Molecular Diagnostics

FDA Issues Draft Guidance for Gene Therapy Genome Editing Safety

The recommendations focus on using next-generation sequencing to evaluate off-target editing risks and chromosomal integrity.

Molecular Diagnostics

Baylor Genetics Adds Optical Genome Mapping and Long-Read Sequencing to Whole Genome Sequencing Test

Baylor Genetics has added optical genome mapping and long-read sequencing to its whole genome sequencing test, expanding STR analysis, enabling FMR1 methylation detection, and improving structural variant interpretation.

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.

Thermo Fisher Introduces Sequential Protein/DNA/RNA Extraction Kit

Feb 19, 2026 | Molecular Diagnostics

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.

Singular Genomics Launches High-Throughput Spatial Analysis Platform in US

Feb 18, 2026 | Molecular Diagnostics

The G4X system can analyze 128 samples per run with 500-plex RNA and 18-plex protein capabilities, targeting translational research and clinical applications.

Cirena Launches Long RNA Synthesis Platform for CRISPR Applications

Feb 13, 2026 | Amplification Technologies

The technology is designed to deliver high-purity long RNA to support CRISPR and functional genomics workflows.

BillionToOne Launches Two Liquid Biopsy Add-On Tests for Cancer Therapy Selection

Feb 10, 2026 | Molecular Diagnostic Analyzers

BillionToOne has launched Northstar PGx and Northstar Select CH, two liquid biopsy add-on tests for advanced solid tumor therapy selection, enabling pharmacogenomic insights and clonal hematopoiesis detection from a single blood draw.

New Test Strip Detects Cancer Biomarkers at Ultra-Low Concentrations

Feb 6, 2026 | Cancer, Molecular Diagnostic Analyzers, Molecular Diagnostics

Researchers at La Trobe University have developed a single-use test strip that detects cancer-related microRNAs in blood plasma at concentrations up to 1,000 times lower than current methods.

Ambry Genetics Reaches 1 Million RNA-Enhanced Genetic Tests

Feb 2, 2026 | Molecular Diagnostics

Ambry Genetics has completed its one millionth DNA/RNA genetic test, highlighting increased adoption of RNA-enhanced diagnostics for hereditary cancer and rare diseases, according to the company.

Bipartisan Bill Would Expand Medicaid Coverage for Pediatric Genomic Sequencing

Jan 20, 2026 | Molecular Diagnostics

A bipartisan House bill would require Medicaid to cover whole genome and exome sequencing for children with suspected rare diseases, aiming to improve diagnostic access and reduce costs, according to lawmakers and recent pilot programs.

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.