MAYO CLINIC

Mayo Clinic study finds half of participants unaware of genetic cancer risks, suggesting current screening guidelines are inadequate.

In a roundtable discussion on diversity in clinical research, experts highlighted challenges like historical mistrust, access issues, and eligibility criteria. They emphasized the need for early diversity planning, better technology integration, and consistent funding to enhance DE&I.

Blood tests for Alzheimer’s are ready, with many plasma p-tau217 assays meeting triage criteria and several vendors filing for FDA approval. CMS may reimburse, but rates are uncertain. Vendors like Fujirebio and Roche have filed for IVD approval, and leaders in AD drug development await regulatory approval. The CEOi panel recommends tests with 90% sensitivity and 85% specificity, prompting vendors to optimize their tests. The p-tau217/Aβ1-42 ratio outperforms p-tau217 alone in identifying amyloid-positive individuals, with fewer indeterminate results. Post-approval, integration into clinical practice and appropriate-use recommendations are crucial.

Ozempic, a diabetes medication turned weight-loss drug, has severe side effects like stomach paralysis, mental health complications, and gastrointestinal distress. It's linked to pancreatitis, kidney problems, and thyroid tumors, with potential for pulmonary aspiration during surgery. Despite benefits, side effects must be discussed with healthcare experts.

Cardiol Therapeutics announced Phase II MAvERIC-pilot study results showing sustained improvements in pericarditis pain and inflammation with CardioRx. The study enrolled 27 participants, with data supporting the initiation of a Phase III trial. Analysts maintain positive ratings, highlighting the drug's sustained efficacy and safety. The global cardiovascular drugs market is projected to grow significantly by 2033.

Veravas developed the VeraBIND Tau Assay, a blood test showing 92% agreement with tau PET imaging for Alzheimer's tau pathology, aiming to improve diagnostic accuracy and potentially delay disease onset.

icobrain aria, an AI-driven MRI software, aids radiologists in detecting ARIA in amyloid immunotherapy patients, improving accuracy for ARIA-E and ARIA-H detection. FDA approved for clinical use on November 7, 2024.

EndoQuest Robotics submitted an IDE application for its pivotal colorectal clinical study, aiming to transform MIS with its flexible robotic system. The PARADIGM study, enrolling 50 subjects at five US facilities, will evaluate the ELS System's efficacy in robotic ESD procedures for colorectal lesions. Pre-clinical data showed superior outcomes and reduced procedure time. The IDE is pending FDA approval, expected within 30 days.

The FDA granted breakthrough therapy designation to nipocalimab (Johnson & Johnson) for treating moderate-to-severe Sjögren disease (SjD), the first for this condition. SjD, a chronic autoantibody disease, primarily causes dry eyes and mouth, often coexisting with rheumatoid arthritis and lupus. Nipocalimab, an FcRn blocker, showed positive results in a phase 2 study, with improvements in disease activity and symptoms like dryness. A phase 3 study is ongoing, aiming to address the disease's underlying causes and improve patient outcomes.

Cardiol Therapeutics' CardiolRx™ showed significant improvements in pericarditis pain and inflammation in a phase II trial, supporting planned Phase III trials for prevention of recurrence. The drug was safe and well-tolerated, with potential to offer a more accessible treatment option for pericarditis patients.