– 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
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.
The 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.
In 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 factor.
The 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.
This 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.
“We 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.
Lyndal 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.”
While 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.
OncoCyte 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.
With 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.
OncoCyte 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.
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