Specimen Strategy: Avoid Months of Delay

Strong piece from Jim Boushell, DCN Dx's Senior VP, on why specimen strategy should be part of your early planning process and not a “we’ll source it later” project. This article is a useful reminder of what to define early so your specimen set and data package match the intended use. Clear, practical, and informed by his decades in diagnostics and biorepository work. #IVD #Diagnostics #Biospecimens #ClinicalResearch #CRO 

Calaris Diagnostics was founded on a simple but demanding belief. To truly democratize diagnostics, we must use easy-collect biofluids to generate powerful diagnostic signals. Across many disease areas, patients fall through cracks not because tools are non-existent, but because diagnostics are: 1/ Too invasive 2/ Late in the disease course 3/ Difficult to access due to necessary infrastructure We believe rigorously-built, non-invasive, and accessible testing changes this paradigm. At Calaris, we focus on developing easy-collect biofluid Dx technologies that prioritize: 1/ Biological relevance 2/ Thoughtful assay design 3/ Responsible translation from benchtop research to real-world use Our work sits at the intersection of molecular biology, clinical insight, and disciplined product development. This means moving deliberately, validating assumptions early, and being precise about where any diagnostic sits in the care pathway. We are building with a long-term view that is grounded in science and aligned with ground-level realities that clinicians face daily. Join us on this journey of building. Calaris Diagnostics Clarity without compromise

Bruce Quinn has done it again — a must-read article that explores how pathology and molecular testing are shaped today, including historical OIG, Stark, and MAC considerations that can unintentionally create barriers for sites trying to implement modern precision medicine workflows (e.g pathologist-initiated molecular/biomarker testing). If you’re involved in integrating pathologist-initiated biomarker testing or working on advocacy to help more sites adopt precision medicine, this piece is essential reading. 🔗 https://lnkd.in/gQ_FhEah

Better diagnostics lead to better care, and clarity is essential at every step of the patient journey. Synatra™ simplifies complex hematology by combining morphology, flow cytometry, FISH, cytogenetics, molecular testing, and NGS into one concise, full-color report. This integrated approach delivers timely, clear, and actionable insights, empowering clinicians to make informed decisions with confidence. When information is easier to understand and faster to access, care becomes more precise, efficient, and truly patient-focused. Find out more: https://emeritusdx.com #diagnostics #precisionmedicine #patientcare #healthcareinnovation #emeritusdx

Better diagnostics lead to better care, and clarity is essential at every step of the patient journey. Synatra™ simplifies complex hematology by combining morphology, flow cytometry, FISH, cytogenetics, molecular testing, and NGS into one concise, full-color report. This integrated approach delivers timely, clear, and actionable insights, empowering clinicians to make informed decisions with confidence. When information is easier to understand and faster to access, care becomes more precise, efficient, and truly patient-focused. Find out more: https://emeritusdx.com #diagnostics #precisionmedicine #patientcare #healthcareinnovation #emeritusdx

🚀 ANDis 7100 — Sample In. Results Out. 3DMed’s next-generation, cost-effective molecular automation system integrates nucleic-acid extraction, PCR setup, PCR detection, and data analysis in one compact platform—designed for CLIA-moderate/high-complexity labs and LDT workflows. ✔ Reduced hands-on time and workflow variability ✔ Consistent Ct performance across respiratory, STI, and oncology assays ✔ Flexible sample types and assay-agnostic design ✔ Smaller footprint and lower total cost of ownership vs. big-box systems 👀 Stay tuned — Early Access Program is coming soon. 话题标签 #MolecularDiagnostics #ClinicalLab #LabAutomation #PCR #qPCR #NucleicAcidExtraction #LDT #CLIALab #LabOperations #DiagnosticsInnovation #CostEffective #3DMed

✨ New article from DISGENET is now available on bioRxiv! I’m thrilled to announce that our latest DISGENET research is now live on bioRxiv. This work reflects our continued commitment to building the most comprehensive and AI-ready biomedical knowledge platform for drug discovery and precision medicine. Whether you're working on target prioritization, biomarker validation, or drug repositioning, we believe this research will be valuable for your work. Dive in, and don't hesitate to share your feedback. Understanding how the community uses DISGENET helps us shape what comes next. 🔗 Link to the article https://lnkd.in/eCqayW9T #DISGENET #PrecisionMedicine #DrugDiscovery #DataForTomorrowsHealth #LifeSciencesAI 

𝗕𝗹𝗼𝗼𝗱𝗣𝗔𝗖 𝗵𝗮𝘀 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 𝗮𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝘃𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗳𝗼𝗿 𝘁𝘂𝗺𝗼𝗿-𝗶𝗻𝗳𝗼𝗿𝗺𝗲𝗱 𝗰𝘁𝗗𝗡𝗔 𝗠𝗥𝗗 𝗮𝘀𝘀𝗮𝘆𝘀 (𝗝𝗖𝗢 𝗣𝗿𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆). Up until now, MRD tests have been validated in many different ways, making it hard for regulators, payers, and clinicians to compare performance or build confidence across platforms. The new technology-agnostic protocols cover limit of detection, precision, robustness, and sample stability, specifically for tumor-informed MRD, not for early detection or therapy selection. This is a significant step in establishing MRD as a recognized clinical category. With analytical validation becoming more standardised, differentiation will increasingly come from clinical utility, outcomes data, and how the tests fit into real-world workflows. #PrecisionOncology #LiquidBiopsy #MRD #ctDNA #CancerDiagnostics #ClinicalInnovation #JPM2026 #PersonalizedMedicine

Companion Diagnostics (CDx) are central to precision medicine – aligning therapies with patient profiles through biomarker-driven decisions. At IQVIA Laboratories, we support genomic CDx studies with our global footprint, harmonized processes, and experienced scientific leadership. Explore how we partner across sponsors and IVDs to accelerate high-quality CDx studies. Get the Insights: https://lnkd.in/eaSQKwk4

If next-gen ADCs against target X really win the race, it likely won’t be because someone found a “magic payload.” Payloads are becoming commoditized. Differentiation is shifting to where the therapeutic window actually lives: calibrated bystander effect and linker stability. Those are the levers that determine dose intensity, fewer dose reductions, and whether combinations are feasible, rather than hitting a wall of class toxicity. But there’s an uncomfortable truth: even a great ADC becomes a “mid signal” if we don’t control the population. Expression heterogeneity is a primary mechanism of effect dilution: you enroll patients “on paper,” while the biology has already shifted (different lesion, different clone, different timepoint). The outcome is predictable - screen failures, site-to-site variability, and weaker efficacy signals where you expected clarity. That’s why next-gen ADCs aren’t just chemistry. They’re a “platform + patient navigation” package: a tissue-anchored baseline (IHC/tissue, standardized pre-analytics) plus a second track for dynamics (ctDNA/RNA/additional markers) to capture temporal change and keep the signal from dissolving into noise. The question I’d ask any ADC program is simple: are we trying to win on payload -or are we building a controllable platform and a testing strategy that prevents signal dilution? #oncology #ADC #biomarkers #clinicaldevelopment #precisionmedicine