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.
Category: Molecular Diagnostics
Molecular Diagnostics
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Molecular Diagnostics
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GenomOncology and PacBio Launch Integrated Oncology Sequencing Workflow
GenomOncology and PacBio have introduced an integrated workflow for somatic whole-genome sequencing in oncology, combining PacBio’s HiFi WGS analysis with GenomOncology’s reporting platform for standardized clinical lab reporting.
Molecular Diagnostics
Latest
Labcorp Launches Consumer Genetic Health Panel for Hereditary Risk Assessment
Labcorp has announced the upcoming launch of the Marker by Labcorp Genetic Health Panel, which will analyze 163 genes linked to over 100 medically actionable conditions, with results supported by licensed genetic counselors.
Myriad Genetics Launches New Four-in-One Prenatal Genetic Screen
Myriad Genetics has launched the FirstGene Multiple Prenatal Screen, a test that combines four prenatal genetic screens from a single blood draw as early as eight weeks gestation, according to the company.
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Global Study to Evaluate Syndromic PCR Testing for Infectious Diseases
Seegene has launched the Global Million Clinical Study to collect real-world data on the clinical utility of syndromic PCR testing for infectious diseases, aiming to inform future global diagnostic standards.
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CareDx Completes Acquisition of Cancer Diagnostic Company
The deal adds a blood-based test for viral-mediated cancers to the company’s portfolio of transplant and cell therapy services.
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Epigenetic Tests Reduce Reliance on Self-Reported Smoking and Alcohol Use in Clinical Trials
Behavioral Diagnostics and Versiti Clinical Trial Solutions have partnered to provide epigenetic assays for objective smoking and alcohol exposure screening in clinical trials, aiming to improve participant risk assessment and data reliability.
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FDA-Cleared Molecular Test Targets Growing US Cyclospora Outbreak
QIAGEN’s FDA-cleared QIAstat-Dx panel detects Cyclospora cayetanensis, addressing a surge of over 1,600 confirmed US cases since May 2026.
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Researchers Develop Electronic Genome Mapping Assay for FSHD Diagnosis
Nabsys and Leiden University Medical Center are collaborating to evaluate an electronic genome mapping assay for improved detection of FSHD-associated repeat contractions, aiming to address current diagnostic limitations.
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Roche Introduces Automated Test for Hepatitis D Virus
The fully automated, high-throughput assay for Hepatitis D virus RNA is available on cobas 5800/6800/8800 systems in CE mark-accepting countries.
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Bio-Rad Releases New Quality Control Kits for Cell and Gene Therapy
Bio-Rad has launched Vericheck ddPCR kits for quality control in cell and gene therapy manufacturing, offering validated workflows for mycoplasma detection, capsid analysis, and residual DNA quantification.
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Caris Life Sciences Launches New Blood Test for Early Cancer Detection
The test utilizes genomic sequencing and AI to identify biological signals associated with early-stage disease.
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Eurobio Scientific Finalizes Acquisition of CareDx Lab Product Division
The transaction includes subsidiaries in the United States, Sweden, and Australia to expand transplantation diagnostic offerings.
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Single-Cell Sequencing May Identify New Exercise Biomarkers
Research suggests new sequencing technologies can help labs move from tissue-level averages to cell-specific testing for precision exercise medicine.
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HerAnova Presents Validation Data for Endometriosis Blood Test
HerAnova Lifesciences presented validation data for HerResolve, a blood-based endometriosis test, showing 94.4% accuracy and detection of cases missed by imaging.
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Roche Launches New DNA Sequencing Platform AXELIOS 1
Roche has launched AXELIOS 1, a single-molecule sequencing platform that uses sequencing by expansion technology to deliver same-day whole-genome results.
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Countable Labs and Promega Partner for Sample Preparation and Rare Variant Detection
The agreement combines extraction and PCR technologies to create an end-to-end workflow for DNA and RNA analysis.
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Watchmaker Genomics Launches Tools to Streamline Sequencing Workflows
The new technologies address library normalization and amplification accuracy for high-throughput and oncology sequencing.
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