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Agilent's MMR IHC Panel PharmDx Receives FDA Approval as Companion Diagnostic for Colorectal Cancer Immunotherapy

FDA ApprovalPrecision Medicine
  • Agilent Technologies received FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic test to identify mismatch repair deficient colorectal cancer patients eligible for Bristol Myers Squibb's Opdivo immunotherapy treatments.
  • The test detects loss of function in four key mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6) in colorectal cancer tissue, making it the only FDA-approved companion diagnostic IHC panel for this specific indication.
  • This diagnostic tool enhances healthcare providers' ability to tailor immunotherapy treatments for colorectal cancer patients, potentially improving tumor control and progression-free survival outcomes.

BeginNGS Newborn Genome Screening Program Expands to Qatar in First International Collaboration

Precision Medicine
  • Rady Children's Institute for Genomic Medicine announced a collaboration with Sidra Medicine in Qatar to implement the BeginNGS genome-based newborn screening program internationally.
  • The partnership aims to screen newborns for over 1,000 treatable genetic disorders, building on Qatar's existing NOOR project for large-scale newborn genome screening.
  • BeginNGS technology reduces false positives by 97 percent and benefits one in 13 infants, currently screening for 511 severe childhood genetic diseases across multiple US hospitals.
  • The collaboration supports the program's goal of implementing screening for 1,000 diseases in at least 10 countries by 2030.

Atropos Health and Novartis Partner to Deploy AI for Faster Rare Disease Diagnosis in PNH Patients

AIRare DiseaseReal World EvidencePrecision Medicine
  • Atropos Health has partnered with Novartis to develop AI models that identify undiagnosed patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder affecting 10-20 people per million worldwide.
  • The collaboration addresses critical diagnostic delays in PNH, where many patients wait over a year for diagnosis and some wait more than five years due to the disease's rarity and varied symptoms.
  • The AI model, trained on real-world data from the Atropos Evidence Network, is now available for integration into health systems to accelerate appropriate diagnosis at the point of care.
  • The partnership aims to reduce time from initial symptoms to testing, diagnosis and treatment by implementing patient-finding models across health system members of the Atropos Evidence Network.

Oman Achieves Medical Milestone with First Successful CAR-T Cell Therapy Implementation

CAR-TPrecision Medicine
  • The University Medical City in Oman successfully implemented the first CAR-T cell therapy in the Sultanate, positioning the country among regional leaders in advanced blood cancer treatment.
  • The therapy has demonstrated remarkable response rates in patients with B-cell Acute Lymphoblastic Leukemia and Diffuse Large B-cell Lymphoma, particularly for those unresponsive to conventional treatments.
  • This achievement results from collaboration between national medical teams and international partners, marking a significant step toward medical self-sufficiency and reduced overseas treatment costs.
  • The implementation represents a pioneering milestone in localizing cutting-edge immunotherapy previously available only at select international centers.

ViewsML and iProcess Form Strategic Partnership to Accelerate AI-Powered Virtual Biomarker Testing

AIPrecision Medicine
  • ViewsML, a pioneer in AI-powered virtual immunohistochemistry staining, has partnered with iProcess Global Research to expand access to virtual biomarker technology across research institutions and pharmaceutical companies.
  • The collaboration enables customers to eliminate physical biomarker staining, dramatically accelerating turnaround times from days to seconds while preserving rare tissue samples for multiplex analysis.
  • ViewsML's platform predicts biomarker expression at the per-cell level using only a single H&E image, fitting seamlessly into existing pathology workflows for research and diagnostic applications.
  • The partnership addresses growing demand for faster, more scalable, and cost-effective biomarker analysis, particularly in early drug discovery and high-throughput settings.

Phase III IMvigor011 Trial Demonstrates Significant Survival Benefits for ctDNA-Guided Bladder Cancer Treatment

Precision Medicine
  • The randomized phase III IMvigor011 trial achieved positive topline results, showing statistically significant and clinically meaningful improvements in disease-free survival and overall survival for Signatera-positive muscle-invasive bladder cancer patients treated with atezolizumab.
  • This represents the first prospective phase III study in muscle-invasive bladder cancer to use a personalized, ctDNA molecular residual disease-guided approach for treatment selection.
  • Signatera-negative patients demonstrated excellent outcomes without adjuvant treatment, with 100% overall survival at 12 months and 98% at 18 months.
  • Natera plans to finalize its premarket approval application to the FDA for Signatera as a companion diagnostic for selecting MIBC patients for atezolizumab treatment after cystectomy.

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

NCT04660344Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/3/2021

KIFFIK Biomedical Strengthens Leadership with Strategic Appointments to Advance Interstitial Fluid Diagnostics

Precision MedicineOncology
  • KIFFIK Biomedical appointed Rene Veloso as Chief Investment Officer to secure capital investments for interstitial fluid real-time monitoring applications in cancer and other diseases.
  • Dr. Reginald Swift, CEO of Rubix Life Sciences, joined as fractional Chief Scientific Officer to shape clinical operations and ensure R&D activities meet highest scientific standards.
  • The company's proprietary KIFFIK EXP platform offers needle-free, real-time diagnostics for oncology and therapeutic monitoring through interstitial fluid-based biomarker detection.
  • KIFFIK previously established a strategic partnership with Rubix Life Sciences to advance next-generation ISF extraction technology using aptamer-based precision medicine approaches.

Caris Life Sciences Study Reveals Optimal Sequencing Strategy for Antibody-Drug Conjugates in HER2-Negative Breast Cancer

Precision MedicineReal World Evidence
  • Caris Life Sciences published a real-world evidence study in Breast Cancer Research comparing trastuzumab deruxtecan and sacituzumab govitecan in over 4,000 HER2-negative breast cancer patients.
  • The study found that trastuzumab deruxtecan demonstrated superior treatment duration for hormone receptor-positive patients, while sacituzumab govitecan showed better first-line results in HR-negative and HER2-null tumors.
  • Both antibody-drug conjugates provided comparable benefits in triple-negative breast cancer patients, highlighting the importance of personalized treatment strategies based on tumor subtype.
  • The research addresses the absence of head-to-head clinical trials between the two most commonly used ADCs in breast cancer treatment.

Oxford BioDynamics Partners with Google Cloud to Scale AI-Powered 3D Genomic Analytics Platform

Precision Medicine
  • Oxford BioDynamics has partnered with Google Cloud to expand its 3D genomic biomarker technology capabilities through cloud-based infrastructure and AI-powered analytics.
  • The collaboration will enable OBD to scale its proprietary EpiSwitch knowledge base and analytical tools to provide high-throughput genomic analytics to pharmaceutical and biotechnology partners.
  • Google Cloud's infrastructure will support containerized applications, AI/ML tools integration, and secure data processing pipelines that meet healthcare compliance standards.
  • The partnership aims to accelerate access to predictive genomic insights for drug development and diagnostics through real-time 3D genomics analysis.

Tahoe Therapeutics Secures $30M to Create World's Largest Single-Cell Dataset for AI-Driven Drug Discovery

AIPrecision MedicineDrug Discovery
  • Tahoe Therapeutics raised $30 million in Series A funding led by Amplify Partners to build a one billion single-cell datapoint dataset for training Virtual Cell Models.
  • The company's previous Tahoe-100M dataset has been downloaded nearly 100,000 times and already led to discovery of promising therapeutic candidates for major cancer subtypes.
  • The new dataset will map one million drug-patient interactions and aims to reduce clinical trial failure rates while accelerating precision medicine development.
  • Tahoe plans to select a single strategic partner to access the dataset and collaborate on developing the first medicines powered by virtual cell models.

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