Breast Cancer Test Development Three to Six
Months Ahead of Schedule; Commercial Launch Possible in Mid to Late
2018
OncoCyte Corporation (NYSE MKT:OCX), a developer of novel,
non-invasive blood and urine based tests for the early detection of
cancer, today provided an update on the development of its product
portfolio that currently includes a lung cancer diagnostic test, a
breast cancer diagnostic test and a bladder cancer diagnostic test.
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.
“We enter 2017 with a focus on late stage
development as we prepare to commercialize our diagnostic tests,
which address much larger opportunities than most other diagnostic
tests. We have heard consistently from physicians and health
insurers that our tests are very much needed to help avoid costly,
invasive and unnecessary procedures,” said William Annett,
President and CEO of OncoCyte. “Our breast cancer test
development is now progressing ahead of schedule and we anticipate
achieving additional development milestones for this program in the
year ahead. Our work in developing the lung cancer diagnostic test
is proceeding across the clinical study, product development, CLIA
lab, and commercial areas. The clinical study timeline has been
delayed by slower than expected sample collection; while we have
received all of the benign samples that we need for our study we
require an additional 7 to 14 malignant samples. We expect to
complete the next steps of the lung test development process during
the first quarter of the year. We continue to be excited
about the positive data that was reported for our bladder cancer
test at ASCO in June 2016, but are likely to seek a
commercialization partner because (unlike our lung and breast
cancer tests) the marketing challenges of the bladder cancer test
would likely require the resources of a larger company.
OncoCyte is committed to developing high value tests that
address large market opportunities while keeping our cash burn rate
low prior to commercialization.”
Breast Cancer Diagnostic Test
Development Ahead of Schedule
OncoCyte today reported the commencement of a
biomarker training and optimization study as the next phase of
development of its internally developed breast cancer diagnostic
test. This study will use blood samples from 300 benign and
malignant breast cancer patients, all of which have now been
collected. The purpose of the optimization and training study is to
attempt to replicate the successful findings that were presented by
OncoCyte at the San Antonio Breast Cancer Symposium (SABCS) in
December. OncoCyte reported on its initial 100 sample study
of a novel panel of serum protein biomarkers designed to allow for
the non-invasive and sensitive detection of breast cancer in
BI-RADS category 4 patients. The 15-marker model resulted in
an area under the curve (AUC) of 0.92 sensitivity of 90% and
specificity of 76%. 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 expects
to complete this 300-patient study during mid-2017, which would put
development of the diagnostic test substantially ahead of the
previously announced schedule.
“The results we reported at SABCS were well
received by clinicians and researchers and have led our team to
dedicate more resources to our breast cancer diagnostic test
development program,” said Mr. Annett. “If our efforts are
successful, our test will address one of the more pressing needs in
oncology today…the need to reduce over-treatment of women with
suspicious breast imaging findings. Our next phase of
development for this test is to attempt to replicate the findings
presented at SABCS in a larger, approximately 300-patient
study. At this point, we are ahead of our internal
development plan for this test by three to six months and believe
we may be able to commercially launch it in mid to late 2018.”
Each year approximately 38 million women in the
United States undergo mammogram screenings. Mammograms detect
suspicious lumps or masses in about 1.5 to 2 million of these
women, known as BI-RADS category 4 patients, who then are referred
for an invasive follow-on breast biopsy to determine if the mass is
malignant or benign. However, only about 20% of these
biopsies result in a cancer diagnosis. Consequently, the majority
of breast biopsies are not needed and can result in unnecessary
pain, discomfort and anxiety to women as well as an estimated $2.8
billion annual cost to the healthcare system. OncoCyte’s test is
designed to be used as an adjunct to suspicious mammography results
to help reduce the number of avoidable biopsies.
If the training and optimization study results
confirm the findings presented at SABCS, an algorithm validation
study of up to 500 patients, followed by a separate clinical
validation study in OncoCyte’s CLIA lab, would need to be
successfully completed prior to commercial launch.
Lung Cancer Diagnostic Test
Development
OncoCyte continues to conduct a 300-patient
study of its lung cancer test and now expects to complete the
analysis by the end of the first quarter of 2017, which is up to a
quarter later than its original target date. The delay is
primarily due to the slowing of sample collection during the
holiday period and the uncontrollable randomization rate of
collecting malignant tumor versus benign samples. OncoCyte
has collected all of the necessary benign samples and presently
expects that by the end of January it will receive the additional 7
to 14 malignant samples needed to complete the study.
OncoCyte’s study is utilizing approximately 300
samples being collected from 38 oncology centers in the United
States to finalize the product’s prediction algorithm and to test
its accuracy. All of the samples will be focused specifically on
patients with nodule sizes from 5 to 30 millimeters, the intended
use population for the test.
In December, OncoCyte completed a market
research study of 180 physicians which, combined with a health
economic outcomes study, leads the Company to believe that a
successful confirmatory lung cancer test must have a sensitivity of
at least 85% and a specificity of at least 30%. OncoCyte’s
ongoing 300-patient study is a follow-on study to the Wistar
Institute study, which reported a test sensitivity of 90% and
specificity of 62% at the CHEST 2016 Annual Meeting. If
OncoCyte’s 300-patient study achieves either the range specified by
physicians or duplicates previous studies, OncoCyte may have the
first commercial blood test that can help physicians to better
manage patients presenting with lung nodules to determine which
ones should be biopsied and which ones should continue with regular
non-invasive monitoring, thereby helping to avoid unnecessary lung
biopsies.
As well as continuing the 300 patient study,
OncoCyte is also progressing with work in the three other areas
involved in bringing a diagnostic test to market – product or
operational development, the CLIA lab where patient samples are
analyzed, and commercialization. For example, in the product
development area OncoCyte is focused on finalizing the test’s
specific algorithms used to determine sensitivity and specificity
as well as working closely with its suppliers to optimize reagent
and system parameters and metrics to ensure consistent, reliable
results from the third party equipment and reagents being used to
analyze samples.
As these operational processes are being
established and verified, the Company must complete several steps
to obtain CLIA certification. OncoCyte’s CLIA lab is now
operational, the lab equipment has been qualified for clinical use,
and the lab is fully staffed with a board certified Clinical
Laboratory Director, a clinical supervisor and a licensed
technologist. This team is currently being trained in OncoCyte’s
lung product testing methodology, and a Director of Quality
Assurance has recently been hired. OncoCyte expects to apply for
CLIA certification of the lab following the completion of its
current lung cancer study. Upon CLIA certification OncoCyte will
carry out a CLIA validation study using the finalized processing
algorithm and operational procedures on a new set of at least 300
blinded samples.
On the commercialization planning front,
OncoCyte has ramped up several of the marketing and market access
functions required for a launch of the lung cancer diagnostic test
and expects to be making key medical affairs and sales hires if the
outcome of the current lung cancer study is favorable. OncoCyte has
also begun planning the implementation of the commercial systems
and infrastructure necessary for launch, including customer
relationship management, billing, fulfillment, and reporting
processes and systems.
If the steps described above are successful, a
commercial launch of the test could occur in the second half of
2017.
Bladder Cancer Diagnostic Test
Development
In June 2016 at ASCO (the American Society of
Clinical Oncologists), OncoCyte presented the results of a 241
patient study that demonstrated the feasibility of OncoCyte’s
non-invasive, urine-based test to detect bladder cancer and to
distinguish between high-grade and low-grade cancers. The test for
the detection of high-grade urothelial carcinoma in patients
presenting with hematuria performed with an AUC of 0.93, while for
low-grade performed with an AUC of 0.81. Commercializing a bladder
cancer diagnostic test would require a much larger salesforce than
would be required to commercialize either the lung or breast cancer
tests. Therefore OncoCyte continues to examine strategies,
including partnering the product, to fund late stage development
and commercialization of the bladder cancer test.
About OncoCyte
CorporationOncoCyte 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, bladder and breast
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 and other patient
sample studies or regulatory approvals, reliability of third party
reagents and equipment, 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
Media Contact
Tom Gibson
201-476-0322