Invivoscribe has begun shipping its PrepQuant System in North America, an automated platform designed to streamline nucleic acid extraction, concentration, and quantification for MRD testing workflows.
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.
Clinical labs are adopting broader cancer diagnostics—including whole-genome sequencing and multi-omic testing—to deliver more comprehensive molecular insights and improve disease monitoring.
RNA-based testing improves detection of MET exon 14 skipping in NSCLC, identifying mutations missed by DNA-only assays, according to new research. Findings may impact eligibility for targeted therapies.
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Seegene has introduced a syndromic PCR-based test for simultaneous detection of STIs and HPV. Company data show co-detection in 71% of positive cases, supporting potential clinical utility for comprehensive reproductive infection screening.
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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.
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The company is showcasing newly cleared tests and platforms for multiple myeloma, lung cancer, connective tissue disease, and other laboratory applications.
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The funding will support regulatory certification and the commercial launch of rapid tests for Lyme disease and sexually transmitted infections.
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As Cyclospora infections surge in the US, laboratories face increased pressure to quickly differentiate cases, with the CDC reporting 1,947 confirmed infections and 98 hospitalizations across nine states as of July 24.
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The program connects researchers with certified laboratories offering single-molecule PCR testing, technical support, and bioinformatics expertise.
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The test uses intact circulating tumor cells instead of cell-free DNA fragments to analyze more than 500 genes and identify tumor markers.
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Cepheid will debut its third-generation GeneXpert molecular testing system at ADLM 2024, featuring a touchscreen interface, updated software, and continued support for FDA-cleared tests and existing laboratory workflows.
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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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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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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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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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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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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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