Sysmex Europe Launches Automated Blood Testing Platform for Alzheimer’s Disease
The system uses routine blood draws to provide results in 17 minutes, offering an alternative to invasive diagnostic methods.
Category: Molecular Diagnostics
Molecular Diagnostics
Latest
Molecular Diagnostics
Latest
Study Shows Blood Test Predicts Breast Cancer Recurrence Years Before Clinical Symptoms
Monitoring circulating tumor DNA dynamics outperformed standard markers for predicting survival and relapse in early-stage patients.
Molecular Diagnostics
Latest
Large Study Shows Multi-Cancer Early Detection Test Increases Cancer Detection
Results from the PATHFINDER 2 trial show the Galleri test identifies 6.5 times more cancers when used with standard screenings.
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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Researchers Develop Test to Detect Biomarkers for Specific Type of Dementia
Researchers at Mass General Brigham have developed a digital seed amplification assay that detects TDP-43 protein seeds in cerebrospinal fluid, enabling identification of FTLD-TDP, a specific frontotemporal lobar degeneration subtype.
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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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BillionToOne Launches Non-Invasive Prenatal Confirmation Test Using Fetal Cells
BillionToOne has launched Unity Confirm, a non-invasive prenatal test that isolates fetal cells from maternal blood to confirm high-risk screening results, addressing the gap between NIPT and invasive diagnostics.
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FDA Clears New Genomic Test for Solid Tumors
The FDA has cleared Datar Cancer Genetics’ CellDx-Tissue, a genomic profiling assay that analyzes 517 cancer-associated genes from solid tumor tissue to support clinical decision-making, according to the company.
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Caris Life Sciences Seeks New York State Authorization for Blood-Based Cancer Test
Caris Life Sciences has applied to the New York State Department of Health for authorization of Caris Assure, a blood-based molecular profiling test for cancer using whole exome and transcriptome sequencing of 22,000 genes.
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