US Settles Genetic Testing Fraud Case Against Laboratory Owner
The settlement follows a criminal conviction and addresses more than $174 million in fraudulent Medicare claims involving multiple laboratories.
Category: Molecular Diagnostics
Molecular Diagnostics
Latest
Molecular Diagnostics
Latest
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%.
Molecular Diagnostics
Latest
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.
New Data Supports Multi-Omic Blood Test for Early Ovarian Cancer Detection
AOA Dx presented data at AACR 2026 supporting its AKRIVIS GD Test System, a multi-omic, blood-based assay for early ovarian cancer detection in symptomatic women, reporting an AUC of 0.92 in clinical controls.
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A Urine Test That Could Help Predict Bladder Cancer Recurrence
Researchers have developed a urine-based liquid biopsy test that filters age-related mutations, potentially enabling more accurate prediction of bladder cancer recurrence and guiding immunotherapy decisions.
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New Cancer Guidelines Recommend Molecular Testing for All Pancreatic Cancer Stages
The NCCN now recommends comprehensive molecular profiling for all pancreatic cancer patients eligible for therapy, regardless of stage, to better guide targeted treatment and clinical trial enrollment.
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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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Illumina Partners with Florida State University Lab for Rare Disease Genome Sequencing
Illumina will provide clinical sequencing services to Florida State University’s new Diagnostic Lab for Pediatric Rare Diseases, aiming to accelerate rare disease diagnostics for an estimated 30 million affected Americans.
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Invivoscribe Launches Automated System Integrating Nucleic Acid Extraction and Quantification
Invivoscribe, in collaboration with Hitachi High-Tech, has launched the PrepQuant System, an automated platform that integrates nucleic acid extraction, concentration, and quantification to streamline molecular testing workflows.
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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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Singular Genomics Unveils Direct-Seq Technology for In Situ Sequencing of FFPE Samples
Singular Genomics introduced Direct-Seq technology for in situ sequencing of FFPE samples on its G4X platform and announced the SPOT-Met colorectal cancer study at AGBT 2026, analyzing 1,000 tumors using spatial multiomics.
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FDA Grants Breakthrough Designation to Breast Cancer Risk Assessment Test
The FDA has granted Breakthrough Device designation to PreludeDx’s AidaBREAST assay, which uses multi-omic data and AI to assess recurrence risk and radiation therapy benefit in early-stage invasive breast cancer.
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New Partnership Aims to Improve Early Alzheimer’s Disease Detection
Circular Genomics and Vitazi.ai have formed a partnership to combine AI-driven retinal imaging and blood-based RNA biomarkers for early Alzheimer’s disease detection, aiming to address gaps in early-stage patient identification.
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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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CareDx to Acquire Oncology Diagnostics Company Naveris for $160 Million
CareDx will acquire Naveris for $160 million, adding a Medicare-reimbursed liquid biopsy platform for viral-mediated cancer monitoring to its precision medicine portfolio.
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Illumina Partners Advance Cancer Research with Multiomics Technologies
Studies demonstrate spatial transcriptomics, 5-base sequencing, and proteomics applications in oncology diagnostics and therapeutic development.
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FDA Grants Breakthrough Status to Blood Test to Distinguish Schizophrenia and Bipolar Disorder
The mRNA-based test aims to provide objective data to help clinicians distinguish between psychiatric conditions that often share symptoms.
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