Full Press Release Details
Announces Initial Results of DetermaVu Feasibility on New Platforms; Enhancements May Increase Lung Cancer Diagnostic Test's
Clinical Performance
Anticipates Commercial Launch During 2018
Calif. - March 8, 2018 - OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive liquid
biopsy tests for the early detection of cancer, today provided an update on the development and commercial launch timeline of
DetermaVu , its liquid biopsy lung cancer diagnostic test.
reported in November 2017, during the process of running initial samples for the Clinical Validation Study inconsistent analytic
results were observed by OncoCyte's technical team. OncoCyte determined that this was caused by a variance in the lots of
consumables used in the sample-processing system that analyzes blood samples for markers that may indicate whether lung nodules
found in patients are benign or suspicious. OncoCyte has been actively engaged with NanoString to more completely understand the
issues that have delayed the DetermaVu validation study. The work with NanoString is ongoing. The work to date continues
to support OncoCyte's conclusion that the previous studies of DetermaVu were not impacted by this consumables issue
and the positive results reported previously have not changed.
addition to assessing the NanoString platform's commercial applicability, OncoCyte is actively evaluating alternative assay
platforms for use with its molecular biology diagnostic testing. OncoCyte is announcing the encouraging initial results of its
initial clinical sample feasibility study on the Illumina Sequencing platform. The Illumina platform is a market-leading platform
for molecular biology testing in the clinical Laboratory Developed Test (LDT) space. While further testing is needed, OncoCyte's
initial results indicate that the Illumina platform could provide consistent and robust support for the further clinical development
studies that are necessary for the commercialization of DetermaVu .
Hesterberg, OncoCyte's Senior Vice President of Research and Development, stated, "The initial feasibility results
on an established clinical platform may provide OncoCyte with an alternative path to clinical validation and commercial launch
of the DetermaVu product in 2018. We will be pursuing the next steps to further assess the Illumina platform, along with
other commercially established clinical molecular testing platforms, and we are encouraged by the results of this initial feasibility
has also identified ways that potentially may enhance the lung cancer signal identified by DetermaVu and has incorporated
this approach into a revised algorithm. This revised algorithm was tested on about 60 clinical samples and resulted in accuracy
(as measured by Area Under the Curve (AUC) data) equivalent or superior to previously reported results, although the error bar
or potential range of results from this small sample set is wide and the results must be confirmed in a larger sample set.
of these developments, OncoCyte is extending its evaluation of the commercial molecular diagnostic platforms by doing a follow-on
study utilizing a larger set of clinical samples. The Company expects to complete the process during the second quarter of 2018.
After concluding this process, data will be available to determine which platform delivers the most accurate, consistent and robust
test results while maintaining a reasonable cost of goods. The Company then intends to complete product development on the selected
platform by carrying out an R&D Validation Study followed by an Analytical Validation Study. If these studies are successfully
completed, OncoCyte intends to conduct a Clinical Validation Study. Clinical validation is the final step prior to commercial
launch, which is still anticipated during 2018. OncoCyte has collected all the samples necessary for carrying out all these studies.
results from our recent evaluation of commercially available molecular testing platforms support our continued confidence in DetermaVu
as a confirmatory test for the diagnosis of early stage lung cancer," commented William Annett, President and Chief Executive
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.
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 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.
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.
Haines / Michael Polyviou