Ambry Genetics Launches Whole Genome Sequencing Test Solution for Rare Diseases
The new testing solution integrates ongoing data reanalysis to re-evaluate variants as clinical gene-disease knowledge expands.
Category: Molecular Diagnostics
Molecular Diagnostics
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Molecular Diagnostics
Latest
Renew Biotechnologies, Mayo Clinic Partner to Evaluate cfDNA Biomarker in Multiple Sclerosis
Renew Biotechnologies and Mayo Clinic have partnered to evaluate NeuroLens, a cfDNA-based test, for monitoring central nervous system injury and disease progression in multiple sclerosis and related neuroimmunologic conditions.
Molecular Diagnostics
Latest
Combining p-tau217 Blood Tests with APOE4 Genotyping Forecasts Alzheimer’s Symptom Onset, Study Finds
A Columbia University study finds that combining plasma p-tau217 blood tests with APOE4 genotyping can predict Alzheimer’s symptom onset within three to four years in high-risk, asymptomatic individuals.
Genetic Tests Used Before Lamotrigine May Miss Severe Reaction Risk
A Vanderbilt study finds that standard genetic tests for lamotrigine reaction risk omit HLA-A*32:01, a marker linked to severe DRESS, raising concerns about current pharmacogenomic panel effectiveness.
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BillionToOne Launches Liquid Biopsy Test to Identify Cancer Tissue of Origin
BillionToOne has launched Northstar Origin, a liquid biopsy add-on that predicts cancer tissue of origin from cell-free DNA, and expands its genomic profiling panel to 102 genes.
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QIAGEN Launches QIAsymphony Connect for Automated Nucleic Acid Extraction
QIAGEN has launched QIAsymphony Connect, an IVD-compliant platform for automated nucleic acid extraction, supporting up to 96 samples per run and compatible with existing QIAsymphony reagents and consumables.
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Whole Blood Could Expand Clinical Biomarker Discovery
Researchers have optimized the PROSPR method to isolate extracellular vesicles directly from whole blood, revealing protein and lipid signatures not detected in plasma.
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Ultrasonic Blood Test Method Shows High Accuracy for Alzheimer’s Detection
Researchers at Xuanwu Hospital have developed an ultrasonic blood test method that detects Alzheimer’s with over 90% accuracy by measuring plasma amyloid-beta seeding activity.
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2,000-Patient Lung Cancer Project Turns to Liquid Biopsy for Genomic Screening
Pillar Biosciences, LC-SCRUM-Asia, and LSI Medience will collaborate on a two-year, 2,000-patient liquid biopsy lung cancer screening project in Japan, using cfDNA and cfRNA testing.
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Artificial Intelligence Models Predict Organ-Specific Aging from Blood Samples
Researchers at CeMM and the Ludwig Boltzmann Institute have developed AI-based “tissue clocks” that estimate organ-specific biological age from blood samples, potentially improving chronic disease monitoring, according to a Nature Medicine study.
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NIAID Awards Zepto Life Technology Up to $8.9 Million for Liquid Biopsy Platform
Zepto Life Technology received up to $8.9 million from NIAID to develop a plasma cell-free DNA liquid biopsy platform aimed at improving diagnosis of invasive fungal infections.
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FDA Clears QIAGEN Bloodstream Infection Panel
QIAGEN has received FDA clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, enabling detection of 20 pathogens and 10 antimicrobial resistance markers from positive blood cultures in about one hour.
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FDA Advisory Committee to Review GRAIL Multi-Cancer Early Detection Test
The FDA will review GRAIL’s Premarket Approval application for the Galleri multi-cancer early detection blood test on Sept 23, 2026, evaluating data from the PATHFINDER 2 and NHS-Galleri studies.
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Study Details New ctDNA Isolation Method for Liquid Biopsy
VolitionRx has published peer-reviewed data on its Capture-Seq technology, reporting over 99% pure ctDNA isolation from plasma and 95% detection of early-stage cancers in validation cohorts.
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Cancer Cell Diagnostics Launches CTC-Based Liquid Biopsy Test
Cancer Cell Diagnostics has launched the CellSight DNA test, a liquid biopsy that isolates intact circulating tumor cells for genomic profiling from a single blood draw, enabling analysis of over 500 genes and key biomarkers.
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Lucid Diagnostics Secures Commercial Coverage Policy for Its Esophageal DNA Test
Concert has issued a coverage policy deeming the EsoGuard Esophageal DNA Test medically necessary for eligible patients, with multiple client health plans now adopting the policy.
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Co-Diagnostics Submits FDA Notification for Upper Respiratory Multiplex Test
Co-Diagnostics has submitted a Dual 510(k) and CLIA waiver application to the FDA for its PCR-based flu and RSV test, aiming to enable point-of-care use on the Co-Dx PCR Pro instrument.
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Roche Expands Cyclospora Research Testing Portfolio Amid US Outbreak
Roche has launched two new research PCR assays for Cyclospora cayetanensis detection, expanding lab testing options amid a US outbreak and adding flexibility for gastrointestinal pathogen research.
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