Can a liquid biopsy test be accurate enough for physicians to rely on in differentiating between malignant and benign lung nodules
in early stage lung cancer and probably other cancers?
A Yes answer has come out from OncoCyte Corporation (OCX) which announced positive results from its key R&D Validation study demonstrating the accuracy of the Company’s DetermaVu™ liquid biopsy test for lung cancer. The R&D Validation study has demonstrated a sensitivity of 90% and specificity of 75% of DetermaVu™ on 250 patient blood samples that were blinded to laboratory operators.
Sensitivity is the percentage of malignant nodules that are correctly identified and specificity is the percentage of benign nodules correctly identified. A 95% confidence interval (CI) suggests that there is a 95% chance that final test performance will be within the stated range.
The R&D Validation study utilized the optimized bio-markers and algorithm that were previously identified in the company’s recently completed Algorithm Development study, based on 700 patient samples.
According to the firm’s press release, the results show that DetermaVu™ significantly exceeds the critical parameters necessary for use in lung cancer diagnosis and that DetermaVu™ clearly outperforms reported results from competitors’ tests and other clinical models.
OncoCyte believes that DetermaVu™ is the best-in-class lung cancer liquid biopsy diagnostic test and plans to make this test commercially available in the second half of 2019. The firm’s goal is to fundamentally change the way lung cancer is diagnosed.
Good news in favor of the DetermaVu™ is that unlike liquid biopsy, lung cancer tests developed by other companies using clinical data points, such as lung nodule size, to help the diagnosis. Oncocyte’s DetermaVu™ ™ test demonstrated its superior accuracy results without any help with clinical factors. This advantage reinforces DetermaVu™ ‘s strength as a differential diagnostic tool for early lung cancer detection and provides physicians with significant biologic information that has not been made available prior to DetermaVu™ .
The DetermaVu™ liquid biopsy measures bio-markers of the immune system’s response to cancer to differentiate between malignant and benign lung nodules in early stage lung cancer.
How DetermaVu™ will be used by physicians:
According to OncoCyte’s press release, physicians could use a simple DetermaVu™ blood test to determine whether or not a patient’s lung nodule should be biopsied for cancer. If the DetermaVu™ test indicates a benign result, the patient can be monitored without a biopsy, eliminating the cost and safety risks of an invasive procedure. With 75% specificity, physicians could use DetermaVu™ to eliminate up to three quarters of unnecessary biopsies and their associated complications and deaths.
A Substantial Reduction of healthcare cost
According to Oncocyte’s press release, DetermaVu™ has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year through eliminating unnecessary biopsies, which according to a recent Medicare study, cost on average $14,634 each.
The press release added that DetermaVu™ can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures and deaths that occur in up to 1% of cases. These reduced costs and improved patient outcomes highlight DetermaVu™’s value proposition for payers such as Medicare and health insurance companies.
R&D Validation Study Highlights:
DetermaVu™ demonstrated sensitivity of 90% and specificity of 75% (95% CI 68%-81%) in a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators and without the use of clinical factors such as nodule size.
Results are the first ever in a blinded prospective study to confirm OncoCyte’s approach of utilizing the immune system’s response to early stage cancer to provide a robust biological signal in blood that supports physicians in differentiating between malignant and benign lung nodules
The results are consistent with previous studies of DetermaVu™, even though this study achieved statistically equivalent results using bio-markers alone without the use of clinical factors such as nodule size, further confirming the strength and robustness of the bio-markers in the assay.
The company’s immune system interrogation approach overcomes significant challenges and limitations associated with early stage lung cancer detection using other liquid biopsy approaches, such as circulating tumor cell and cell free DNA detection, which have failed to demonstrate sensitivity and specificity characteristics comparable to DetermaVu™, particularly in early stage lung cancer patients
Lyndal Hesterberg, Ph.D., Senior Vice President of Research and Development of OncoCyte, stated, “These results serve to validate OncoCyte’s immune system interrogation approach and are a significant scientific advancement in the field of liquid biopsy with three main achievements: First, we have demonstrated that the biological basis for DetermaVu™, that is, gene expression changes within the immune system in response to cancer, can serve as a highly sensitive and accurate signal in blood for early stage lung cancer diagnosis. Second, we have shown for the first time in a prospective cohort of blinded samples, and without the use of any clinical factors, that DetermaVu™ has the sensitivity and specificity required for clinical use.”
Dr. Hesterberg added, “Finally, we believe that our approach, using a liquid biopsy to leverage the exquisite sensitivity of the body’s immune response to cancer, might have broad application in detecting other early stage malignancies. We are planning to investigate the use of this unique immune system interrogation approach in other cancer types.”
William Annett, President and Chief Executive Officer of OncoCyte, said, “We believe DetermaVu™ is poised to establish a new paradigm for diagnosing individuals at risk of lung cancer while addressing a multibillion-dollar market opportunity. Physicians need better tools to diagnose malignant versus benign lung nodules in order to reduce the large number of unnecessary lung biopsies that create risks for patients and are costly to the healthcare system. The successful completion of our prospective cohort, blinded R&D Validation study confirms that DetermaVu™ significantly exceeds the key criteria essential for a viable commercial product. We are thrilled by these findings and are proceeding quickly with our commercial planning, with the goal of making DetermaVu™ commercially available in the second half of 2019.”
Remaining DetermaVu™ Development Steps Required
Having achieved successful R&D Validation utilizing the robust and reproducible Thermo Fisher Ion GeneStudio S5 next-generation sequencing platform, OncoCyte is working to complete the remaining steps to make DetermaVu™ commercially available in the second half of this year: Analytical Validation, CLIA Validation and Clinical Validation.
These steps may be completed in rapid succession because the Company has all the necessary patient samples in-house. The Analytical Validation study is designed to establish performance characteristics of the assay system, which will then be validated in the Company’s CLIA-certified laboratory in Alameda California.
As the final laboratory step, prior to DetermaVu™ commercialization, OncoCyte will initiate a Clinical Validation study in its CLIA lab, which will analyze approximately 350 blinded, prospectively-collected, patient samples for final confirmation of test sensitivity and specificity.
Conference Call and Webcast Details: OncoCyte’s management team has conducted a live conference call and webcast today at 8:30 a.m. EST. The webcast replay will be on the firm’s website at www.oncocyte.com approximately 2 hours following completion of the call.
A successful liquid biopsy is one of the most hopeful outcome of the genomic and immunology revolutions which are changing and improving the diagnosis and treatment of diseases. A successful liquid biopsy would bring with it many improvements; starting with eliminating unnecessary invasive procedures that would impact patients’ safety while costing exorbitant amounts of money. Investors received the news with great enthusiasm as demonstrated in OncoCyte’s stock, which is now trading at $5.88 UP $4.06. That’s 223.08%.