Full Press Release Details
Reports Encouraging New Study Results for Lung Cancer Blood Test
Results suggest improved performance of next-generation test
Study results support move to new diagnostic testing platform
Significant development work required to fully validate this recent progress
Calif., July 9, 2018 - OncoCyte Corporation (NYSE American: OCX), a developer of novel tests for early detection of
cancer, today reported that its most recent study of clinical samples in the development of DetermaVu , its lung cancer
diagnostic blood test, has produced encouraging results. This study supports moving the test to a leading clinical diagnostic
testing platform and indicates that the clinical performance of the test may be better than was previously expected.
move to a leading diagnostic testing platform is expected to resolve the inconsistent data issues OncoCyte encountered with the
diagnostic testing platform it had previously used in the development of DetermaVu . OncoCyte believes that the precision
of Next Generation Sequencing (NGS) platforms may increase test performance. In addition, the use of a NGS platform could allow
for decentralized operations beyond OncoCyte's CLIA lab, potentially enabling development of a CE marked kit product for
distribution in Europe and other markets, if OncoCyte's upcoming studies are successful.
addition, the study incorporated newly discovered biomarkers into a new, next-generation version of DetermaVu . These biomarkers
appear to be more robust than those used in the earlier biomarker panel and may enhance the utility and accuracy of DetermaVu .
The use of the new biomarkers in combination with the existing Wistar biomarkers achieved encouraging results even without the
inclusion of clinical data such as nodule size, while the original DetermaVu algorithm included nodule size as a contributing
study found that an enhanced algorithm incorporating the best-performing new biomarkers with the best-performing biomarkers used
in previous DetermaVu studies yielded accuracy results (as measured by Area Under the Curve (AUC) data) equivalent or superior
to results of previous studies using the earlier biomarker panel and algorithm. Because the error bar or potential range of results
from the small sample set in the study is wide, these results must be confirmed in a larger sample set.
most recent study was performed on two assay platforms, the Illumina Nova Seq 6000 and Thermo Fisher Chef-S5. DetermaVu
ran successfully on both platforms. OncoCyte anticipates that the use of one of these widely commercialized diagnostic platforms
will increase the likelihood that DetermaVu will offer the consistent and robust results necessary for product development and
commercial operations.
are extremely pleased with the results of this study, which provide us with a new diagnostic testing platform and a route forward
for the development of a next-generation DetermaVu ," said William Annett, President and Chief Executive Officer.
Hesterberg, Senior Vice President of Research and Development, stated, "The study results are very encouraging. Although
further studies testing larger numbers of samples are necessary, it appears the addition of the new biomarkers in DetermaVu
may enhance the accuracy of our diagnostic test."
these initial results are very encouraging, significant development work remains. OncoCyte will engage in a series of studies
intended to retrain and validate the algorithm on the new platform. The company will further test its biomarkers on a broader
set of clinical samples, with the goal of selecting the optimal biomarker panel and algorithm.
is currently in the process of moving to the new platform. Next, OncoCyte will perform a prospective, blinded R&D Validation
Study on approximately 250 patients to assess the performance of the algorithm in a blinded set of clinical samples. If successful,
the R&D Validation Study will be followed by an Analytical Validation Study in the Company's CLIA laboratory. Finally,
OncoCyte plans to conduct a Clinical Validation Study to confirm test performance. OncoCyte has collected all the samples it expects
to require for the R&D Validation study.
the necessary samples in hand, OncoCyte has expanded the R&D Validation study protocol to include a larger number of samples
than were used in the comparable 2017 study. This larger sample set is intended to provide OncoCyte with a clearer picture of
the potential accuracy of DetermaVu , and more confidence in the results expected in the Clinical Validation Study that
will follow. OncoCyte's goal is to complete the expanded R&D Validation Study by the end of 2018 and to complete the
Clinical Validation Study during the first half of 2019.
believes that it has the opportunity to create a highly accurate test which, if confirmed in a large clinical data set, could
successfully address what it estimates could be a $4.7 billion annual market in the U.S. for confirmatory lung cancer liquid biopsy
tests, depending on pricing, market penetration, and the availability of Medicare and private payer reimbursements.
is OncoCyte's confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung
cancer diagnosis. DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities
(LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte
estimates that a $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending
on market penetration and reimbursable pricing.
is a trademark of OncoCyte Corporation.
OncoCyte Corporation
is focused on the development and commercialization of novel, non-invasive blood and urine ("liquid biopsy") diagnostic
tests for the early detection of cancer. Early detection of cancer can improve health outcomes, reduce the cost of care, and improve
patients' quality of life. Liquid biopsy diagnostic tests like those OncoCyte is developing may reduce the need for costlier
and riskier diagnostic procedures such as invasive biopsy and cystoscopic procedures. OncoCyte's development pipeline is
focused on non-invasive confirmatory diagnostic tests for lung, breast, and bladder cancer. OncoCyte's tests are being developed
using proprietary sets of genetic and protein molecular markers that differentially express in specific types of cancer. OncoCyte
conducts ongoing research to identify additional molecular markers, acquire or license markers and related technology, and develop
tests based on those markers.
Forward Looking Statements
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 capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a
commercial scale, 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.
Matt Haines / Michael Polyviou
917-733-9297 / 732-933-2754