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.
Tag: molecular diagnostics
All
Latest
All
Latest
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.
All
Latest
Portable Tuberculosis Test Matches Laboratory Accuracy in Minutes, Study Finds
A study finds the battery-powered MiniDock MTB delivers lab-accurate tuberculosis results from tongue swabs in under 30 minutes.
Astrin Biosciences Earns CAP Accreditation for Breast Cancer Blood Test
Astrin Biosciences has earned CAP accreditation for its St. Paul, Minn, lab, supporting the clinical rollout of Certitude Breast, a proteomics-based blood test for early breast cancer detection.
Read More
AidaBREAST Multi-Omic Assay Demonstrates Spatial Proteomics for Clinical Oncology
The assay predicts both locoregional recurrence risk and radiation therapy benefit in early-stage invasive breast cancer.
Read More
Ultima Genomics Presents New Data for Cancer Detection Technology at AACR 2026
Ultima Genomics presented data at AACR 2026 showing its ppmSeq technology detected circulating tumor DNA at low single-digit parts-per-million in a TRACERx pilot of 50 plasma samples.
Read More
FDA Grants Breakthrough Status to Liquid Biopsy for Liver Cancer Monitoring
TCM Biotech has received FDA Breakthrough Device Designation for CatCHimera, a liquid biopsy platform for monitoring minimal residual disease in hepatocellular carcinoma using HBV–host genome integration biomarkers.
Read More
Labcorp Launches Companion Diagnostic for Ovarian Cancer Treatment
Labcorp has launched nationwide testing with Agilent’s FDA-approved PD-L1 IHC 22C3 pharmDx, enabling identification of patients with platinum-resistant ovarian cancer eligible for pembrolizumab immunotherapy.
Read More
Optical Genome Mapping Catches Missed Genetic Variants in Nearly 20% of Acute Leukemia Cases
Optical genome mapping detected clinically significant genetic variants missed by standard tests in nearly 20% of acute leukemia cases, according to a 200-patient study.
Read More
Seegene Introduces New Data Platform and Automated PCR System
Seegene unveiled its STAgora real-time data analytics platform and an updated CURECA automated PCR system at ESCMID Global 2026, aiming to enhance infectious disease monitoring through integrated laboratory workflows and aggregated test data.
Read More
QuidelOrtho Completes Acquisition of LEX Diagnostics and Molecular Testing Platform
The $100 million deal brings an ultra-fast system for respiratory viruses to QuidelOrtho’s point-of-care portfolio.
Read More
Biocartis Earns European Certification for Colorectal Cancer Companion Diagnostic Test
The Idylla CDx MSI Test detects microsatellite instability in colorectal cancer tissue in under three hours, supporting therapy selection for eligible patients.
Read More
CellCarta Secures Exclusive Global Rights to Deploy Aspyre Lung Assay in Lung Cancer Clinical Trials
CellCarta has secured exclusive global rights to deploy Biofidelity’s Aspyre Lung assay in lung cancer clinical trials, streamlining genomic testing for trial sponsors and reducing reliance on multiple vendors.
Read More
Seed Funding to Advance Biopsy Catchment Technology and Liquid Specimen Biorepository
A $4 million financing round will support development of a liquid specimen biorepository and expand biopsy catchment pilot programs at medical institutions across the US.
Read More
Clinical Trial to Evaluate Finger-Prick Blood Test for Alzheimer’s Diagnosis
The study will analyze three key proteins to determine if blood-based biomarkers can provide an earlier and more accessible diagnostic method.
Read More
Automated Cytomegalovirus PCR Assay Receives IVDR Certification for Transplant Care
The test allows for simultaneous detection of multiple viruses on a sample-to-answer platform designed for immunocompromised patients.
Read More
Blood-Based Biomarker Identifies Cancer Risk in Lynch Syndrome Patients
Researchers at MD Anderson have identified a blood-based biomarker using T cell receptor sequencing that may help assess cancer risk in asymptomatic Lynch syndrome carriers, according to a study in Nature Communications.
Read More
FDA Clears At-Home Cervical Cancer Screening Tool
The clearance of the Onclarity HPV Self-Collection Kit and approval of the BD Onclarity HPV Assay aim to reduce barriers for unscreened populations.
Read More