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Biocartis Achieves First IVDR Class C Companion Diagnostic Certification for EGFR Mutation Test in Europe

Precision Medicine
  • Biocartis' Idylla™ EGFR Mutation Test becomes the first test in the company's portfolio to receive IVDR Class C companion diagnostic certification in Europe.
  • The test detects 44 EGFR mutations in under 3 hours with 99.2% sensitivity and 99.0% specificity for key biomarkers guiding NSCLC treatment decisions.
  • The certification enables European availability of the automated diagnostic platform, while US development continues in partnership with AstraZeneca for Tagrisso treatment selection.

Oxford Cancer Biomarkers Partners with Mira Precision Health to Advance ToxNav® Test for 5FU/Capecitabine Toxicity Prediction in US Market

Precision Medicine
  • Oxford Cancer Biomarkers has partnered with Mira Precision Health to advance its ToxNav® test in the United States, a precision oncology diagnostic that identifies patients at high risk of severe toxicity from 5FU/capecitabine treatment.
  • The ToxNav® test enhances clinical decision-making through comprehensive genetic profiling and aligns with recent NCCN Guidelines updates recommending DPYD testing for colorectal cancer patients receiving fluoropyrimidine-based treatments.
  • The partnership aims to establish substantial market presence in the US, with ToxNav® already backed by multiple peer-reviewed studies and CE-IVD certification in the UK, potentially saving patient lives by preventing avoidable treatment toxicity.

Viz.ai Partners with Novartis to Develop AI-Powered Cancer Care Solutions for Prostate and Breast Cancer

AIOncologyPrecision Medicine
  • Viz.ai and Novartis announced a multi-year strategic collaboration to develop AI-powered workflows within the Viz Oncology Suite, focusing on prostate and breast cancer patient identification and care coordination.
  • The partnership will create two new solutions: Viz Prostate Cancer to streamline patient identification for guideline-based treatments, and Viz Breast Cancer to automate patient review and facilitate multidisciplinary care coordination.
  • The collaboration addresses critical gaps in cancer care, as only one in four prostate cancer patients receive guideline-recommended therapy, while breast cancer remains the most widely diagnosed cancer in the United States with complex care journeys.
  • This strategic alliance marks Viz.ai's expansion into oncology, building on their AI-powered disease detection platform that currently serves over 1,700 hospitals and health systems across the U.S. and Europe.

Relay Therapeutics Reports Sustained Efficacy for RLY-2608 in PI3Kα-Mutated Breast Cancer at ASCO 2025

Precision Medicine
  • Relay Therapeutics presented updated interim data for RLY-2608 plus fulvestrant showing consistent median progression-free survival of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.
  • The first-in-human ReDiscover study enrolled 118 patients, with RLY-2608 demonstrating a favorable tolerability profile including 92% median dose intensity and only 36% experiencing Grade 3 treatment-related adverse events.
  • The company plans to initiate the pivotal Phase 3 ReDiscover-2 trial in mid-2025, marking the first mutant-selective PI3Kα inhibitor to advance to Phase 3 testing.
  • RLY-2608 represents a novel allosteric, pan-mutant, and isoform-selective approach to PI3Kα inhibition, potentially addressing over 300,000 patients annually in the United States.

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521Not Yet RecruitingPhase 3
Relay Therapeutics, Inc.
Posted 7/31/2025

Mirvie's RNA Blood Test Predicts Preeclampsia Risk Months Before Symptoms in Major Study

Precision Medicine
  • Mirvie's blood test successfully identified 91% of preterm preeclampsia cases in women over 35 without pre-existing conditions, using RNA signatures detectable at 17.5-22 weeks gestation.
  • The study analyzed over 9,000 pregnancies and discovered molecular signatures that distinguish between severe and mild hypertensive disorders of pregnancy for the first time.
  • Preeclampsia rates have nearly doubled in the past decade, now affecting 1 in 12 pregnancies, highlighting the urgent need for better predictive tools.
  • The clinically validated test will be available under the Encompass brand, enabling proactive care plans including low-dose aspirin therapy months before symptoms appear.

Artera's AI Algorithm Identifies Which Prostate Cancer Patients Benefit from Intensive Therapy, Earning Best of ASCO Recognition

AIPrecision Medicine
  • Artera's multimodal AI algorithm successfully identified that only 25% of high-risk prostate cancer patients derive meaningful benefit from androgen receptor pathway inhibitor intensification, potentially sparing 75% from unnecessary toxicities.
  • The company's oral presentation was selected for Best of ASCO 2025, representing the first validated AI algorithm to personalize treatment decisions for high-risk, non-metastatic prostate cancer patients.
  • The ArteraAI Prostate Test works with routine pathology and clinical data without requiring extra tissue or complex molecular testing, making it broadly scalable and cost-effective for clinical implementation.

14-Gene Molecular Assay Guides Adjuvant Chemotherapy in Early-Stage NSCLC, Reduces Recurrence Risk by 78%

Precision Medicine
  • The AIM-HIGH trial demonstrated that a 14-gene molecular assay (RiskReveal) can identify patients with stage IA-IIA nonsquamous NSCLC who benefit from adjuvant chemotherapy, showing a 78% reduction in recurrence risk.
  • Patients classified as high or intermediate risk by the assay achieved 96% disease-free survival at 24 months with chemotherapy versus 79% with observation alone (HR 0.22, P=0.0087).
  • This represents the first prospective randomized trial to show improved disease-free survival using molecular risk stratification in early-stage nonsquamous NSCLC, potentially changing treatment paradigms for patients not typically offered adjuvant therapy.
  • The trial was stopped early by the data safety monitoring board due to significant efficacy differences, with similar benefits observed even in stage IA disease patients (98% vs 78% DFS, P=0.0345).

Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer: AIM-HIGH (Adjuvant Intervention in Molecular High Risk Patients)

NCT01817192Active, Not RecruitingNot Applicable
Razor Genomics
Posted 9/11/2020

Frontotemporal Dementia Therapeutics Enter New Era as Gene and Antibody Therapies Advance Toward Market

Monoclonal AntibodyOrphan DrugPrecision Medicine
  • Alector's Latozinemab (AL001) leads the frontotemporal dementia pipeline as a monoclonal antibody targeting progranulin deficiency, currently in pivotal Phase III trials with potential approval by 2026-2027.
  • Gene therapy companies AviadoBio and Passage Bio are developing AAV-based treatments AVB-101 and PBFT02 to restore progranulin expression through one-time administration, with readouts expected in late 2027 or early 2028.
  • The FTD therapeutic landscape is shifting from symptom management to disease modification, with multiple approaches including monoclonal antibodies, gene therapies, and oral small molecules targeting genetic biomarkers.
  • By 2028, the FTD market may include personalized therapies aligned with genetic profiles, potentially transforming clinical outcomes for patients aged 45-64 who currently lack disease-modifying treatment options.

Cofactor Genomics' AI-Powered RNA Platform Shows 300-400% Improvement in Predicting Cancer Immunotherapy Response

AIPrecision Medicine
  • Cofactor Genomics' OncoPrism platform demonstrates 300-400% improvement in predicting patient responses to cancer immunotherapies compared to other clinical tests using AI and RNA expression data.
  • The company presented first-time validation results for OncoPrism-NSCLC, showing superior performance over PD-L1 testing with higher sensitivity and specificity in non-small cell lung cancer patients.
  • OncoPrism-HNSCC and OncoPrism-NSCLC are now available for clinical use from Cofactor's CAP-accredited, CLIA-certified laboratory, with Medicare reimbursement approval secured for the head and neck cancer version.

Illumina Launches PromoterAI Tool to Detect Disease-Causing Mutations in Previously Overlooked Genomic Regions

AIRare DiseasePrecision Medicine
  • Illumina has introduced PromoterAI, an AI tool that detects disease-causing mutations in noncoding promoter regions of the genome, areas typically overlooked in clinical diagnostics.
  • The breakthrough technology, featured in Science, could explain up to 6% of undiagnosed rare disease cases and potentially double diagnostic success when combined with existing AI tools.
  • PromoterAI analyzes promoter sequences using deep learning and is freely available for academic research through Illumina Connected Software, offering precomputed scores to prioritize harmful mutations.
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