Medial EarlySign’s Post

Exciting times, part 2!   Early approval of “early detection”?   Some arguments pro and against faster approval of MCED tests from the transcript of the FDA, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, MOLECULAR AND CLINICAL GENETICS PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE’s meeting, November 29, 2023. https://lnkd.in/dDHmk9Ar    Experts including Philip E. Castle, Ph.D., M.P.H. and Ruth Etzioni Ph.D said the following:   - Seemingly good ideas may have no benefits or may rather harm, examples:   -- the UKCTOCS study (>200,000 women and 16 years follow-up): definitive evidence that ovarian cancer screening with CA125 and ultrasound does not „reduce deaths from ovarian cancer” „despite a 47.2% increase in incidence of stage I” and „24.5% decrease in those diagnosed with stage IV”   - PSA testing causes overdiagnosis: https://lnkd.in/dyatQ4AT   - Early detection of cancer is not the objective of colorectal screening for example – rather it is prevention of cancer, elimination of polyps     - If MCEDs are used, will people omit standard-of-care screening?    - Many cancers are not detected today and that is fine (indolent cancers).   On the other hand, GRAIL argues that compared to lung cancer screening, its Galleri test can detect 5 times as many cancers, and the number of positive results issued is just slightly more than that of a lung screening test. So, incredibly impressive numbers.   Dr. Josh Ofman, President of Grail says reduction in late-stage cancer incidents and sophisticated mortality modeling are their focus and a targeted diagnostic workup helps avoid overdiagnosis.   The FDA will have to decide on its approach and will also likely need to define a unified way of reporting performance data on MCEDs to allow for proper comparisons with each other and with standard-of-care screening methods.   Additionally, there is the question of the claim of "early detection": what data will be needed to substantiate the claim of "early detection," which, irrespective of the complexity of its meaning, may be the most important claim for marketing purposes.   #MCED #CancerScreening #05

AI FOR LUNG CANCER DIAGNOSIS: Who wants guesswork or 'assumption' involved in anything to do with their lungs? (I have had 3 different measurements, for ex, for lung nodules / masses on one lung since January. It is only late February. And the size variance is alarming.] The US lags behind the UK & EU in blood testing diagnostics for lung and other cancers, still. The Very First Thing You Should Know About CT Scans for Cancer Diagnosis Is This: A cancer diagnosis based on CT scan has the potential to be completely wrong – up to 30% of the time! That means that 30% of the time people will either be told they don’t have cancer when they do... or people will be told they do have cancer when they don’t, based on CT scans alone. -- CTOAM, a global, Canadian-based cancer care and precision oncology diagnositics foundation NIH says that in 2024 - US lung cancer misdiagnosis rates are 45.2% for men and 57.9% for women. (missed or misdiagnosed cancers) And, US criteria for what constitute's "HIGH RISK" lung cancer candidates - age and smoking, the litmus test for interpreting significance of xray or cat scan results - are inadquate. Leading causes of cancer are also attributed to air pollution, environmental exposure (radon), and genetic factors. If lung cancer in non-smokers was considered as a separate category, it would be the 7th most common cause of cancer deaths worldwide. SO IF YOUR PROVIDER WANTS TO ASSUME OR GUESS ABOUT RESULTS .. how do you owe it to yourself to respond? (If it were your CHILD, would you let any doctor get away with guesswork?) #lungcancer #precisiondiagnostics #NIH #AI

I am often asked about the value of real-world evidence (RWE) 📊. In 2019, my partner was diagnosed with colon cancer 🩻 and I became a caregiver. The irony of a loved one being diagnosed with the very tumor I have spent my career treating was profound. Suddenly, I was no longer just the oncologist prescribing anti-emetics 💊, but the caregiver witnessing how even mild nausea can be debilitating 😢. The decision between 3 versus 6 months of chemotherapy became a potentially life-altering choice 🤔. More treatment meant more potency but also more toxicities; less treatment meant better tolerability but possibly less effectiveness. In our latest RWE study 🔬, Samnani et al. tackled this pragmatic clinical question. We found that shorter durations of adjuvant chemotherapy 💉 in a real-world population of patients with low-risk stage 3 colon cancer have been widely adopted in routine practice, with no significant detriment on survival 👍🏼 — confirming earlier results from the IDEA collaboration with highly selected clinical trial participants 🩺. This is the power of RWE 💪🏼. It demonstrates that less can be more. It addresses challenging clinical scenarios. It includes everyone. It matters to patients and caregivers. And for me and many others, it is deeply personal ❤️. #realworlddata #RWD #realworldevidence #RWE Oncology Outcomes (O2) Inka Health

If you have heard about time toxicity in oncology care, this manuscript shows a great example. 1 in 3 days at the end of life involved contact with the healthcare system. Even patients not having systemic therapy had significant interactions with the healthcare system. Patients value time at home with family, and so should the healthcare delivery system. #marketaccess https://lnkd.in/gvtJfNB3.

🔬 Delving into the forefront of healthcare innovation! 🎯 Precision medicine offers tailored treatment strategies, leveraging genetic insights to personalize therapies and enhance outcomes for cancer patients. 🛡️ However, ensuring the safety and well-being of patients amidst this transformative journey is paramount. Key Focus Areas: 📌 Rigorous patient screening and selection criteria to mitigate potential risks. 📌 Ongoing monitoring and surveillance protocols to track treatment efficacy and adverse effects. Multidisciplinary collaboration among healthcare professionals to optimize patient care and support. 🔖 Read more at https://lnkd.in/d2EFfdjj #PrecisionMedicine #CancerCare #PatientSafety #HealthcareInnovation #Oncology

Uncover the essential steps to quality improvement in cancer care with our latest coverage from Association of Cancer Care Centers’ 50th Annual Meeting & Cancer Center Business Summit. Explore actionable insights and strategies to enhance patient outcomes and streamline health care delivery here: #AMCCBS24

Researchers from The Institute for Digital Medicine (WisDM) at #NUSMedicine, led by Professor Dean Ho, are revolutionising treatment for rare diseases with a groundbreaking approach. By harnessing the power of the AI-driven platform CURATE.AI, the team successfully guided the treatment of a patient with Waldenströmmacroglobulinemia—a rare blood disorder affecting just 3 in 1,000,000 people annually—using individualised data from the patient, based on drug dose responses. Since the trial began in October 2021, the patient's condition has significantly improved without the need for blood transfusions or serious side effects. 💉✨ This pioneering trial, in collaboration with the National University Cancer Institute, Singapore (NCIS), has not only optimized the patient's drug dosage but also reduced treatment costs by USD 8,000 (SGD 10,500) over two years. Find out more here: https://lnkd.in/gNP5wmbP #HealthcareInnovation #RareDiseases #DigitalMedicine #AIInHealthcare #PrecisionMedicine #NUSMedicine #NewsandUpdates #InspiringInnovators

Three #cartcelltherapy #clinicaltrials reported this week #inspire #hope to recurrent #glioblastoma (#braintumor) patients. These phase 1 CAR-T trials were designed against two commonly #overexpressed #proteins in glioblastoma, the epidermal growth factor receptor variant III (#EGFRvIII) and interleukin-13 receptor alpha 2 (#IL13Rα2). Stephen Bagley's team from University of Pennsylvania Perelman School of Medicine used a dual-target CAR-T against these proteins (#EGFRvIII and #IL13Rα2) and injected them into #CSF so that the #cartcells could reach to the #braintumor cells directly. Early trail results from 6 #patients were released and MRI results after 24 to 48 hours post-administration revealed #reduced #tumor sizes in all 6 patients. Christine Brown's group from City of Hope reported data from a completed phase-I trial of 65 patients having recurrent high-grade glioma with CAR-T targeting #IL13Rα2. The trial evaluated 3 #routes (#intratumoral, #intaventricular and both) and #Stable disease or better was achieved in 50% of patients. Bryan Choi's group from Mass General Cancer Center used #EGFRvIII targeting #cartcelltherapy and released data from 3 recurrent glioblastoma patients. Named CARv3-TEAM-E T cells, these CAR-Ts targeted #EGFRvIII as well as wild-type #EGFR #protein through secretion of a T-cell–engaging antibody molecule (#TEAM) and was delivered through #intraventricular route. #Radiographic #tumor #regression was rapid and dramatic, however, responses were transient in two out of three patients. The First two reports were published in #Nature #Medicine and the third was published in #New #England #Journal of #Medicine. https://lnkd.in/gBuW8c_3 https://lnkd.in/gqSsps5k https://lnkd.in/gbKT3zCx https://lnkd.in/grhJCBns

In this The Medicine Maker article, Sam Clark, MD PhD, and other biotech leaders share their insights on R&D for Alzheimer’s disease (AD). The experts discuss the successes and setbacks of AD treatment prospects, recent promising innovations, and their predictions for the future of AD treatment. Terran is excited to be pressing forward with therapeutics and technologies that could benefit patients with AD.   “I envision a future where AD is more similar to a treatable cancer than the slow, devastating, and inevitable decline that patients face today. Between innovations in the diagnosis of AD pathology and in the development of treatments that effectively target the mechanisms driving the disease, it is not implausible to believe we can reach this point.” - Sam Clark, MD, PhD   Read the full article here: https://lnkd.in/gJbAGXvf #Alzheimersdisease #Alzheimers

Certainly Covid testing was ramped up quickly with an acute pandemic. We have the capacity to ramp up testing quickly, sometimes without the long time it takes to adequately vet the testing the way we would ideally wish. Maybe 3rd party payment is awaiting long term studies but some think financially viable testing can be made available and affordable as self pay now. This is how pharmacogenomics (PGx) testing started. We are now getting better payment and those of us who have been using this testing for years now have seen its value.