City of Hope Developing Blood Test for Early Colorectal Cancer Detection
The screening tool aims to identify the disease in adults under 50, a population experiencing a significant increase in cases.
Tag: molecular diagnostics
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Can a Blood Test Identify Head and Neck Cancer Patients at Risk of Recurrence?
An experimental assay detected residual HPV-related cancer DNA after surgery and was associated with poorer outcomes in an observational study.
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Study Shows Blood Test Predicts Breast Cancer Recurrence Years Before Clinical Symptoms
Monitoring circulating tumor DNA dynamics outperformed standard markers for predicting survival and relapse in early-stage patients.
FDA Clears Customizable Gastrointestinal Pathogen Assay
Diasorin has received FDA 510(k) clearance for its customizable LIAISON PLEX Gastrointestinal Flex Assay, allowing labs to select from 24 targets to tailor testing based on patient needs and operational priorities.
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Blood Test Outperforms Ultrasound in Early Liver Cancer Detection, Study Finds
A multicenter clinical trial found the HelioLiver blood test detected early-stage liver cancer with 71.9% sensitivity, outperforming ultrasound’s 36.8%.
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Genotyping Assay That Identifies Genetic Risk for Chemotherapy Side Effects Launches
Yourgene Health has launched the Yourgene Insight DPYD assay, expanding detection to 19 variants for DPD deficiency screening in cancer patients receiving 5-fluorouracil, with same-day results and initial Research Use Only availability.
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Medicare Expands Coverage for Cancer Immunotherapy Monitoring Test
CMS has expanded Medicare coverage for Personalis’ NeXT Personal MRD test, now allowing immunotherapy monitoring in late-stage solid tumor patients, supported by recent clinical evidence from Vall d’Hebron Institute of Oncology.
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Amplified Sciences Launches Study for Pancreatic Cyst Diagnostic Assay
Amplified Sciences has launched the PanAMP multicenter study to assess how its PanCystPro assay impacts clinical management decisions for patients with radiographically confirmed pancreatic cystic lesions.
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Eurofins Companies Develop Diagnostic Solutions for Hantavirus Outbreak
Eurofins companies are developing molecular and serological tests to monitor a hantavirus outbreak linked to the Andes strain, with 11 cases and three deaths reported as of May 12.
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Cyted Health US Laboratory Earns CAP Accreditation
The gastrointestinal molecular diagnostics company’s facility adds College of American Pathologists accreditation to its existing CLIA certification.
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Low-Cost Blood Test Detects Multiple Cancers and Liver Diseases, Study Finds
Researchers at UCLA have developed a low-cost blood test, MethylScan, that detects multiple cancers and liver diseases by analyzing DNA methylation patterns in cell-free DNA.
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Bruker Launches High-Throughput Molecular Diagnostic System for Infectious Diseases in Europe
Bruker has launched the MyGenius PRO molecular diagnostics system in Europe, offering fully automated, high-throughput PCR testing for infectious diseases with an initial focus on CMV, EBV, and BKV assays for clinical labs.
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Portable Tuberculosis Test Matches Laboratory Accuracy in Minutes, Study Finds
A study finds the battery-powered MiniDock MTB delivers lab-accurate tuberculosis results from tongue swabs in under 30 minutes.
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ClearNote Health to Present Pancreatic Cancer Test Data at DDW 2026
ClearNote Health will present data at DDW 2026 showing its Avantect Pancreatic Cancer Test achieved 82.6% sensitivity and 97.5% specificity in patients at elevated risk.
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New Clinical Data Supports Blood-Based Monitoring for Cancer Treatment Response
Personalis presented data at AACR showing its NeXT Personal assay enabled ultrasensitive ctDNA monitoring for colorectal and lung cancer patients, demonstrating 100% sensitivity at baseline and 100% specificity for relapse post-surgery.
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Study Finds Undiagnosed Tuberculosis DNA in US Patients Using Ultrasensitive Test
A Boston University study found TB DNA in 12% to 16% of respiratory samples from hospitalized patients in a low-incidence area using an ultrasensitive assay, suggesting underdiagnosis of tuberculosis in the US.
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Watchmaker Genomics Launches Molecular Kits Aimed at Faster Point-of-Care Results
Watchmaker Genomics has launched new RT-qPCR and qPCR kits, enabling assay developers to create rapid, robust point-of-care and field-deployable molecular diagnostic tests, with results in under 10 minutes.
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CSF Liquid Biopsy May Improve Diagnosis of Leptomeningeal Disease
A study reports that CSF liquid biopsy measuring variant allele frequency may improve leptomeningeal disease diagnosis, especially when MRI and cytology are inconclusive.
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