, LLCTom
Gibson201-476-0322tom@tomgibsoncommunications.com