Data from the Study Exceed Levels
Believed Necessary for a Commercially Successful Test
OncoCyte Corporation (NYSE MKT:OCX), a developer of novel,
non-invasive blood based tests to aid in the early detection of
cancer, today reported the successful completion of a critical step
in the development of its lung cancer diagnostic test. While the
key performance metrics of its diagnostic cannot be revealed until
they are presented at the American Thoracic Society Meeting in May,
the company has locked its prediction algorithm and intends to move
to the Clinical Validation Phase of development—the last phase
before commercial launch. The data from the study exceed levels
OncoCyte believes necessary for a commercially successful test and
the Company is moving forward with plans to launch the lung cancer
diagnostic test during the second half of 2017.
OncoCyte’s algorithm confirmed the results of an
earlier study by The Wistar Institute of Anatomy and Biology, which
reported its results at the CHEST 2016 Annual Meeting in October
2016. The Area Under the Curve (AUC) in Wistar’s study was 0.82
with a sensitivity of 90% and specificity of 62%. OncoCyte’s study
results were consistent with Wistar’s.
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.
OncoCyte’s assessment of the market leads
management to believe that it is positioned to be the first company
to provide a highly accurate non-invasive confirmatory blood test
for lung cancer. Based on published sources, Lung RADS
guidelines and NLST (National Lung Screening Trial) data, the
Company estimates that approximately 1.4 million patients annually
in the U.S. could benefit from its test. Assuming this number of
patients and the Company’s currently planned pricing for such a
test, the total addressable market could potentially exceed $4
billion. OncoCyte believes that its blood based lung cancer test
can provide Medicare and private insurance companies with
significant savings if the price of its product is about 20 to 25
percent of the cost of an invasive lung biopsy, which according to
recent Medicare estimates averages approximately
$15,000. Potential revenue to OncoCyte will depend in large
measure on the test’s market penetration and on approved
reimbursement by Medicare and health insurers.
The results of OncoCyte’s study will be
presented at The American Thoracic Society 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. "If the assay continues to perform at these
levels, it could create a significant improvement in the standard
of care in lung nodule management. Current practice can
result in patients undergoing avoidable invasive procedures, which
a diagnostic test of this type could help to reduce significantly,
while also lowering the cost to determine the presence of lung
cancer," said Dr. Vachani.
OncoCyte’s study utilized Wistar’s biomarker
panel, which has been exclusively licensed to OncoCyte. The study
developed and tested OncoCyte’s proprietary algorithm, using
approximately 300 samples collected from patients at 26 community
based, academic and government sites across the United States.
OncoCyte developed its algorithm by combining data from the top
mRNA biomarkers with clinical data such as nodule size. The
algorithm was self-tested via a six-fold internal cross-validation
on the samples. Cross-validation is a statistical method used
to develop and estimate the performance of an algorithm.
The samples were collected from patients with
nodules ranging in size from five to thirty millimeters, the size
range presenting the greatest diagnostic challenge to clinicians.
For patients with these size nodules, physicians must weigh the
risk of cancer against the risks posed by costly and potentially
dangerous invasive biopsies to confirm whether the nodules are
malignant or benign.
Because of the study’s successful results,
OncoCyte also announced that it will begin ramping-up its
commercial capabilities in anticipation of the potential launch of
the test. OncoCyte will initiate a Clinical Validation Phase for
this diagnostic. During this phase, the company will continue to
carry out analytical validation studies to refine its operational
stage laboratory processes and will apply for certification of its
CLIA diagnostic testing lab. Upon CLIA certification, OncoCyte 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.
OncoCyte then will begin a clinical validation study using the
finalized algorithm and operational procedures on a new set of at
least 300 blinded prospectively collected samples to confirm
whether the sensitivity and specificity of the test remain within
commercial parameters in a CLIA operational setting. Assuming
successful completion of these steps, OncoCyte anticipates
launching the test commercially in the second half of 2017.
“We are very excited about the successful
results of our study,” commented William Annett, President and
Chief Executive Officer. “Our goal is to have the first commercial
blood test that can help physicians to better manage patients
presenting with lung nodules, and to avoid a significant number of
risky and costly biopsies.”
Conference Call
The Company will host a conference call on
Monday, March 6, 2017 at 4:30 p.m. ET / 1:30 p.m. PT to discuss the
study results as well as its 2016 financial results. The
dial-in number in the U.S./Canada is 888-427-9421, for
international participants the number is 719-325-2450. For all
callers, refer to Conference ID 9994065. To access the live
webcast, go to the investor relations section on the company’s
website,
http://investors.oncocyte.com/events-and-presentations.
A replay of the conference call will be
available for seven business days beginning about two hours after
the conclusion of the live call, by calling 888-203-1112-toll-free
(from U.S./Canada); international callers dial +1 719-457-0820. Use
the Conference ID 9994065. Additionally, the archived webcast will
be available
http://investors.oncocyte.com/events-and-presentations.
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 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 validation study and other
studies, commercialization plans, 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.
Michael Polyviou/Amanda Prior
646-445-4800
mpolyviou@evcgroup.com /aprior@evcgroup.com