FDA Clears Rapid Molecular Test for Group A Strep
The point-of-care assay provides results in 15 minutes and received a waiver for use in decentralized settings.
Category: Molecular Diagnostics
Molecular Diagnostics
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Molecular Diagnostics
Latest
Liquid Biopsy Maps Tumor Microenvironment to Predict Immunotherapy Response
Mayo Clinic and Stanford Medicine researchers have developed a liquid biopsy that profiles tumor microenvironments to help predict immunotherapy response, according to a study published in Nature.
Molecular Diagnostics
Latest
Study: New Mapping Method Improves Detection of Leukemia Abnormalities
Research shows optical genome mapping identifies genomic changes in nearly 98% of T-cell acute lymphoblastic leukemia cases compared to 55% with traditional analysis.
Thermo Fisher Scientific Launches New DNA and RNA Analysis System
The integrated electrophoresis solution is designed to simplify routine verification by eliminating gel casting and buffer preparation.
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Labcorp Collaborates on Trial to Expand Colorectal Cancer Genetic Testing
The multicenter study will evaluate proactive outreach to at-risk relatives and the impact of multigene panel testing on patient care.
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Volta Labs Launches Automated Library Prep for Oxford Nanopore Sequencing Kits
The Callisto Sample Prep System application is optimized for the PromethION platform to support whole genome sequencing workflows.
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US Settles Genetic Testing Fraud Case Against Laboratory Owner
The settlement follows a criminal conviction and addresses more than $174 million in fraudulent Medicare claims involving multiple laboratories.
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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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ctDNA Blood Test May Help Guide Treatment Selection for Spreading Cancer
Research presented at ESTRO 2026 suggests circulating tumor DNA can identify which patients will benefit from combined radiation and drug therapy.
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Andes Virus Shifts Hantavirus Conversation for US Labs
Emerging Andes virus cases—capable of person-to-person transmission—are prompting US clinical labs to reassess hantavirus protocols and consider travel and epidemiologic exposures beyond rodent contact.
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Co-Diagnostics Develops Strategy for Ebola Bundibugyo Virus Assay
Co-Diagnostics has completed its assay development strategy for Bundibugyo virus, following the WHO’s emergency declaration and CDC’s updated traveler screening measures amid ongoing Ebola outbreaks in the DRC and Uganda.
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FDA Approves Companion Diagnostic to Identify NSCLC Patients Eligible for Tepmetko
The tissue-based test identifies patients with MET exon 14 skipping alterations eligible for treatment with tepotinib.
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FDA Approves Guardant Health’s New Blood-Based Cancer Test for Advanced Tumors
The FDA has approved Guardant360 Liquid CDx, a blood-based test that integrates genomic and epigenomic profiling for advanced cancer, offering a broader genomic footprint and faster results.
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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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Liquid Biopsy Predicts Immunotherapy Response in Breast Cancer, Study Shows
Researchers at Vanderbilt-Ingram Cancer Center report that RNA sequencing of blood samples can predict immunotherapy response in high-risk breast cancer patients.
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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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