- Continues Plans to Commercialize Lung
Cancer Diagnostic Test in 2017 -
OncoCyte Corporation (NYSE MKT:OCX), a developer of novel,
non-invasive blood-based liquid biopsy tests for the early
detection of cancer, today reported positive new results in its
development of a highly-accurate blood-based lung cancer
diagnostic. Data from a multi-site study further validate the
test’s commercial potential and support OncoCyte’s plans to
commercialize its first product, a confirmatory test for lung
cancer, later this year. If successful, OncoCyte’s test could
eventually replace a high percentage of invasive, risky, and
expensive lung biopsies with simple blood tests, improving outcomes
for patients while also capturing significant cost savings for the
U.S. healthcare system. The results were reported today in a poster
presentation by Dr. Anil Vachani, at the American Thoracic Society
2017 International Conference in Washington, D.C.
A PDF accompanying this release is
available at http://www.globenewswire.com/NewsRoom/AttachmentNg/b3ce3fea-2aa3-4f97-ae67-54a3905094df
Dr. Vachani, Associate Professor of Medicine at
the Hospital of the University of Pennsylvania, reported that in a
study of 299 samples collected prospectively from 29 U.S. sites,
the optimized final predictive algorithm demonstrated sensitivity
of 95%, specificity of 73%, and Area Under the Curve (AUC) of
0.92.
Results from this study of the optimized final
predictive algorithm confirmed the data from a previous 610-sample
study that was reported in October 2016 by the Wistar Institute
(OncoCyte’s research partner) at the American College of Chest
Physicians CHEST 2016 Annual Meeting. The development of the lung
cancer diagnostic test is a result of nearly ten years of research
and the analysis of thousands of samples by Wistar, followed by
improvement from OncoCyte’s current study.
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 reported
score of 0.92 means that 92% of samples were correctly
identified.
OncoCyte believes the results reported today
significantly exceed levels necessary for a commercially successful
test.
“The robust lung cancer diagnostic test study
data suggest that OncoCyte’s potential lung cancer confirmatory
diagnostic could result in a major reduction in the number of risky
and costly lung biopsies performed annually in the U.S.,” said Dr.
Vachani. “I believe this test could represent a fundamental
advancement in the more accurate diagnosis of suspicious lung
nodules by allowing physicians to determine those who need biopsies
as opposed to those who need follow-up imaging.”
William Annett, President and Chief Executive
Officer, commented, “Based on the predictive level of our new
algorithm, we believe we are well positioned to be the first
company to provide a novel, highly accurate test to a patient
market that could reach $4 billion annually, depending on market
penetration and reimbursable pricing. We believe we will have the
first-mover advantage that could be sustained for at least several
years.”
The Company’s health economics research
indicates that its lung cancer diagnostic test could mitigate the
need for hundreds of thousands of unnecessary lung biopsies.
Because lung biopsies have significant safety risks, these
unnecessary lung biopsies could result in thousands of consequent
hospitalizations and deaths annually. Reducing the number of
these biopsies therefore would also reduce their cost burden to
private health insurers and Medicare by billions of dollars.
OncoCyte’s surveys of physicians and payors have consistently
indicated a strong desire for a test that could reduce the number
of lung biopsies, and the expectation is that such a test would be
adopted quickly by both prescribers and payors. 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.
Development and Commercialization
Path
For the study presented at the ATS conference,
OncoCyte and its investigative partners first created an algorithm
that roughly matched the Wistar study results using all 200
biomarkers included in the Wistar algorithm, and OncoCyte then
optimized the algorithm’s performance by using only those
biomarkers with the highest predictive ability. In addition, the
Company’s new algorithm also factors in size of the lung
nodule.
OncoCyte has now locked the algorithm of its
test and is preparing to commercialize it. During the next few
months, the Company plans to complete analytical validation studies
and anticipates CLIA certification of its testing laboratory in
mid-2017. 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 its R&D lab.
Upon CLIA certification, OncoCyte will carry out
a final clinical validation study using the locked algorithm and
finalized operational procedures on a new set of blinded
prospectively collected samples in order to confirm that the
sensitivity and specificity of the test remains within commercial
parameters in the CLIA operational setting. This final study is not
required before commercialization. However, the Company believes
that the results of this study should enhance the probability of
rapid adoption as the new standard of care for confirming diagnoses
of lung cancer. Assuming successful completion of these steps,
OncoCyte anticipates launching the test in the second half of 2017.
Subsequent to the launch, OncoCyte plans a continued program of
clinical utility and health economics studies to support adoption
of the test by the medical community, and reimbursement from third
party payers such as Medicare and health insurers. OncoCyte also
plans to conduct additional biomarker research and clinical studies
to develop improved versions of its test that could have even
higher accuracy or extend the intended use to additional patient
profiles.
About the Lung Cancer Diagnostic Test
Study and Poster Presentation
OncoCyte’s lung cancer diagnostic 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 29 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 samples were collected from patients with
nodules ranging in size from five to 30 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.
The original abstract was submitted in December
2016 for presentation at the American Thoracic Society 2017
International Conference, and was based on the analysis of 106
samples completed at that time. Subsequent to the submission
of that abstract, which was published in the ATS conference guide,
the analysis was completed on the full set of 299 samples and the
results of that analysis were presented in the final poster, which
is attached to this release.
Conference Call
OncoCyte will host a conference call today at
4:30 p.m. EDT / 1:30 p.m. PDT to discuss the study results.
The dial-in number in the U.S./Canada is
888-359-3610, for international participants the number is +1
719-457-2648. For all callers, refer to Conference ID 7395442. 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 7395442. Additionally, the archived webcast will
be available at
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 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) 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.
Doug Sherk / Matt Haines
646-445-4800
dsherk@evcgroup.com / mhaines@evcgroup.com
Financial Media Contact:
GIBSON Communications, LLC
Tom Gibson
201-476-0322
tom@tomgibsoncommunications.com