The Next Era of Diagnostic Stewardship
As molecular diagnostics expand what laboratories can detect, laboratories are placing greater emphasis on matching the breadth of testing to the patient and how the results will be used.
Category: Molecular Diagnostics
Molecular Diagnostics
Latest
Molecular Diagnostics
Latest
Roche Launches Newborn Screening Test for Three Severe Genetic Conditions
Roche subsidiary TIB MOLBIOL has launched a CE-marked newborn screening kit that simultaneously tests for spinal muscular atrophy, severe combined immunodeficiency, and sickle cell disease in laboratories across Europe.
Molecular Diagnostics
Latest
Fuse Diagnostics Secures £1M to Scale Point-of-Need Molecular Testing Platform
Fuse Diagnostics has raised £1 million to commercialize its instrument-free Flip molecular testing platform and expand manufacturing in Cambridge, UK, according to a company press release.
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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SOPHiA GENETICS and AstraZeneca Collaborate to Develop Oncology Companion Diagnostics
SOPHiA GENETICS and AstraZeneca have signed a multi-year agreement to develop and deploy decentralized companion diagnostics for solid tumors and blood cancers, aiming to expand local lab access to precision oncology testing.
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