Odelle Technology

Revolutionising Cancer Diagnostics: Can Digistain® Secure the Reimbursement It Deserves? In the battle against #cancer, timely and precise diagnosis is everything. At the forefront of this revolution, Digistain a breakthrough in infrared spectroscopy offers #pathologists a new lens to decode #tumour biochemistry with unprecedented clarity and speed. Imagine assessing a tumour’s molecular “wiring” directly in a lab, slashing wait times and costs by a staggering 75% compared to traditional molecular tests. That’s what Digistain is enabling, by giving oncologists a powerful, low-cost tool to help prevent unnecessary chemotherapy while sparing patients the brutal side effects of overtreatment. Yet the journey towards reimbursement isn’t straightforward. For all its promise, Digistain faces an uphill challenge in entering healthcare systems traditionally bound to existing molecular diagnostics like Oncotype DX. These incumbents are deeply rooted in clinical practice and backed by extensive data, creating high hurdles for new technologies like Digistain to gain reimbursement approval. So, what’s different with Digistain? The science of infrared spectroscopy is pivotal. Unlike conventional tests, Digistain uses infrared light to reveal molecular markers that tell us about a tumour’s aggressiveness and potential for recurrence. By measuring aneuploidy—an imbalance in chromosome numbers in tumour cells—Digistain quantifies the DNA-to-protein ratio, offering a new prognostic score that rivals established methods in accuracy while cutting down costs significantly. This shift from subjective visual grading to objective molecular analysis could mean a profound shift in how we identify high-risk patients who truly need aggressive treatment. But to secure reimbursement, Digistain must prove its worth through rigorous real-world evidence, economic analyses, and alignment with value-based care models. As it scales to countries across the globe, including low- and middle-income settings where affordability is critical, Digistain’s path forward will depend on showcasing reliable outcomes in diverse patient populations. The potential of Digistain is enormous, but the healthcare land scape must accommodate this new wave of diagnostics to ensure patients everywhere receive the most personalised, effective cancer care possible. #CancerDiagnostics #Oncology #Digistain #InfraredSpectroscopy #HealthcareInnovation #MolecularDiagnostics #ReimbursementChallenge #RealWorldEvidence #PrecisionMedicine #ivd Cancer Research UK Science and Innovation Nick Wright Barts Cancer Institute (Queen Mary University of London) https://lnkd.in/e9M4gymn

Breast Cancer Awareness Month: Advancing Precision with New Diagnostic Tools Cerca Biotech   As we mark Breast Cancer Awareness Month, it’s vital to highlight the progress being made in the tools we use to diagnose and treat this complex disease. Among the latest innovations is the MammaTyper® assay, a technology that’s changing the way we understand and treat breast cancer by providing more precise insights into tumour biology.   Breast cancer is not one-size-fits-all. It’s a diverse disease, and the treatment approach often hinges on the accurate detection of biomarkers like HER2, oestrogen receptor (ER), progesterone receptor (PR), and Ki67—key indicators that help guide treatment decisions. Traditionally, these markers have been assessed using immunohistochemistry (IHC), a well-established technique but one that has limitations.   Variability in results can occur due to subjective interpretation, particularly for markers like Ki67, which can have a significant impact on treatment plans. This is where the MammaTyper® assay steps in. Using reverse transcription quantitative PCR (RT-qPCR), MammaTyper® measures the mRNA levels of these biomarkers directly from tumour tissue, offering a more precise, objective, and reproducible method. This is especially crucial for patients with HER2-low or borderline cases, where traditional IHC can be inconclusive. By providing clear and quantitative data on the expression of these markers, MammaTyper® enables doctors to make more informed decisions about the need for therapies like anti-HER2 treatment.   In recent studies, including international trials, the MammaTyper® assay has shown high concordance with IHC but with significantly reduced variability, especially in identifying HER2 status. This technology improves the ability to predict which patients will benefit from specific therapies, reducing the risk of recurrence for those with HER2-positive breast cancer by ensuring the right treatment is given from the start   Moreover, #MammaTyper® offers clearer insights into Ki67 expression, a marker used to assess how rapidly cancer cells are dividing. Traditional IHC assessments of Ki67 can be inconsistent, but with MammaTyper®, doctors get a more reliable picture of tumour proliferation, aiding in decisions about the intensity of treatment needed.   During this Breast Cancer Awareness Month, let’s celebrate the progress being made and acknowledge the importance of integrating these advanced diagnostic tools into everyday clinical practice. Early, accurate diagnosis and personalised treatment can transform lives—and that’s a future we can all be hopeful for. Jay Z. Zhang, MS, JD Rich Hughes Vinicio Tassani Lucy Lehane Sysmex Corporation Sysmex Netherlands & Belgium Sysmex France Sysmex Deutschland BÜHLMANN Laboratories AG Emad Rakha Ralph Wirtz Sunil Badve Cancer Research UK (CRUK) #CANCER #INNOVATION Breast Cancer Alliance Breast Cancer Now Cancer Research UK Science and Innovation

🚨 Major Update in France for Companion Diagnostics (CDx)! 🚨 On October 9, 2024, France released a new version of the Nomenclature of Medical Biology Procedures (NABM 93), representing a significant leap forward for precision oncology and personalized medicine. 🧬🔬 Five new diagnostic codes were introduced, with particular focus on companion diagnostics. Key highlights include: 🔹 Code 4510: Detecting EGFR mutations in non-small cell lung cancer (NSCLC)—essential for guiding targeted therapies like AstraZeneca's Tagrisso and Roche’s Tarceva. This test ensures that NSCLC patients receive the right therapy based on their genetic profile, potentially improving outcomes. 🔹 Code 4511: Detection of KRAS and NRAS mutations in colorectal cancers—crucial for identifying patients who will benefit from anti-EGFR therapies like Amgen’s Vectibix and Merck Group’s Erbitux. This code reinforces the importance of personalized care, avoiding ineffective treatments for patients with mutations that render these therapies less effective. These updates emphasize the growing impact of companion diagnostics in the treatment of cancer, allowing doctors to tailor therapies more precisely to the genetic makeup of tumors. This aligns with the broader vision of Roche Diagnostics, Foundation Medicine, and Qiagen, all of which are pushing the boundaries of personalized healthcare by offering cutting-edge genomic tests. From a reimbursement perspective, these new codes integrate seamlessly into the French healthcare system, ensuring more patients have access to life-changing diagnostic tools. 🇫🇷 The updates also reflect France’s commitment to fostering innovation in healthcare, with clear reimbursement pathways making advanced genomic testing more accessible. For labs and clinicians, these changes will streamline the offering of these advanced tests, improving access and speeding up diagnosis and treatment decisions. 🚀 Exciting times for stakeholders involved in oncology, genomic testing, and precision medicine! Let’s continue pushing the boundaries of personalized healthcare. #CompanionDiagnostics #PrecisionOncology #EGFR #KRAS #NRAS #NABM93 #PersonalizedMedicine #RocheDiagnostics #Amgen #Merck #AstraZeneca #FoundationMedicine #Qiagen #HealthcareInnovation #Reimbursement https://lnkd.in/ebcde_Ck

🌟 Exploring @MedEnvoy’s Regulatory Expertise 🌟 While we haven't had the opportunity to collaborate with MedEnvoy Global their ongoing work and dedication to the healthcare industry have certainly caught our attention. MedEnvoy has been at the forefront of helping small to medium-sized enterprises (SMEs) navigate the complex regulatory landscape, particularly with transitions to MDR and IVDR compliance. In 2024 alone, MedEnvoy has: Actively supported clients through RAPS Convergence 2024, sharing insights on AI and Machine Learning for regulatory processes and best practices for MDR/IVDR compliance. Assisted with Swissmedic’s deadlines for legacy devices, ensuring smooth transitions for manufacturers under updated #EU-#MDR regulations. Continued expanding their services globally, acting as a regulatory importer and in-country representative in key markets like the EU, UK, Switzerland, Australia, and the US. Focused on ensuring compliance for medical devices, such as Australia's 3G shutdown impacting older health devices. #RegulatoryCompliance #MDR #IVDR #HealthcareInnovation #MedTech Dr. Stefan TuschenRene van de ZandeDaryl WisdahlDaniëlle SleegersVicki PartridgeRocio Fallas, M.EngStaci DennisEmma KnijnClaire McMorrowGiulia GuerreschiPepijn BoumansBirgit Holl Nia ChavdarovaIrene van Schie de la FuenteKarch KooijmanRachael RodriguezAbhay TaukMelle HavermansAlexandra SimaBroadleyPenelope NunnRenée ConleyBarbara MedenicaSergey PanchinLoubna BoutalbiGarnett-SpearAlyssa BarthelemyDarlene AltmanLindsay BartholomewAlly GonzalezBenjamin Warner Ada ÖztürkNoah BaconReinoud MoensNiek GerzonMykyta (Nick) RomanishynManuella de Cantuária BórioRaphael Meghan Simoens Ashaley,https://lnkd.in/ec335stH

Our newest podcast is with Giovanni Lauricella and @John Sousa M.D. at Lifeblood Capital + Talent who talk to Steven Haken about the company, some great success stories and the challenges faced by MedTech startups. Giovanni Lauricella is the Managing Partner of Lifeblood Capital + Talent, an executive and professional-level recruitment firm, and brings 15 years of experience designing and building teams exclusively for the global MedTech industry. Additionally, Giovanni is a board member for both publicly traded and privately held medical device companies as well as being an active angel investor and limited partner for venture capital funds.  John Sousa serves as a Senior Recruiter and Medical Officer at Lifeblood Capital + Talent. John's professional experience includes being a physician and completing three years of General Surgery residency training at Stanford and Florida Atlantic University. He is passionate about scaling impact to patients around the world through supporting entrepreneurship in the MedTech space, harnessing his depth and breadth of clinical experience in General Surgery, as well as his business acumen and interpersonal skills.  John joined Lifeblood Capital in July 2023, where he has advised and built teams for the most cutting-edge MedTech companies globally.  Watch the podcast to find out more. Conformal Medical Neurent Medical Biorithm SymPhysis Medical Frank Jaskulke Steve Motes Outset Medical, Inc. The University of Texas Health Science Center at Houston (UTHealth Houston) Zoltan Kevei Adam Sachs Mike Dineen Vic Trevino Aaron Chalekian Boston Scientific Adam Groothuis David Breant Dieter Krines Brian Shields Venus Medtech Europe   #medtech #healthcare #podcast #health #surgeon #recruitment #talent

🔬 Lumos Diagnostics Advancing Diagnostic Precision in Respiratory Infections 🔬 In clinical settings, differentiating between viral and bacterial respiratory infections remains a significant challenge due to overlapping symptoms. FebriDx® offers a scientifically validated solution to this diagnostic dilemma. FebriDx is a 10-minute, point-of-care test that uses a simple fingerstick blood sample to measure two biomarkers: C-reactive Protein (#CRP) for general inflammation, often elevated in bacterial infections. Myxovirus Resistance Protein A (#MxA), is a specific marker of viral infections. By combining CRP and MxA, FebriDx accurately distinguishes between viral and bacterial infections, helping clinicians make informed decisions on antibiotic prescribing. This is particularly important in the context of antimicrobial resistance (AMR), where inappropriate antibiotic use must be minimized. Clinical Studies: A recent NIHR feasibility study in primary care demonstrated a 40% reduction in antibiotic prescriptions for lower respiratory tract infections (LRTI) when FebriDx was used as a diagnostic aid. In pediatric populations, a study in Spain showed FebriDx reduced inappropriate antibiotic use by 40% and helped avoid unnecessary diagnostic procedures such as chest X-rays. FebriDx has also been validated in emergency departments, with data from University Hospital Southampton showing it performed well during co-circulation of respiratory viruses (influenza, SARS-CoV-2, RSV), offering a high Negative Predictive Value (97-98%) across these pathogens. FebriDx supports antibiotic stewardship, ensuring that antibiotics are only prescribed when necessary, helping to combat AMR and optimize patient outcomes. Its role in primary care, pediatric settings, and emergency departments shows its versatility and real-world applicability in managing acute respiratory infections. For more details on how FebriDx contributes to the future of respiratory infection management, explore the research or reach out for further discussion. NIHR RSS Specialist Centre for Public Health (University of Southampton and Partners) Christopher Wilcox Victoria Trenchs Sainz de la Maza Dr Sally Fowler Davis

🌍 Navigating In Vitro Diagnostics (IVD) Reimbursement in Europe: The Key to Success for Startups 🧬 In the dynamic world of In Vitro Diagnostics (IVDs), it's not just innovation that sets a company apart—it's the ability to secure reimbursement that defines long-term success. In Europe, navigating the complex reimbursement landscape is essential to gaining market traction. Without a clear path to reimbursement, even the most groundbreaking technologies can struggle to find their place in clinical practice. At Odelle Technology, we've seen firsthand how strategic reimbursement pathways can make or break a product’s entry into the European market. Countries like France, Germany, and the UK have reimbursement systems that demand clinical evidence, cost-effectiveness analysis, and real-world data. Companies that master these processes ensure their innovations are adopted and unlock doors to broader healthcare opportunities. Startups like GRAIL (USA), QIAGEN (EU), Exact Sciences (USA), and Biocartis (EU) are leading the charge with innovative IVD solutions that promise to transform diagnostics. However, a solid reimbursement strategy is vital to ensure these technologies reach their full potential. At Odelle Technology, we specialize in guiding startups through this complex maze, from navigating early-stage reimbursement schemes to securing long-term market access. For startups breaking into the IVD space, now is the time to focus on more than just innovation. Reimbursement is not just a checkbox—it’s the foundation for achieving sustained clinical and commercial success in Europe. 🌱European Vaccines Diagnostics Abomics Oy(Finland) Chipmetrics (Finland) Genialis (Norway) GenomeMiner binx health(Sweden)Immunovia AB (Sweden)Prolight Diagnostics (Sweden) uFluidix (France)BforCure (France)Ziwig Biotech (France)Spindiag GmbH (Germany)Curetis GmbH (Germany)SphingoTec (Germany)STAT-Dx (Spain) Numares Health (Germany)Devicare (Spain)QuantuMDx (UK)Atlas Genetics GRAILGuardant HealthKariusHelixVeracyte, Inc.FreenomeBiodesix, Inc.GeneoscopyInivata Eurobiomed ScanBalt BioRegion #IVD #Reimbursement #Startups #Innovation#BIOTECHNOLOGY

Gonzalo Ladreda joins Steven Haken for this podcast. Gonzalo started his career very early in 2013 (18), as co-founder of Fresh! Clothing. Since January 2018, he has been part of the “Accelerate Program” at Cambridge Judge Business School. He has been named in the Forbes 30 under 30 Class of 2023 Europe for Science & Healthcare. Upfront Diagnostics, a company established in Cambridge (UK) in 2017, has developed rapid tests for identification of stroke patients. Within this podcast, Gonzalo discusses how the company was established and the need identified. He explains the new medical device, LVOne, that they have created to detect an LVO, bringing stroke diagnosis closer to the patient, and talks about the challenges experienced by MedTech startups, and how his company overcame those. Stroke Association Dr Tom French MBChB FRCP (Glasg) MRCP(UK)(AcuteMedicine) Stroke Association: Research Australian Stroke Alliance Edo Gaude Joshua Bernstock MD, PhD Ben Kemp British In Vitro Diagnostics Association (BIVDA) #podcast #medtech #stroke #heart #healthcare #innovation #health