Molecular Diagnostics

New IVD Assay Kits Bring Standardized NGS Workflows to Oncology Diagnostics

Powered by anchored multiplex PCR chemistry, the in vitro diagnostic offerings target fusion and variant detection for molecular pathology laboratories.

Blood Test May Help Guide Breast Cancer Treatment Decisions in Women 70 and Older
University of Colorado Licenses RNA Synthesis Technology to Cirena for Long-Construct Production
Baylor Genetics Adds Optical Genome Mapping and Long-Read Sequencing to Whole Genome Sequencing Test
FDA Grants Breakthrough Device Designation to MeMed’s Capillary Blood Infection Test
MyOme Adds Methylation Analysis to Whole-Genome Platform and Partners with Natera on New Test Portfolio
NIH Awards $2.5 Million to Advance Eye-Based Detection of ALS Biomarker TDP-43
Alithea Genomics Raises $8.9 Million to Scale RNA Sequencing for Drug Discovery
AI Liquid Biopsy Test Detects Early Liver Fibrosis and Cirrhosis
Can Comprehensive Genomic Profiling Be Done in 24 Hours?

Molecular Diagnostics

Illumina Announces NovaSeq X Performance Upgrades Including Q70 Quality Scores

Illumina has announced an 18-month roadmap for NovaSeq X, featuring a 40% output increase to 35 billion reads, faster turnaround times, new flow cell options, and the introduction of Q70 quality scores.

Molecular Diagnostics

Thermo Fisher Introduces Sequential Protein/DNA/RNA Extraction Kit

Thermo Fisher Scientific has launched a kit enabling sequential extraction of protein, DNA, and RNA from a single sample, supporting multi-omics cancer research and downstream mass spectrometry and sequencing applications.

New Standards Issued for Liquid Biopsy Cancer Recurrence Tests

Jan 16, 2026 | Molecular Diagnostics

The BLOODPAC Consortium has released new analytical validation standards for liquid biopsy MRD tests, offering industry-wide protocols for tumor-informed ctDNA assay development, as detailed in JCO Precision Oncology.

New Method Shows Superior Sensitivity in Liquid Biopsy Testing

Jan 16, 2026 | Molecular Diagnostics

Bridge Capture, a targeted NGS method, showed higher sensitivity for detecting rare ctDNA variants than two leading liquid biopsy assays, according to research in The Journal of Molecular Diagnostics.

Whole-Genome Sequencing Algorithm Shows Promise for PARP Inhibitor Selection

Jan 15, 2026 | Molecular Diagnostics

Weill Cornell Medicine researchers report a whole-genome sequencing algorithm may identify more patients for PARP inhibitor cancer therapies than current commercial tests, according to a study in Communications Medicine.

Thermo Fisher Launches HepatoExpress Kit for Liver Cell Gene Expression Analysis

Jan 14, 2026 | Amplification Technologies

New kit cuts sample-to-result time to 75 minutes while maintaining sensitivity for drug metabolism studies.

New Stool Test Targets Specific Enzyme to Improve IBD Diagnosis

Jan 13, 2026 | Molecular Diagnostics

Researchers have developed a tool that measures gut-specific inflammation, potentially improving IBD diagnosis and monitoring.

New Hepatitis C Point-of-Care Test Shows Promise Despite High Costs

Jan 5, 2026 | Molecular Diagnostics

University of Washington researchers find rapid test could improve treatment rates but may face implementation barriers due to reimbursement challenges.

Helio Genomics Partners with LiverRight to Expand Access to Liver Cancer Detection

Dec 30, 2025 | Molecular Diagnostics

The collaboration integrates AI-driven blood testing with a nationwide hepatology specialist network to reduce diagnostic delays.

BD Expands BD Max System Menu with IVDR-Certified Viasure Assays

Dec 29, 2025 | Molecular Diagnostic Analyzers

Partnership with Certest Biotec adds respiratory and STI molecular diagnostic panels for European laboratories.

Yenos Analytical Launches Multi-Cancer Early Detection Urine Test

Dec 19, 2025 | Cancer, Company News, Molecular Diagnostics

The direct-to-consumer laboratory-developed test detects six cancer types with 97% sensitivity and specificity using microRNA biomarkers, according to the company.

Roche Launches Updated cobas 6800/8800 Systems with Enhanced Testing Capabilities

Dec 17, 2025 | Molecular Diagnostic Analyzers

The version 2.0 systems feature increased throughput, expanded assay flexibility, and the ability to run up to six unique assays per run.

DNAe Launches Early Access Program for NGS Diagnostic Platform

Dec 12, 2025 | Molecular Diagnostics

Hospital teams can trial the company’s BSI/AMR test and preview the LiDia-SEQ system ahead of commercial launch.

Foundation Medicine Reaches 100 Approved Companion Diagnostic Indications

Dec 8, 2025 | Molecular Diagnostics

The precision medicine company now has 57 approvals in the US and 43 in Japan for its FoundationOne CDx and FoundationOne Liquid CDx tests.

New Partnership Aims to Expand Access to AI-Driven Cancer Genomic Testing

Dec 5, 2025 | Analytical Software Systems, Cancer, Molecular Diagnostics

The collaboration combines AI-based analysis tools with a next-generation sequencing system to support labs performing tumor and liquid biopsy testing.