Automated Cytomegalovirus PCR Assay Receives IVDR Certification for Transplant Care
The test allows for simultaneous detection of multiple viruses on a sample-to-answer platform designed for immunocompromised patients.
Tag: molecular diagnostics
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Next-Generation Sequencing Library Prep System for Lower-Throughput Labs Launches
n6 has launched the icon16, a 16-well NGS library prep instrument for low-throughput clinical and research labs, featuring per-well real-time amplification control using the company’s AutoNorm technology.
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Hepion Pharmaceuticals Licenses ctRNA Biomarker Assay for Liver Cancer Detection
Hepion Pharmaceuticals has licensed a circulating tumor RNA assay from Cirna Diagnostics for early detection of hepatocellular carcinoma in high-risk patients, expanding its liquid biopsy portfolio for liver cancer.
Mursla Bio Joins ABHI US Accelerator Program to Launch Liver Cancer Test
Mursla Bio has joined the ABHI US Accelerator program to support the US launch of EvoLiver, an FDA-designated liver cancer surveillance test, gaining access to 300-plus healthcare leaders across 35 hospitals and 20 health systems.
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Blood Test for Endometriosis Detection Now Available at IVF Centers
HerAnova Lifesciences has launched HerResolve, the first blood-based test for endometriosis detection, at IVF centers nationwide. Validation studies show diagnostic accuracy comparable to surgical standards, according to the company.
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Medicare Part B Lab Test Spending Rises 5% in 2024, Driven by Genetic Tests
Genetic tests accounted for 43% of all Part B lab spending despite representing only 5% of tests performed, according to HHS OIG data.
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Study Finds Test Helps Distinguish Infection From Inflammation in Bone Marrow Transplant Patients
Research in bone marrow transplant patients with blood cancers and febrile neutropenia suggests the host-response test may help identify infection in high-risk populations.
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FDA Grants Breakthrough Status to Breath Test for Postoperative Pneumonia Risk
The FDA has granted Breakthrough Device Designation to Breath Diagnostics Inc.’s OneBreath, a breath-based test that assesses postoperative pneumonia risk in cardiac surgery patients using a single preoperative sample.
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Illumina Announces NovaSeq X Performance Upgrades Including Q70 Quality Scores
Illumina has announced an 18-month roadmap for NovaSeq X, featuring a 40% output increase to 35 billion reads, faster turnaround times, new flow cell options, and the introduction of Q70 quality scores.
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NeoGenomics Launches PanTracer Pro for Solid Tumor Testing
The integrated testing approach combines genomic profiling with immunohistochemistry to support faster treatment decisions for advanced-stage cancer patients.
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New ctDNA Assay Aims to Detect Molecular Residual Disease Earlier in Solid Tumors
Tumor-informed blood test uses whole-exome sequencing and bioinformatics to identify trace tumor DNA before recurrence appears on imaging.
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Syndex Bio Unveils DNA Methylation Technology After $15.5M Funding Round
The mcPCR platform enables copying of DNA methylation patterns during amplification, addressing a key limitation in current PCR methods for disease detection.
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CDC Selects Cepheid as National Collaborator for Rapid Diagnostic Development
The CDC has named Cepheid one of four national collaborators to accelerate rapid diagnostic assay development for public health emergencies under a new federal initiative and IDIQ contract.
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Illumina Secures CMS Reimbursement for TruSight Oncology Test
Illumina’s FDA-approved TruSight Oncology test will be reimbursed by CMS at $2,989.55 per test starting Jan. 1, 2026, enabling broader laboratory access to genomic profiling for Medicare beneficiaries.
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Blood Test Could Detect Parkinson’s Disease Before Symptoms Appear
Researchers have identified blood biomarkers that may enable detection of Parkinson’s disease up to 20 years before symptoms.
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Circular Genomics Secures Exclusive Rights to Blood Test Technology for Alzheimer’s Disease
Circular Genomics has secured exclusive rights from Washington University and Max Delbrück Center to develop a blood-based Alzheimer’s test using circular RNA biomarkers.
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BillionToOne Launches Two Liquid Biopsy Add-On Tests for Cancer Therapy Selection
BillionToOne has launched Northstar PGx and Northstar Select CH, two liquid biopsy add-on tests for advanced solid tumor therapy selection, enabling pharmacogenomic insights and clonal hematopoiesis detection from a single blood draw.
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Blood Test Detects Early-Stage Cancer Using DNA Methylation Patterns
Johns Hopkins researchers have developed a liquid biopsy that detects early-stage lung and breast cancers by measuring DNA methylation variation, showing high accuracy in a study published in Clinical Cancer Research.
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