Category: Molecular Diagnostics

Molecular Diagnostics

OGT Launches NGS Panel to Detect Residual Disease in Acute Myeloid Leukemia

The RNA-based panel detects leukemia-associated gene fusions at levels as low as 1% tumor cells, offering another approach to monitoring residual disease.

Molecular Diagnostics

Hologic and Inpeco Partner to Connect Panther Systems with FlexLab X Automation in Europe

The partnership will allow clinical laboratories to integrate multiple Panther Systems into automated workflows designed to increase testing capacity and improve sample tracking.

Molecular Diagnostics

Mayo Clinic Laboratories Invests in Pathology Asia to Expand Regional Genomic Testing

Mayo Clinic Laboratories and Pathology Asia Holdings have announced a strategic investment to expand regional access to molecular and genomic diagnostics in Southeast Asia, Australia, and New Zealand.

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.

Combining p-tau217 Blood Tests with APOE4 Genotyping Forecasts Alzheimer’s Symptom Onset, Study Finds

Sep 15, 2026 | Dementias & Alzheimer’s, Immunoassay, Molecular Diagnostics

A Columbia University study finds that combining plasma p-tau217 blood tests with APOE4 genotyping can predict Alzheimer’s symptom onset within three to four years in high-risk, asymptomatic individuals.

Fuse Diagnostics Secures £1M to Scale Point-of-Need Molecular Testing Platform

Sep 15, 2026 | Molecular Diagnostics

Fuse Diagnostics has raised £1 million to commercialize its instrument-free Flip molecular testing platform and expand manufacturing in Cambridge, UK, according to a company press release.