FDA Grants Breakthrough Designation to Liquid Biopsy for Invasive Mold Infections
The panel detects fungal DNA in plasma to help identify specific pathogens in immunocompromised patients.
Category: Molecular Diagnostics
Molecular Diagnostics
Latest
Molecular Diagnostics
Latest
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.
Molecular Diagnostics
Latest
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.
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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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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Liquid Biopsy of Tumor Microenvironment Predicts Cancer Therapy Response
LiquidCell Dx has published research in Nature on LiquidTME, a blood-based assay that profiles the tumor microenvironment and predicts immunotherapy response, potentially offering a noninvasive alternative to tissue biopsy.
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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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How Labs Are Driving the Andes Hantavirus Outbreak Response
Laboratories are leveraging established diagnostic and surveillance tools to track the Andes hantavirus outbreak linked to a cruise ship, with experts noting no evidence of widespread community transmission or efficient airborne spread.
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Foundation Medicine Expands Bristol Myers Squibb Deal to Develop MTAP Biomarker Test
Foundation Medicine and Bristol Myers Squibb have expanded their partnership to develop an NGS-based companion diagnostic for identifying homozygous MTAP deletions, supporting targeted therapy development in precision oncology.
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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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GRAIL to Present New Data on Multi-Cancer Early Detection Test
Presentations will feature results from the NHS-Galleri and PATHFINDER 2 studies involving more than 174,000 participants.
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New Data Supports Multi-Omic Blood Test for Early Ovarian Cancer Detection
AOA Dx presented data at AACR 2026 supporting its AKRIVIS GD Test System, a multi-omic, blood-based assay for early ovarian cancer detection in symptomatic women, reporting an AUC of 0.92 in clinical controls.
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A Urine Test That Could Help Predict Bladder Cancer Recurrence
Researchers have developed a urine-based liquid biopsy test that filters age-related mutations, potentially enabling more accurate prediction of bladder cancer recurrence and guiding immunotherapy decisions.
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