Category: Molecular Diagnostics

Molecular Diagnostics

Watchmaker Genomics Introduces PCR-Free Whole Genome Sequencing Workflow

The workflow eliminates separate qPCR quantification and manual normalization steps, preparing sequencing-ready libraries in approximately 2.5 hours.

Molecular Diagnostics

FDA Clears Point-of-Care Vaginitis PCR Panel with CLIA Waiver

The 20-minute multiplex test delivers eight results covering bacterial vaginosis, Candida species, and trichomoniasis from clinician- or self-collected swabs.

Molecular Diagnostics

Nabsys Launches Tool to Analyze Genetic Repeat Expansions Linked to Inherited Disorders

New software allows researchers to examine repeat expansions associated with up to 23 disease-related genetic regions in a single run.

Federal Directive Spurs R&D Focus on Rapid Diagnostics for Vector-Borne Diseases

Oct 8, 2026 | Emerging & Zoonotic Diseases, Molecular Diagnostics

A new federal directive tasks HHS with launching rapid diagnostic R&D for vector-borne diseases, emphasizing decentralized molecular testing as part of a broader strategy to improve local pathogen surveillance.

10x Genomics, Fred Hutch Launch Cancer Diagnostics Research Collaboration

Oct 7, 2026 | Cancer, Leukemia, Molecular Diagnostics

10x Genomics and Fred Hutchinson Cancer Center have launched a multi-project collaboration to study single cell and spatial profiling for cancer diagnostics, including biomarkers in bladder cancer and residual disease detection in AML.

Roche Adds Molecular Testing Capacity in Democratic Republic of Congo Amid Ebola Outbreak

Oct 7, 2026 | Emerging & Zoonotic Diseases, Molecular Diagnostics

Roche Diagnostics has supplied two molecular testing systems and is training laboratory staff in the Democratic Republic of Congo to expand PCR testing capacity for Bundibugyo virus amid rising Ebola testing demand.

Cerenome Launches Two CSF Molecular Profiling Tests for CNS Cancers

Oct 7, 2026 | Cancer, Molecular Diagnostics

Cerenome has launched two CSF-based molecular profiling tests for CNS cancers, offering DNA and RNA sequencing panels to evaluate primary, metastatic, and hematologic malignancies in the central nervous system.

Baylor Genetics Named Lead Sequencing Partner for Florida Newborn Screening Pilot

Oct 7, 2026 | Company News, Molecular Diagnostics

Baylor Genetics has been named lead sequencing provider for Florida’s five-year Sunshine Genetics Pilot, which will use whole-genome sequencing to screen newborns for nearly 900 genetic conditions statewide.

Study Validates High-Throughput Proteomics for Measuring Endothelin-1

Oct 6, 2026 | Cardiovascular, Molecular Diagnostics

A peer-reviewed study found that Olink proximity extension assay technology correlates with ELISA for measuring endothelin-1 in coronary artery plasma, supporting its use for high-throughput proteomics in clinical research.

Pillar Biosciences Launches 80-Gene NGS Panel for Myeloid Malignancies

Oct 6, 2026 | Cancer, Molecular Diagnostics

Pillar Biosciences has introduced the oncoReveal Myeloid v2 Panel, expanding its NGS assay from 58 to 80 genes and enhancing FLT3-ITD detection while maintaining existing laboratory workflows.

Population Proteomics Study Identifies Over 2,500 New Genetic-Protein Links

Oct 5, 2026 | Mass Spectrometry, Molecular Diagnostics

Researchers from the PRECISE-SG100K study have identified over 2,500 new genetic-protein associations by analyzing data from 10,000 participants, advancing biomarker discovery in large-scale, multi-ethnic cohorts.

Renew Biotechnologies, Mayo Clinic Partner to Evaluate cfDNA Biomarker in Multiple Sclerosis

Oct 1, 2026 | Allergy & Autoimmune, Molecular Diagnostics

Renew Biotechnologies and Mayo Clinic have partnered to evaluate NeuroLens, a cfDNA-based test, for monitoring central nervous system injury and disease progression in multiple sclerosis and related neuroimmunologic conditions.

Roche Launches Newborn Screening Test for Three Severe Genetic Conditions

Sep 30, 2026 | Amplification Technologies

Roche subsidiary TIB MOLBIOL has launched a CE-marked newborn screening kit that simultaneously tests for spinal muscular atrophy, severe combined immunodeficiency, and sickle cell disease in laboratories across Europe.

FDA Clears Qiagen Gram-Negative Bloodstream Infection Panel

Sep 28, 2026 | Molecular Diagnostics

The FDA has cleared Qiagen’s QIAstat-Dx BCID GN Plus AMR Panel, enabling U.S. labs to detect 13 gram-negative bacterial pathogens and 18 resistance markers in about one hour on the QIAstat-Dx system.

Coffee Mug Powers Portable Test for Seven Mosquito-Borne Viruses

Sep 25, 2026 | Amplification Technologies, Infectious Diseases, Molecular Diagnostics

University of Florida researchers have developed a portable diagnostic device that detects and differentiates seven mosquito-borne viruses in under an hour, offering rapid results without the need for traditional lab equipment.

DNA Test Diagnoses Inherited Muscle Diseases Missed by Standard Testing

Sep 25, 2026 | Allergy & Autoimmune, Molecular Diagnostics

Garvan Institute researchers have developed a long-read nanopore DNA test that screens over 300 genes, diagnosing inherited muscle diseases in cases missed by standard testing.

FDA Advisory Panel Backs Approval of GRAIL’s Galleri Multi-Cancer Early Detection Test

Sep 25, 2026 | Cancer, Compliance, Molecular Diagnostics

An FDA advisory panel voted 7-2 that the benefits of GRAIL’s Galleri multi-cancer early detection blood test outweigh its risks for adults 50 and older, supporting its premarket approval application.

OGT Expands NGS Indexing Capacity to 384 Samples Per Run

Sep 18, 2026 | Sequencing Systems

OGT has expanded its SureSeq Universal NGS Unique Dual Index portfolio, enabling up to 384 uniquely indexed samples per run on Illumina platforms, quadrupling previous capacity and supporting higher-throughput workflows, according to the company.