Endometrial Endometrioid Adenocarcinoma

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 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 CancersInstitution: 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 StudyInstitution: 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: www.biocartis.com info@biocartis.com 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: www.biocartis.com. 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.

In collaboration with leading cancer centers, research results to be presented from seven studies across a wide range of tumor types demonstrating Caris' impact on precision medicine IRVING, Texas, Sept. 4, 2024 /PRNewswire/ -- Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, today announced that the company and collaborators from the biopharma industry and leading cancer centers, including those within the Caris Precision Oncology Alliance™ (POA), will collectively present seven studies across a wide range of tumor types at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain from September 13-17, 2024 (Booth #608). The findings demonstrate the power of Caris' comprehensive multi-modal database to enable novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan and response to treatment. Continue Reading "The research being presented at this year's ESMO Congress is a testament to Caris' continued commitment to data-driven molecular innovation and the power of our ever-expanding network of collaborators to answer some of today's pressing questions in precision oncology," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The findings underscore the critical role of comprehensive profiling in cancer care and the power of large clinico-genomic datasets to enable the identification of new biomarkers with clinical implications across diverse tumor types. Through extensive sequencing and data analysis efforts, we are unlocking new avenues for tailored therapies to revolutionize cancer treatment." The findings demonstrate the power of Caris' comprehensive multi-modal database to enable novel insights into cancer Post this "Our comprehensive molecular profiling coupled with rich clinical data is enabling Caris to help clinicians make the best treatment choices, researchers to discover novel cancer biology, and the biopharmaceutical industry to develop the next breakthrough medicines," said Caris President David Spetzler, MS, PhD, MBA. "Our vast real-world evidence from over 689,000 cases, including over 550,000 with matched molecular data and outcomes, enables our team and research collaborators to better understand the biological hallmarks of cancers and how they impact clinical outcomes, paving the way for personalized therapies and improved patient outcomes." Mini oral presentations include : Metastatic hormone receptor-positive breast cancer outcomes in 628 patients with BRCA1, BRCA2, or PALB2 pathogenic variants: Real world data analysis of genomics and targeted therapy sequencing. (Abstract Number: 342MO) September 15, 2024 Atlas of tertiary lymphoid structures in solid tumors: Genomic features and prediction of response to immunotherapy. (Abstract Number: 75MO) September 16, 2024 Poster presentations include: Impact of TLS Status on outcomes in patients with high TMB or MSI-high status treated with immune checkpoint inhibitors. (Abstract Number: 1051P) September 14, 2024 Comparison of breast and gastric HER2 immunohistochemistry (IHC) scoring criteria in the assessment of endometrial endometrioid adenocarcinoma (EEA). (Abstract Number: 739P) September 14, 2024 METPRO: Evaluating prognostic value of c-Met protein overexpression and concurrent biomarker presence. (Abstract Number: 1303P) September 14, 2024 Genomic landscape & prognostic impact of HER2 low-expressing tumors. (Abstract Number: 126P) September 15, 2024 Molecular and immunologic correlates of high PSMA/FOLH1 mRNA expression in prostate cancer (PC). (Abstract Number: 1653P) September 15, 2024 Poster and abstract summaries highlighting the Caris research presented at ESMO 2024 will be available onsite at Caris' Booth #608. The full abstracts will be available on the Caris website at the event's conclusion. The Caris POA includes 95 cancer centers, academic institutions, research consortia and healthcare systems, including 46 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients. About Caris Life Sciences Caris Life Sciences® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multi-modal database and computing capability needed to analyze and unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides an unmatched platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine in order to improve the human condition, and we value our employees as much as we do our patients of every creed, color, sex, sexual orientation and religion. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S., Europe, Asia and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media: Corporate Communications [email protected] 214.294.5606 SOURCE Caris Life Sciences

Following the news, Aadi’s stock also took a significant hit and was down by over 30% in premarket trading today, compared to the market close on 19 August. Image Credit: Wafi Zimamul / Shutterstock. Aadi Biosciences has instituted cash-saving measures after the company decided to halt the registrational Phase II PRECISION1 trial for its mTOR inhibitor, nab-sirolimus. The company’s decision to discontinue the trial was made after an analysis done by the Independent Data Monitoring Committee (IDMC) found the “study was unlikely to exceed an efficacy threshold necessary to support an accelerated approval”. Concurrently, Aadi also decided to pause enrolment in two other Phase II trials of nab-sirolimus for advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumours (NETs), respectively. As part of the cash savings initiative, Aadi is also reducing its research & development headcount by 80%. The pipeline and workforce restructure are expected to extend Aadi’s cash runway into H2 2026. The company reported cash reserves of $78.6m as of 30 June 2024. The news broke after markets closed on 20 August, causing Aadi’s stock to also take a significant hit. The company’s stock was down by more than 30% in premarket trading today. See Also: Innovent’s Dupert approved in China to treat lung cancer Pathalys secures $105m to advance SHPT drug through approval This is not the first time that the PRECISION1 trial (NCT05103358) data significantly impacted Aadi’s stock price. In December, the company stock fell by almost 57% after it released interim data from the PRECISION1 study . In the analysis done with the first 40 participants, at a minimum of 4.5 months of follow-up, 22 and ten participants in the TCS1 and TCS2 arms achieved an overall response rate of 26% and 11%, respectively. Despite the data being largely positive, it did not sway the company’s investors. “While nab-sirolimus showed monotherapy activity in the study population, the trial fell short of delivering what we believe would be required to support an accelerated approval in the broad TSC1/TSC2 inactivating mutations indication. We look forward to providing the full trial analysis at a later date,” said David Lennon, president and CEO of Aadi Bioscience. “Given the change in the development pipeline, we have taken the necessary steps to immediately preserve cash runway, and have hired an advisory firm to explore all options to maximize value for shareholders.” The open-label Phase II trial (NCT05997056) of nab-sirolimus in NETs has enrolled 10 out of the 21 expected participants. The Phase II study (NCT05997017) of the therapy in advanced or recurrent EEC has enrolled 20 out of 29 expected participants. Aadi noted that the current levels of recruitment in the two trials are expected to be “sufficient” to assess initial efficacy signals, which is expected by the end of the year. Nab-sirolimus is a sirolimus protein-bound particle that targets the mechanistic target of rapamycin (mTOR), which plays a pivotal role in cell growth and proliferation. Aadi’s nab-sirolimus is marketed as Fyarro and was approved by the US Food and Drug Administration (FDA) for adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumour (PEComa), in 2021. Following the pipeline restructure, Aadi plans to shift its focus to commercial activities Fyarro in PEComa. The therapy generated $24.4m in sales last year, as per the company’s financials. While Fyrro sales dipped by 8.8% in Q1, these were back on track and grew to $6.2m in Q2 this year.