Core Insights - Insight Molecular Diagnostics Inc. (iMDx) is preparing for its FDA submission of the GraftAssureDx™ test kit, with 95% of the submission work completed, including product design and technical transfer to manufacturing [3][4][7] - The company aims to enhance organ health testing for kidney transplant patients, targeting a market exceeding $1 billion for transplant rejection testing [2][7] - iMDx is also advancing its regulatory submissions in Europe, expecting to submit for CE mark and EU IVDR in the first half of 2026 after successful audits [4][7] Regulatory Submission Progress - The FDA submission for GraftAssureDx™ is nearly complete, with remaining tasks focused on quality control for newly developed software [3][4] - iMDx has made significant progress in regulatory compliance, positioning itself for market access in Europe following successful audits by TÜV SÜD [4][7] Market Engagement and Expansion - iMDx has engaged 20 global transplant centers, including its first Canadian site, to utilize GraftAssure™ technology [6][7] - The company is driving clinical community engagement through pilot programs and a novel registry, with 17 U.S. transplant centers planning to send samples in 2026 [5][10][7] Clinical Innovation and Research - The GraftAssureCore registry study aims to establish the clinical utility of dd-cfDNA testing, with a target of engaging 50 U.S. transplant centers [9] - iMDx's technology quantifies donor-derived cell-free DNA (dd-cfDNA), which is recognized as a reliable biomarker for transplant rejection [11]

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].