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Business Wire
16-05-2025
- Business
- Business Wire
Merck to Present New Clinical and Outcomes Research Data at The American Thoracic Society's (ATS) 2025 International Conference Demonstrating Commitment to Advancing Research in Pulmonary Arterial Hypertension
BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new clinical and outcomes research data on pulmonary arterial hypertension (PAH) to be presented at the American Thoracic Society's (ATS) 2025 International Conference in San Francisco from May 16-21. Data from nine presentations demonstrate Merck's commitment to advancing research for patients with this disease. Merck will present pooled data from participants who have completed the PULSAR, SPECTRA, or STELLAR studies and have continued in the ongoing open-label extension study, SOTERIA, evaluating the long-term safety, tolerability and efficacy of WINREVAIR™ (sotatercept-csrk) when added to background therapy for the treatment of PAH. These results represent the largest analysis of WINREVAIR to date. "The results from this pooled analysis add to the growing body of evidence for WINREVAIR,' said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. 'We remain confident in the long-term potential for WINREVAIR for patients with PAH and look forward to sharing findings as we continue to evaluate WINREVAIR." Merck will also present an overall survival analysis for WINREVAIR leveraging data from the pivotal Phase 3 study, STELLAR, and interim data from participants who have continued in the ongoing open-label SOTERIA study, as well as additional outcomes research on the burden and impact of PAH in various patient populations. Details on Merck abstracts at ATS: PAH Long-term safety and exposure-adjusted incidence rates of adverse events from pooled sotatercept studies (PULSAR, SPECTRA, STELLAR, and SOTERIA). I. Preston. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Overall survival of patients on sotatercept: an analysis of STELLAR and SOTERIA trials. T. Thakur. Session B96 Crossing the Golden Gate Bridge: clinical trials, targeted therapies and novel approaches in pulmonary arterial hypertension on Monday, May 19, 5:15 – 7:15 p.m. ET/2:15 – 4:15 p.m. PT Long-term safety of MK-5475 in pulmonary arterial hypertension (PAH): Results from the phase 2 INSIGNIA-PAH extension period. P. Hassoun. Poster Board #505; D28 Fisherman's Wharf: Clinical and epidemiological insights into pulmonary hypertension: trends, treatments, and outcomes on Wednesday, May 21, 11:15 a.m. – 1:15 p.m. ET/8:15 – 10:15 a.m. PT Quantifying the impact of pulmonary arterial hypertension (PAH) on health-related quality of life (HRQOL), work productivity, and economic stability for patients and their caregivers. H. Black. Poster Board #1018; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 –11:15 a.m. PT Comparing the burden of pulmonary arterial hypertension (PAH) among women across regions: a patient survey. T. Thakur. Poster Board #1021; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 – 2:15 p.m. ET/9:15 – 11:15 a.m. PT Perceptions, attitudes and behaviors among women of childbearing and childrearing age with pulmonary arterial hypertension. T. Thakur. Poster Board #1020; B23 Diffuse lung disease and pulmonary hypertension: clinical perspectives on Monday, May 19, 12:15 –2:15 p.m. ET/9:15 – 11:15 a.m. PT The impact of cardiopulmonary comorbidities on the economic burden and mortality of pulmonary arterial hypertension in the United States. H. Black. Poster Board #P253; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Caregiver network and caregiving needs in women with pulmonary arterial hypertension (PAH). T. Thakur. Poster Board #P254; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Acute inpatient utilization among Medicaid patients treated for pulmonary arterial hypertension. A. Watanabe. Poster Board #P251; A36 Pulmonary hypertension patient experience, health services and outcomes on Sunday, May 18, 12:15 – 7:15 p.m. ET/9:15 a.m. – 4:15 p.m. PT Expand About WINREVAIR ™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. Selected Safety Information for WINREVAIR in the U.S. WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required. WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding. WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment. Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility. The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%). Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Patient Information for WINREVAIR at , and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at
Associated Press
18-03-2025
- Business
- Associated Press
Press Release Biocartis NV: Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting
Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting Mechelen, Belgium, 18 March 2025 – Biocartis NV ('Biocartis'), an innovative molecular diagnostics company, is pleased to announce research on the Idylla™ Platform from several renowned institutions at the upcoming United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting, taking place from 22-27 March in Boston, MA, US. Seven abstracts from leading research and academic institutions will be presented as posters, highlighting the rapid, fully automated molecular testing capabilities of the Idylla™ Platform across several different cancer types, including lung cancer1, thyroid cancer2, endometrial carcinoma3 and colorectal cancer4. Biocartis also continues to focus on melanoma, blood, brain and breast cancer. 1. From Discard to Discovery: Rapid KRAS and EGFR Mutation Detection in Lung Cancer Using Cytology Supernatants Institution: MD Anderson Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 20 Researchers evaluated the use of the Idylla™ ctKRAS and ctEGFR Mutation Assays on cytology supernatants from lung cancer patients. The study demonstrated high concordance with next-generation sequencing (NGS) results, reinforcing the Idylla™ assays as valuable tools for rapid testing of cytology supernatants that would otherwise be discarded. 2. Racing for Results: Ultra-Rapid BRAF Mutation Detection Through Fine Needle Aspiration (FNA) of Anaplastic Thyroid Carcinoma (ACT) and High-Grade Follicular Cell-Derived Thyroid Carcinoma (HGFCTC) Institution: Memorial Sloan Kettering Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 31 This study compared the turnaround time and performance of the Idylla™ BRAF Mutation Assay with immunohistochemistry (IHC) and NGS in aggressive thyroid malignancies. The results demonstrated that Idylla™ can provide a significantly faster and reliable assessment of BRAF status in fine needle aspiration samples. 3. Detailed Analysis of MSIsensor2 Signatures in Endometrial Endometrioid Carcinomas with Next Generation Sequencing Institution: University of California, San Francisco. To be presented: Monday 24 March, Stowell-Orbison – Informatics - Poster Board 306 This study utilized MSIsensor2 within an NGS pipeline to assess MSI status across 100 cases of endometrial endometrioid carcinoma (EEC). The research analyzed tumor purity, the impact of mismatch repair (MMR) driver gene mutations, and the correlation of MSI scores with molecular and clinicopathologic data. Orthogonal MSI testing was performed by fragment analysis or Idylla™. 4. Comparison of Two Automated Real-Time PCR Systems for Cytological Smears in NSCLC: IDYLLA™ and AmoyDx® Pan Lung Cancer Panel Institution: Clinica Universidad de Navarra. To be presented: Monday 24 March, Poster II – Cytopathology - Poster Board 44 This study compared the Idylla™ System with the AmoyDx® Pan Lung Cancer Panel for molecular testing on cytological smears in non-small cell lung cancer (NSCLC). Both systems showed high concordance with each other and with NGS results, when available. The Idylla™ System detected additional KRAS mutations not included in the AmoyDx® Panel, underscoring its broader detection capabilities. While NGS remained the gold standard, these automated systems offered faster turnaround times for targeted treatment decisions. 5. Evaluation of Microsatellite Instability Testing by the Rapid Idylla™ MSI Assay in Endometrial and Other Cancers Institution: Icahn School of Medicine at Mount Sinai. To be presented: Tuesday 25 March, Poster IV - General Surgical Pathology This study evaluated the performance of the Idylla™ MSI Assay in endometrial and other cancers, revealing strong sensitivity and specificity in colorectal cancer and highlighting variability in endometrial carcinoma (EC). Adjustments in threshold settings demonstrated improved concordance metrics in EC. 6. Assessment of (Rare) Endometrial Carcinoma with Double Molecular Classifiers Using Limited Panel Next Generation Sequencing (NGS): Evaluation of Surrogate Metrics for Tumor Mutation Burden (TMB) – A Proof of Concept Study Institution: Mayo Clinic. To be presented: Wednesday 26 March, Poster V - Gynecologic and Obstetric Pathology This study assessed a limited NGS panel and its ability to classify rare double-molecular-classifier cases in endometrial carcinoma. It incorporated Idylla™ as an orthogonal CLIA-validated MSI testing method, showcasing its role in resolving discrepancies in molecular classification. 7. Routine Implementation of the Idylla™ Fusion Assay: An Assessment of Performance Based on Prospective Reflex Testing of Non-Small Cell Lung Carcinoma in a Large Laboratory Setting Institution: Memorial Sloan Kettering Cancer Center. To be presented: Wednesday 26 March, Poster V - Pulmonary, Mediastinal, Pleural, and Peritoneal Pathology This study evaluated the routine use of the Idylla™ GeneFusion Assay for detecting fusions in ALK, ROS1, RET, and NTRK1/2/3, as well as MET exon 14 skipping in NSCLC. The Assay demonstrated high sensitivity and specificity, with a fast turnaround time compared to traditional testing methods. In addition, Biocartis will showcase the Idylla™ Platform and its innovations in molecular diagnostics at booth #548, where attendees can learn more about Idylla™'s ability to deliver actionable, molecular biomarker results in only 3 hours. W. Michael Korn, M.D., Chief Medical and Scientific Officer of Biocartis, commented: 'The data presented at USCAP 2025 underscores the versatility and reliability of the Idylla™ Platform across a diverse range of oncology applications. These studies confirm the high concordance between Idylla™ and next-generation sequencing (NGS) in lung cancer, and Idylla™'s ability to detect microsatellite instability (MSI) reliably, demonstrating its clear value in delivering rapid, actionable molecular insights. The integration of Idylla™ into real-world laboratory settings, as highlighted in these independent investigator studies, reinforces its potential to streamline workflows and reduce turnaround times, ultimately improving patient management and outcomes.' ----- END ----- More information: Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium About Biocartis With its revolutionary and proprietary Idylla™ Platform, Biocartis aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, easy, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast, thyroid, brain and blood cancer. More information: Follow us on LinkedIn, Facebook and X (Twitter). Disclaimers The data and conclusions provided in this external publication were derived externally by third parties and have not been validated in the development of the Idylla™ Assays or included in the products' current labelling by Biocartis NV. Biocartis NV products are designed to be used as described in the product-specific instructions. Idylla™ ctKRAS, ctEGFR & BRAF Mutation Assays and Idylla™ GeneFusion & MSI Assays are for Research Use Only (RUO), not for use in diagnostic procedures. Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © March 2025, Biocartis NV. All rights reserved. 1 Lung cancer remains one of the leading causes of cancer-related mortality, strongly linked to smoking and environmental exposures. Advances in biomarker testing have revolutionized treatment by enabling personalized approaches such as targeted therapies and immunotherapy. Depending on the stage of the disease, treatment may involve a combination of surgery, chemotherapy, radiation, or precision medicine. 2 Thyroid Cancer develops in the thyroid gland, often detected as a painless lump in the neck. Prognosis is generally favorable, especially when caught early. Biomarker testing helps assess risk and guide treatment. Standard therapies include surgery, radioactive iodine, and thyroid hormone replacement. 3 Endometrial Cancer is a malignancy of the uterine lining, that most commonly affects postmenopausal women. Biomarker testing plays a crucial role in assessing prognosis and guiding treatment decisions. Management typically involves surgery, with additional therapies such as radiation or hormone treatment considered based on individual risk factors and molecular profiling. 4 Colorectal Cancer is affecting the colon or rectum, often linked to lifestyle and genetic factors. Biomarker testing helps guide treatment decisions, particularly in targeted therapy and immunotherapy. Testing for these markers can identify patients who may benefit from specific therapies, such as anti-EGFR or immune checkpoint inhibitors.
Yahoo
18-03-2025
- Business
- Yahoo
Press Release Biocartis NV: Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting
PRESS RELEASE 18/03/2025, 07:00 CET Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla™ in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting Mechelen, Belgium, 18 March 2025 – Biocartis NV ('Biocartis'), an innovative molecular diagnostics company, is pleased to announce research on the Idylla™ Platform from several renowned institutions at the upcoming United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting, taking place from 22-27 March in Boston, MA, US. Seven abstracts from leading research and academic institutions will be presented as posters, highlighting the rapid, fully automated molecular testing capabilities of the Idylla™ Platform across several different cancer types, including lung cancer1, thyroid cancer2, endometrial carcinoma3 and colorectal cancer4. Biocartis also continues to focus on melanoma, blood, brain and breast cancer. 1. From Discard to Discovery: Rapid KRAS and EGFR Mutation Detection in Lung Cancer Using Cytology Supernatants Institution: MD Anderson Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 20 Researchers evaluated the use of the Idylla™ ctKRAS and ctEGFR Mutation Assays on cytology supernatants from lung cancer patients. The study demonstrated high concordance with next-generation sequencing (NGS) results, reinforcing the Idylla™ assays as valuable tools for rapid testing of cytology supernatants that would otherwise be discarded. 2. Racing for Results: Ultra-Rapid BRAF Mutation Detection Through Fine Needle Aspiration (FNA) of Anaplastic Thyroid Carcinoma (ACT) and High-Grade Follicular Cell-Derived Thyroid Carcinoma (HGFCTC) Institution: Memorial Sloan Kettering Cancer Center. To be presented: Monday 24 March, Stowell-Orbison – Cytopathology - Poster Board 31 This study compared the turnaround time and performance of the Idylla™ BRAF Mutation Assay with immunohistochemistry (IHC) and NGS in aggressive thyroid malignancies. The results demonstrated that Idylla™ can provide a significantly faster and reliable assessment of BRAF status in fine needle aspiration samples. 3. Detailed Analysis of MSIsensor2 Signatures in Endometrial Endometrioid Carcinomas with Next Generation Sequencing Institution: University of California, San be presented: Monday 24 March, Stowell-Orbison – Informatics - Poster Board 306 This study utilized MSIsensor2 within an NGS pipeline to assess MSI status across 100 cases of endometrial endometrioid carcinoma (EEC). The research analyzed tumor purity, the impact of mismatch repair (MMR) driver gene mutations, and the correlation of MSI scores with molecular and clinicopathologic data. Orthogonal MSI testing was performed by fragment analysis or Idylla™. 4. Comparison of Two Automated Real-Time PCR Systems for Cytological Smears in NSCLC: IDYLLA™ and AmoyDx® Pan Lung Cancer Panel Institution: Clinica Universidad de be presented: Monday 24 March, Poster II – Cytopathology - Poster Board 44 This study compared the Idylla™ System with the AmoyDx® Pan Lung Cancer Panel for molecular testing on cytological smears in non-small cell lung cancer (NSCLC). Both systems showed high concordance with each other and with NGS results, when available. The Idylla™ System detected additional KRAS mutations not included in the AmoyDx® Panel, underscoring its broader detection capabilities. While NGS remained the gold standard, these automated systems offered faster turnaround times for targeted treatment decisions. 5. Evaluation of Microsatellite Instability Testing by the Rapid Idylla™ MSI Assay in Endometrial and Other CancersInstitution: Icahn School of Medicine at Mount be presented: Tuesday 25 March, Poster IV - General Surgical Pathology This study evaluated the performance of the Idylla™ MSI Assay in endometrial and other cancers, revealing strong sensitivity and specificity in colorectal cancer and highlighting variability in endometrial carcinoma (EC). Adjustments in threshold settings demonstrated improved concordance metrics in EC. 6. Assessment of (Rare) Endometrial Carcinoma with Double Molecular Classifiers Using Limited Panel Next Generation Sequencing (NGS): Evaluation of Surrogate Metrics for Tumor Mutation Burden (TMB) – A Proof of Concept StudyInstitution: Mayo be presented: Wednesday 26 March, Poster V - Gynecologic and Obstetric Pathology This study assessed a limited NGS panel and its ability to classify rare double-molecular-classifier cases in endometrial carcinoma. It incorporated Idylla™ as an orthogonal CLIA-validated MSI testing method, showcasing its role in resolving discrepancies in molecular classification. 7. Routine Implementation of the Idylla™ Fusion Assay: An Assessment of Performance Based on Prospective Reflex Testing of Non-Small Cell Lung Carcinoma in a Large Laboratory Setting Institution: Memorial Sloan Kettering Cancer be presented: Wednesday 26 March, Poster V - Pulmonary, Mediastinal, Pleural, and Peritoneal Pathology This study evaluated the routine use of the Idylla™ GeneFusion Assay for detecting fusions in ALK, ROS1, RET, and NTRK1/2/3, as well as MET exon 14 skipping in NSCLC. The Assay demonstrated high sensitivity and specificity, with a fast turnaround time compared to traditional testing methods. In addition, Biocartis will showcase the Idylla™ Platform and its innovations in molecular diagnostics at booth #548, where attendees can learn more about Idylla™'s ability to deliver actionable, molecular biomarker results in only 3 hours. W. Michael Korn, M.D., Chief Medical and Scientific Officer of Biocartis, commented: 'The data presented at USCAP 2025 underscores the versatility and reliability of the Idylla™ Platform across a diverse range of oncology applications. These studies confirm the high concordance between Idylla™ and next-generation sequencing (NGS) in lung cancer, and Idylla™'s ability to detect microsatellite instability (MSI) reliably, demonstrating its clear value in delivering rapid, actionable molecular insights. The integration of Idylla™ into real-world laboratory settings, as highlighted in these independent investigator studies, reinforces its potential to streamline workflows and reduce turnaround times, ultimately improving patient management and outcomes.' ----- END ----- More information: info@ Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium About Biocartis With its revolutionary and proprietary Idylla™ Platform, Biocartis aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, easy, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast, thyroid, brain and blood cancer. More information: Follow us on LinkedIn, Facebook and X (Twitter). Disclaimers The data and conclusions provided in this external publication were derived externally by third parties and have not been validated in the development of the Idylla™ Assays or included in the products' current labelling by Biocartis NV. Biocartis NV products are designed to be used as described in the product-specific instructions. Idylla™ ctKRAS, ctEGFR & BRAF Mutation Assays and Idylla™ GeneFusion & MSI Assays are for Research Use Only (RUO), not for use in diagnostic procedures. Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © March 2025, Biocartis NV. All rights reserved. 1 Lung cancer remains one of the leading causes of cancer-related mortality, strongly linked to smoking and environmental exposures. Advances in biomarker testing have revolutionized treatment by enabling personalized approaches such as targeted therapies and immunotherapy. Depending on the stage of the disease, treatment may involve a combination of surgery, chemotherapy, radiation, or precision medicine.2 Thyroid Cancer develops in the thyroid gland, often detected as a painless lump in the neck. Prognosis is generally favorable, especially when caught early. Biomarker testing helps assess risk and guide treatment. Standard therapies include surgery, radioactive iodine, and thyroid hormone replacement. 3 Endometrial Cancer is a malignancy of the uterine lining, that most commonly affects postmenopausal women. Biomarker testing plays a crucial role in assessing prognosis and guiding treatment decisions. Management typically involves surgery, with additional therapies such as radiation or hormone treatment considered based on individual risk factors and molecular profiling.4 Colorectal Cancer is affecting the colon or rectum, often linked to lifestyle and genetic factors. Biomarker testing helps guide treatment decisions, particularly in targeted therapy and immunotherapy. Testing for these markers can identify patients who may benefit from specific therapies, such as anti-EGFR or immune checkpoint in to access your portfolio
