QURE Healthcare

The clinical utility studies planned with the two partners will evaluate the impact of the PDAC assay in enhancing patient outcomes, improving healthcare economics, and delivering benefits for clinicians Biological Dynamics has partnered with QURE and Curta to study the effects of early identification of the cancer in high-risk cohorts with its PDAC assay. (Credit: valelopardo from Pixabay) Biological Dynamics is partnering with QURE Healthcare and Curta to assess its assay in the early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk cohorts. The US-based exosome-isolation technology and early disease detection diagnostic firm said that the clinical utility studies with the two partners will evaluate the impact of its PDAC assay in enhancing patient outcomes, improving healthcare economics, and demonstrating benefits for clinicians. Biological Dynamics announced independent studies to better understand how providers will use its early PDAC detection assay. The test performance and cost related to subsequent patient care and curative interventions that payors evaluate for reimbursement decisions will also be analysed, the firm added. Biological Dynamics CEO and director Paul Billings said: “We believe our technology ventures well beyond the DNA-based sequencing tests available for PDAC to the serial imaging that has been the standard for detecting pancreatic cancer for decades. “We must more fully understand the risks and benefits of early detection methods in all individuals including those at high-risk for pancreatic cancer. “These two studies will add important observations as we evolve to better management of disease risk and sensitive diagnoses.” Curta is engaged in developing models to demonstrate how new medical technologies may affect actual care and results. Biological Dynamics said that the Curta study will examine the potential economic and health effects of early PDAC identification using its PDAC assay. Curta senior partner and CMO Scott Ramsey said: “A blood test is much easier to administer for patients compared to a battery of imaging technologies. It can make clinical flow easier by saving unnecessary tests when the PDAC assay is negative. “Our modelling will characterise the current standard of care for surveillance of patients with high risk for pancreatic cancer.” According to Biological Dynamics, QURE Healthcare measures physicians’ clinical practice patterns to understand how new technology may impact patient care. The Clinical Performance and Value (CPV) patient simulations used in the QURE study will be used in a randomised controlled trial to see whether adopting the PDAC assay would change physician behaviour, the company added.

The company partners with QURE and Curta to assess value of early identification in high-risk cohorts SAN DIEGO, Nov. 22, 2022 /PRNewswire/ -- Biological Dynamics, an exosome-isolation technology and early disease detection diagnostic company, today announced that it has partnered with both QURE Healthcare and Curta to explore how the company's assay for early detection of pancreatic ductal adenocarcinoma (PDAC) can improve patient outcomes, demonstrate the greatest value to clinicians, and enhance healthcare economics. Earlier PDAC detection has the potential to improve the survival and quality of life for high-risk patients. However, there is a need to understand physician adoption to enhance clinical decisions affecting treatment, patient outcomes, and the use of finite healthcare resources. Therefore, Biological Dynamics will help conduct independent studies on how providers will use its early PDAC detection assay and how the test performance and cost may impact downstream patient care and curative interventions that payors review for reimbursement coverage decisions. "We believe our technology ventures well beyond the DNA-based sequencing tests available for PDAC to the serial imaging that has been the standard for detecting pancreatic cancer for decades," said Paul R. Billings, M.D., Ph.D., F.A.C.P., F.A.C.M.G.G., CEO and Director of Biological Dynamics. "We must more fully understand the risks and benefits of early detection methods in all individuals including those at high-risk for pancreatic cancer. These two studies will add important observations as we evolve to better management of disease risk and sensitive diagnoses." Curta develops models that characterize how new health technologies can influence care and outcomes in the real world. The Curta study for Biological Dynamics will explore the potential health and economic outcomes of early PDAC detection with the Biological Dynamics' PDAC assay from a US payor perspective. It is hypothesized that shifting diagnoses from regional and distant stages to the localized stage in high-risk adults will result in improved survival and quality of life. "A blood test is much easier to administer for patients compared to a battery of imaging technologies. It can make clinical flow easier by saving unnecessary tests when the PDAC assay is negative," said Scott D. Ramsey, M.D, Ph.D., Senior Partner and CMO at Curta. Dr. Ramsey went on to say "Our modeling will characterize the current standard of care for surveillance of patients with high risk for pancreatic cancer. Our model will provide scenarios where the assay can improve guideline adherence, potentially reducing costs and improving outcomes — and put this evidence into a framework that payors will understand. Ultimately, we are hopeful it will improve the state of evidence supporting future guidelines." QURE Healthcare measures clinical practice patterns among physicians to understand how new technologies will affect patient care. The QURE study for Biological Dynamics will investigate if use of the company's PDAC assay would alter physician behavior using a randomized controlled trial with QURE's Clinical Performance and Value (CPV®) patient simulations. "The study will provide evidence-based outcomes to determine if the assay will change clinical decisions when managing patients at high risk for PDAC as well as those presenting with symptoms of possible pancreatic cancer," said John Peabody, M.D., Ph.D., FACP President of QURE Healthcare and Professor at the University of California, San Francisco. "This is an enormously complicated area with a paucity of evidence around guidelines and preventive care. We are enrolling physicians now in a randomized controlled trial so that we can uniquely determine if this leads to an earlier evaluation. We are excited about the assay and its potential to dramatically change medicine," Dr. Peabody continued. About Biological Dynamics Biological Dynamics, Inc. is committed to improving global health outcomes by detecting diseases at the earliest stages. The company's proprietary ExoVerita™ platform simplifies isolation of extracellular vesicles, enabling multiomic applications. In 2021, the U.S. Food and Drug Administration granted Breakthrough Device Designation for its PDAC assay, for early detection of the aggressive and lethal pancreatic ductal adenocarcinoma in high-risk populations. Its AACC award-winning PDAC assay operates in a College of American Pathologists (CAP) accredited, CLIA-certified clinical laboratory in San Diego. For more information visit or LinkedIn. CONTACT: Kellee Johnson 312-751-3959 [email protected] SOURCE Biological Dynamics

Data presented during the 30th United European Gastroenterology (UEG) Week in Vienna, Austria FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data from a randomized controlled trial (RCT) showing that use of TissueCypher® Barrett’s Esophagus Test results can significantly improve a physician’s accuracy in assessing the risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in patients diagnosed with Barrett’s esophagus (BE), as well as adherence to guideline-recommended patient management strategies. EAC is an aggressive form of esophageal cancer associated with poor outcomes, and the only known precursor condition to its development is BE. TissueCypher is Castle’s precision medicine test designed to predict progression to HGD and/or EAC within five years for patients diagnosed with BE. “The study data showed that participants who ordered or received TissueCypher test results were up to 65.6% more likely to predict progression to HGD or EAC, (p<0.001), when compared to physicians who did not receive TissueCypher test results in our randomized trial,” noted John W. Peabody, M.D., Ph.D., first study author and President of QURE Healthcare. “Importantly, subsequent to receiving test results and making their assessment, the intervention group was also more likely to adhere to guideline-recommended management strategies.” These and other results of the RCT were presented through a moderated poster presentation, titled “Results from a randomized controlled trial: introducing a precision medicine diagnostic tool increases adherence to guidelines in patients with Barrett’s esophagus,” shared during the 30th United European Gastroenterology (UEG) Week. The poster may be viewed here. In the RCT, 259 physicians were randomized to three groups and asked to evaluate clinical performance and value (CPV) vignettes with high- and low-risk patient scenarios based on clinical risk factors. A quality-of-care percentage (0-100%) score was generated from the CPVs based on the American College of Gastroenterology (ACG) and the American Society of Gastrointestinal Endoscopy (ASGE) guidelines. Quality-of-care scores improved significantly across all patient cases after physicians were given the TissueCypher test results. “Barrett’s esophagus remains a persistent and real-world clinical challenge for endoscopists and patients. Individuals with non-dysplastic Barrett’s esophagus constitute the vast majority of cases, and for years, we have seen few updates in the management strategy of this patient population in particular,” said Craig Munroe, M.D., gastroenterology medical director at Castle Biosciences. “We were very excited to present the results of the QURE study, which help further demonstrate TissueCypher's potential to meaningfully advance the care of this important patient population. We believe the clinical utility and objective information provided by our test can equip physicians with the information they need to make more informed treatment plan decisions and move beyond the limitations in the current standard of care for risk stratification of patients with BE.” About TissueCypher® Barrett’s Esophagus Test The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). TissueCypher is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (ND), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by nine peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U) and has been on the Medicare Clinical Laboratory Fee Schedule since January 2021. Additionally, the test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022. About Castle Biosciences Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions. To learn more, please visit and connect with us on LinkedIn, Facebook, Twitter and Instagram. DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: TissueCypher’s potential to meaningfully advance the care of patients diagnosed with BE and significantly improve a physician’s accuracy in assessing the risk of progression in patients diagnosed with BE, as well as adherence to guideline-recommended patient management strategies; and our belief that the clinical utility and objective information provided by TissueCypher can guide patient care in an area of significant unmet clinical need and equip physicians with the information they need to make more informed treatment plan decisions and move beyond the limitations in the current standard of care. The words “believe,” “can,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in this study, including with respect to the discussion of TissueCypher in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2022, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.