Core Insights - Biodesix, Inc. will present its Corporate and Scientific updates at the 2025 AMP Annual Meeting in Boston from November 12-15, highlighting its diagnostic solutions and strategic partnerships [1][2]. Group 1: Corporate Workshop - A workshop led by Dr. Gary Pestano will focus on Biodesix's R&D Roadmap, showcasing both near- and long-term diagnostic services [2]. - Key partners such as Memorial Sloan Kettering Cancer Center, Bio-Rad Laboratories, and Thermo Fisher Scientific will provide updates during the workshop [2]. Group 2: Molecular Testing Approaches - The workshop will emphasize new approaches to comprehensive molecular testing, aiming for accurate results with rapid turnaround, high throughput, and low sample requirements [3][4]. - Advances in molecular diagnostic technologies, including NGS, ddPCR, and Mass Spectrometry, will be discussed, along with their clinical utility and research concepts for monitoring therapeutic responses [4]. Group 3: Company Overview - Biodesix is dedicated to enhancing clinical care and outcomes for patients, particularly in lung disease, through its diagnostic tests like Nodify Lung® and IQLung® [7]. - The company provides Development Services to biopharmaceutical and life sciences institutions, supporting the development of diagnostic tests and therapeutics [7]. Group 4: Presentation and Engagement - A poster presentation on the impact of blood collection tubes on a novel device for enriching circulating tumor cells will be presented by Leisa Jackson on November 15 [6]. - Biodesix executives and experts will be available at booth 647 to discuss the company's offerings during the AMP Annual Meeting [5].

Core Insights - Biodesix has signed an expanded partnership agreement with Bio-Rad to develop and clinically validate the ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer testing [1][2][4] - The assay will enable highly sensitive detection and quantification of multiple ESR1 mutations from ctDNA samples, which is critical for HR+/HER2- advanced breast cancer treatment [2][3] - Biodesix plans to offer the validated assay as a test service at its accredited CLIA-CAP laboratory and will seek reimbursement through the Centers for Medicare & Medicaid Services (CMS) [3] Company Developments - The first assay to be validated under the agreement is Bio-Rad's ddPLEX ESR1 Mutation Detection Assay, which is essential for the new generation of therapies known as oral selective estrogen receptor degraders (SERDs) [2] - Biodesix aims to improve clinical care and outcomes for patients through its diagnostic solutions, including the Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance [5] Market Impact - The emergence of ESR1 mutations as biomarkers for breast cancer has significantly increased global demand for rapid and sensitive assays in the oncology market [4] - The collaboration between Biodesix and Bio-Rad is expected to enhance access to sensitive biomarker detection for advanced breast cancer, addressing clinical needs with speed and precision [4] Upcoming Events - Both companies will present more details on their R&D visions, partnerships, and commercial roadmaps at the upcoming AMP conference scheduled for November 11-15 in Boston, MA [4]

Core Insights - Insight Molecular Diagnostics Inc. (iMDx) is actively participating in two significant industry conferences to showcase its GraftAssure™ technology and its clinical kitted test under development [1][4] - The company aims to highlight the clinical applications of transplant rejection testing, particularly in longitudinal surveillance and therapeutic response monitoring [2][3] Conference Participation - iMDx is hosting a symposium at the IATDMCT annual meeting in Singapore from September 21 to 24, 2025, focusing on the benefits of in-house testing for transplant rejection [2][6] - The company will also present at the ASHI annual meeting in Orlando, Florida, from October 6 to 10, 2025, discussing GraftAssureIQ, a research-use-only test kit [4][8] Technology and Product Development - GraftAssure technology is designed to detect transplant rejection and monitor treatment response, significantly reducing time-to-rejection diagnosis in high-risk kidney transplant patients [3][5] - The GraftAssureDx, currently in development, is expected to be submitted for FDA review by the end of 2025, targeting an estimated $1 billion addressable market for kitted transplant rejection testing [5][15] Strategic Partnerships - iMDx is collaborating with Bio-Rad Laboratories to present on GraftAssureIQ, emphasizing the potential of in-house testing for convenience and efficiency in transplant care [4][5] Market Position - The company is focused on democratizing access to molecular diagnostic testing, particularly for kidney transplant patients, utilizing donor-derived cell-free DNA (dd-cfDNA) as a biomarker for transplant rejection [16][13]