Big Barnie
5 years ago
Oncocyte Announces Peer-Reviewed Publication of Data Demonstrating the Potential of its TNBCType Assay to Inform Triple Negative Breast Cancer Drug Development
Peer reviewed research demonstrates the utility of the Oncocyte’s TNBCType-IM assay to identify the most suitable cell lines to help biopharma and academic researchers in their quest for treatments for TNBC, the deadliest form of breast cancer
Published research demonstrates the test’s ability to work consistently both in vitro and in vivo in six cell lines used in drug development, suggesting promise in research applications
IRVINE, Calif., May 05, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced the peer-reviewed publication of data underscoring the potential of its TNBCType assay for use in triple negative breast cancer (TNBC) pharmaceutical research. The paper, entitled “Identification of triple-negative breast cancer cell lines classified under the same molecular subtype using different molecular characterization techniques: implications for translational research”, was written by collaborators at The University of Texas MD Anderson Cancer Center and demonstrates the ability of the assay to work consistently across six cell lines typically used in drug development, both in vivo and in vitro. The findings were published in the peer-reviewed journal PLOS One.
Breast cancer is the most common cancer with more than 1.6 million new cases diagnosed annually in the world. In the United States, the overall 5-Year survival rates in breast cancer are over 90%, but survival rates for triple negative breast cancer (TNBC) are lower at 77%. TNBC is generally more aggressive than other types of breast cancer and is the focus of intense research by biopharmaceutical companies with over 100 clinical trials and several discovery-phase programs in process. TNBCType-IM is a 101 gene assay that measures the amount of RNA from a biopsy or surgical specimen and then uses a proprietary algorithm to classify patients into five subtypes associated with response to four different types of therapeutics including immune-therapy (PD-1/PD-L1), targeted therapies (PARP inhibitors and AR receptor) and cytotoxic chemotherapy. The Company believes that the assay may be an attractive companion diagnostic candidate for proprietary therapeutics in development at biopharmaceutical companies.
In the study, researchers established tumor xenografts from 17 TNBC cell lines that were then subjected to gene expression profiling with a 2188-gene algorithm, TNBCType, and Oncocyte’s revised 101-gene algorithm TNBCtype-IM. A total of six cell lines were identified as maintaining consistent subtype classification between in vitro and in vivo tumor xenograft analyses by Oncocyte’s TNBCtype-IM algorithm, suggesting they may be the optimal cell lines for use in subtype specific TNBC drug development and translational research.
Naoto Ueno, M.D., Ph.D., Professor of Breast Medical Oncology at MD Anderson Cancer Center and the lead author of the study, said, "In developing new therapies for TNBC, it is important to have cell lines that are stable both in vitro and in vivo to show the drug’s effectiveness. This research will help pharma and academic researchers know which cell lines to use to identify the most promising therapeutic candidates to personalize the cancer treatment in TNBC."
“The data published in this manuscript reinforce the potential clinical importance of TNBC classification,” added Doug Ross, M.D., Ph.D., Chief Medical Officer of Oncocyte. “This information will help bridge the gap between drug development and the potential use of TNBCtype for making clinical decisions.”
About Oncocyte Corporation
Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. DetermaDx™, the company’s liquid biopsy test in development, utilizes a proprietary immune system interrogation approach to clarify if a patients’ lung nodules are benign, which may enable them to avoid potentially risky invasive diagnostic procedures. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies.
DetermaDx, DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.
Big Barnie
5 years ago
Oncocyte Announces Final Medicare LCD from Palmetto for DetermaRx™
May lead to Medicare coverage for up to 70% of eligible early-stage lung cancer patients
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April 30, 2020 14:21 ET | Source: OncoCyte Corporation
IRVINE, Calif., April 30, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that Palmetto, the Medicare Administrative Contractor for the Centers for Medicare & Medicaid Services (CMS), has issued a final local coverage decision for DetermaRx™. The test, which launched earlier this year via an early access program, is the first and only predictive test for the identification of patients with Stage I-IIA non-squamous NSCLC who are at high-risk for recurrence following surgery and are likely responsive to adjuvant chemotherapy.
“Today’s CMS decision is a significant milestone for Oncocyte. Not only can we now increase outreach to more patients and physicians around the country, but we believe several national and regional payers will follow this decision, giving additional patients insurance coverage for this important test,” said Ron Andrews, CEO of Oncocyte. “The DetermaRx test addresses a critical unmet need for the 30-50% of patients with early-stage lung cancer who have a recurrence despite having “curative” surgery. In a published clinical study, patients identified as high-risk by the DetermaRx test post-surgery and treated by chemotherapy had survival rate of 92% compared to high-risk untreated patients who had a survival rate of 49%.”
“Despite the impact of COVID-19, we have seen significant interest in this test just in the first quarter of launch, with twenty onboarded sites and more than 1500 attendees to physician education programs. Today’s CMS decision further supports the promise of DetermaRx, and we are looking forward to expanding our reach throughout the U.S. over the coming months.”
Following this decision, Oncocyte intends to intensify its efforts with private payers who have a history of following Medicare coverage decisions, with the goal of securing coverage for patients with private insurance.
Please visit CMS.gov to view the final local coverage decision memo.
About Oncocyte Corporation
Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. DetermaDx™, the company’s liquid biopsy test in development, utilizes a proprietary immune system interrogation approach to clarify if a patients’ lung nodules are benign, which may enable them to avoid potentially risky invasive diagnostic procedures. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies. DetermaDx, DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.
Big Barnie
5 years ago
Oncocyte Announces Distribution Agreement with CORE Diagnostics, Expanding Commercial Availability of DetermaRx™ to India, the Middle East and Africa
In the United States, DetermaRx™ has rapidly gained traction, expanding to 18 sites in the first three months since commercial launch
IRVINE, Calif., April 23, 2020 (GLOBE NEWSWIRE) -- Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that it has entered a distribution agreement with CORE Diagnostics, expanding the commercial availability of DetermaRx™ to India, the Middle East and Africa. DetermaRx™ is Oncocyte’s treatment stratification test that identifies patients at high risk for lung cancer recurrence, who may benefit from adjuvant chemotherapy post-surgery.
CORE Diagnostics is one of the fastest-growing clinical laboratories in India, focused on bringing the most advanced testing techniques and expertise to the country. Under the terms of the agreement, tissue samples needed for the test will be run in the United States by Oncocyte, while CORE Diagnostics will generate test orders and provide customer service to patients.
“As we think about expanding beyond the U.S., one of our strategies is to partner with labs focused on delivering high value, proprietary diagnostics into an existing oncology channel to generate demand and brand awareness. CORE Diagnostics does exactly that,” said Ron Andrews, Chief Executive Officer of Oncocyte. “We believe CORE’s oncology salesforce of 100 people and customer base of 5000 ordering physicians in 12 different countries will be critical as we work to increase awareness and availability of our tests among physicians and patients globally. We are thrilled to embark on this collaboration with such a respected and growing brand in this important market and are looking forward to tens of thousands more patients having access to our tests, potentially saving lives in the process. As we continue to grow, we intend to extend this distribution model to other geographies including South America and other parts of Asia as well.”
Zoya Brar, Chief Executive Officer and Founder of CORE Diagnostics added, “The market for molecular testing in India and the Middle East is quite large. We focus on partnering with labs that offer proprietary diagnostics fulfilling an unmet need at a patient friendly price for our population, and we believe DetermaRx perfectly fits these characteristics. We look forward to making this test and potentially other diagnostic tests from Oncocyte available across these countries in the future.”
DetermaRx was launched in the United States through an Early Access Program (EAP) in late January 2020 with two sites. Since then it has continued to gain traction, rapidly expanding to eighteen sites in just the first three months of launch. These targeted sites are located across the country including multiple community cancer centers where early stage cancer is managed including physicians from large community-based systems, such as Dignity Health and Northshore Oncology. The Company has onboarded eight sites in the past month despite COVID-19 challenges throughout the country. Oncocyte will begin serving physicians in these sites once surgeries for early stage lung cancer ramp back up over the coming months.
“We’re thrilled with the progress made thus far to expand the availability of DetermaRx, both in the U.S. and beyond,” said Padma Sundar, Senior Vice President, Marketing and Market Access at Oncocyte. “I’m incredibly proud of our team’s rapid pivot to virtual operations as the COVID-19 situation began to progress and am confident that the quick expansion in DetermaRx test adoption sites was driven by this foresight. Our online peer-to-peer physician engagement initiatives have reached over 1500 participants. Additionally, we’ve seen success with virtual onboarding of sites using sophisticated physician office-friendly software for easy test ordering, processing and delivery of test reports, as well as prompt customer service. We intend to take these same steps to ensure similar expansion outside of the U.S. and are looking forward to continued progress.”
About Oncocyte Corporation
Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The Company recently launched DetermaRx™, a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence post-resection, allowing them to be treated when their cancer may be more responsive to adjuvant chemotherapy. DetermaDx™, the company’s liquid biopsy test in development, utilizes a proprietary immune system interrogation approach to clarify if a patients’ lung nodules are benign, which may enable them to avoid potentially risky invasive diagnostic procedures. Oncocyte is also developing DetermaIO™, a gene expression test that identifies patients more likely to respond to checkpoint immunotherapies.
DetermaDx, DetermaRx and DetermaIO are trademarks of Oncocyte Corporation.
DMOST
5 years ago
OncoCyte to Present Data From a Study Examining Its Liquid Biopsy Test During the CHEST Annual Meeting 2019
GlobeNewswire•October 15, 2019
ALAMEDA, Calif., Oct. 15, 2019 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE American: OCX), a molecular diagnostics company providing actionable answers at critical decision points across the cancer care continuum, today announced the company will present data highlighting its proprietary liquid biopsy test, which has the potential to determine which nodules are benign to reduce the number of unnecessary biopsies and associated complications, during the CHEST Annual Meeting 2019. This year’s CHEST meeting is being held October 19-23, 2019 at the Ernest N. Morial Convention Center in New Orleans, LA.
Details of the poster discussion are as follows:
Poster #: E1101
Title: The Immune Response for Nodule Evaluation (IRENE) Cohort Profile
Presenter: Lyndal Hesterberg, Ph.D.
Date: Wednesday, October 23, 2019
Time: 10:15 a.m. – 10:20 a.m. CDT
About OncoCyte Corporation
OncoCyte is a molecular diagnostics company providing actionable answers at critical decision points across the lung cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment. The company is currently developing a treatment stratification test that enables the identification of early-stage lung cancer patients at high risk for recurrence, allowing them to be treated when their cancer is still responsive to adjuvant chemotherapy. DetermaVu, the company’s liquid biopsy test in development, utilizes a proprietary immune system interrogation approach to clarify which patients’ lung nodules are benign, enabling them to avoid potentially risky biopsy procedures.
OncoCyte Forward Looking Statements
Any 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 time to complete and the results of OncoCyte’s ongoing CLIA Validation study of DetermaVu™, the closing of our planned acquisition of Razor and the Razor test, 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, 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 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, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. OncoCyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Investor Contacts
Bob Yedid
LifeSci Advisors, LLC
646-597-6989
bob@lifesciadvisors.com
Media Contact
Andrew Mielach
LifeSci Public Relations, LLC
646-876-5868
amielach@lifescipublicrelations.com
'peace'
DMOST
5 years ago
OncoCyte to Report Second Quarter 2019 Financial Results on Wednesday, August 14, 2019
LAMEDA, Calif., July 31, 2019 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, announced today that it will release its financial and operating results for the second quarter ended June 30, 2019, on Wednesday, August 14, 2019, after the close of the U.S. financial markets. The Company will host a conference call on Wednesday, August 14, 2019, at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate developments.
The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13692586. To access the live webcast, go to the investor relations section on the Company’s website, http://public.viavid.com/index.php?id=135362.
About OncoCyte Corporation
OncoCyte is focused on the development and commercialization of novel, diagnostic tests for the early detection and management of cancer, when it is most curable. OncoCyte has developed a proprietary liquid biopsy that can assess the immune system’s response to cancer at its earliest stages. The first application of this liquid biopsy is a blood test in development to aid in the diagnosis of lung cancer and reduce the need for risky and costly diagnostic procedures such as invasive lung biopsies.
Contact
Bob Yedid
LifeSci Advisors, LLC
bob@lifesciadvisors.com
646-597-6989
Source: OncoCyte Corporation
https://finance.yahoo.com/news/oncocyte-report-second-quarter-2019-120000848.html
GO OCX
"PEACE"
DMOST
5 years ago
OncoCyte Presents Positive Results from R&D Validation Study of DetermaVu™ at the American Thoracic Society 2019 International Conference
GlobeNewswire•May 21, 2019
Results were achieved using blood gene expression biomarkers alone and without the use of clinical parameters
Company remains on-track to make DetermaVu™ commercially available in 2H 2019
ALAMEDA, Calif., May 21, 2019 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, today presented results from the Company’s R&D Validation study at the American Thoracic Society (ATS) 2019 International Conference, which is being held May 17 to May 22 in Dallas. The poster details the compelling results from the Company’s successful R&D Validation study of DetermaVu™, OncoCyte’s liquid biopsy test for the early detection of lung cancer.
The R&D Validation study demonstrated a sensitivity of 90% (95% confidence interval from 82%-95%) and specificity of 75% (95% confidence interval from 68%-81%) of DetermaVu™ on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators.
“We are very pleased to present for the first time the strong findings from our R&D Validation study of DetermaVu™ at this year’s ATS meeting. We believe these results are poised to redefine the paradigm in lung cancer detection,” said Lyndal Hesterberg, Chief Scientific Officer of OncoCyte. “Most notably, we were able to achieve these results using gene-expression biomarkers alone and without the use of clinical parameters such as nodule size that are solely employed by the Mayo model and other algorithm models currently used to estimate the probability of cancer in patients with pulmonary nodules. Our unique Immune System Interrogation approach can potentially detect lung cancer in earlier stages of the disease when more favorable patient outcomes are feasible. We are excited about the potential of this novel test to positively impact the lives of patients globally, and are rapidly advancing through remaining development studies as we work to make DetermaVu™ commercially available in the second half of this year.”
Summary results:
A multivariate gene expression classifier was used to identify benign from malignant nodules between 5-30mm with a high degree of accuracy in a diverse population of current and former smokers
Using only gene-expression biomarkers from whole blood, and with no clinical parameters, the DetermaVu™ test yielded an overall Area Under the Curve (AUC) of 0.89 with Sensitivity ~90% (95% confidence interval of 82%-95%) and Specificity ~75% (95% confidence interval of 68%-81%)
This classifier significantly outperformed the Mayo algorithm model for cancer risk that utilizes only clinical factors such as nodule size
Poster details:
Session:
110 - THE FUTURE OF LUNG CANCER BIOMARKERS: WHERE SHOULD WE LOOK?
RAPiD: Rapid Abstract Poster Discussion Session
Day and time: Tuesday, May 21, 2019 - 2:15 - 4:15 PM CDT
Location: Arena (Level 2), KBHCCD
Poster Title: Blinded Prospective Validation Study of a Whole Blood Gene-Expression Classifier
for the Diagnosis of Benign Versus Malignant Pulmonary Nodules
Poster #: 421
Viewing Time: 2:15-2:45 PM CDT
Discussion Time: 2:45-4:15 PM CDT
The poster can be viewed here.
About ATS
The American Thoracic Society improves global health by advancing research, patient care, and public health in pulmonary disease, critical illness, and sleep disorders. Founded in 1905 to combat tuberculosis (TB), the ATS has grown to tackle asthma, COPD, lung cancer, sepsis, acute respiratory distress, and sleep apnea, among other diseases.
About DetermaVu™
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 $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.
DetermaVu™ has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, 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.
DetermaVu™ is a trademark of OncoCyte Corporation
About OncoCyte Corporation
OncoCyte is focused on the development and commercialization of novel, non-invasive blood (“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 procedures. OncoCyte is focusing its efforts on developing DetermaVu™ as a non-invasive confirmatory diagnostic test for lung cancer. DetermaVu™ is being developed using proprietary sets of genetic and protein molecular markers to detect the presence of lung cancer. OncoCyte also plans to conduct research to identify additional molecular markers, acquire or license markers and related technology, and develop cancer tests based on those markers.
OncoCyte Forward Looking Statements
Any 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.
Investor Contacts
Bob Yedid
LifeSci Advisors, LLC
bob@lifesciadvisors.com
646-597-6989
Media Contact
Andrew Mielach
LifeSci Public Relations
amielach@lifescipublicrelations.com
646-876-5868
Contact:
GO OCX
"PEACE"
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