Colombia Approves CRISPR-Based Blood Test for Tuberculosis
IntelliGenome receives regulatory clearance and partners with Velez Lab for distribution of its molecular diagnostic assay.
Tag: molecular diagnostics
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Quest Gains New York Approval for Haystack MRD Cancer Monitoring Test
The approval allows Quest Diagnostics to offer its minimal residual disease test for patients in all 50 states.
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MGI Tech Unveils New Laboratory Automation and Proteomics Solutions
The company introduced systems for single-cell proteomics, clinical sample processing, and spatial proteomics.
DELFI Diagnostics Receives New York State Approval for Lung Cancer Blood Test
The authorization from the New York State Department of Health makes the screening test available in all 50 states.
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Biotia Launches Antimicrobial Resistance Test for Complicated UTIs
The technology provides rapid resistance profiling for recurrent or complicated infections and is approved for use in all 50 US states.
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ClearNote Health Raises $52 Million for Early Cancer Detection Tests
The funding will support commercial expansion of the company’s blood-based diagnostic tests and the appointment of a new president and chief operating officer.
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TGen Launches 72-Hour Whole Genome Sequencing Test for Multiple Myeloma
TGen has launched JAYseq, a clinical whole genome sequencing test for multiple myeloma that delivers results in 72 hours, enabling rapid identification of genetic changes and immunotherapy targets, according to the institute.
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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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