Category: Molecular Diagnostics

Molecular Diagnostics

FDA Grants Breakthrough Status to Blood Test to Distinguish Schizophrenia and Bipolar Disorder

The mRNA-based test aims to provide objective data to help clinicians distinguish between psychiatric conditions that often share symptoms.

Molecular Diagnostics

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.

Molecular Diagnostics

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.

Vaginal Swab Detects Molecular Signals for Endometrial Cancer

Apr 6, 2026 | Molecular Diagnostics, Womens Health

A peer-reviewed study suggests molecular signatures can be identified without invasive uterine sampling using whole-transcriptome sequencing and machine learning.

Molecular Test Detects Bile Duct Cancer at Twice the Rate of Standard Methods

Mar 31, 2026 | Cancer, Molecular Diagnostics

The BiliSeq molecular test detected bile duct cancer in 82% of cases—compared to 44% with standard pathology—according to a six-year, multi-institutional study.

FDA-Approved PD-L1 Companion Diagnostic Expanded to Esophageal and GEJ Carcinoma

Mar 27, 2026 | Molecular Diagnostics

The companion diagnostic can now help identify patients with esophageal or gastroesophageal junction carcinoma who may be eligible for pembrolizumab treatment.

CSF Liquid Biopsy Delivers 82% Clinical Impact Rate in CNS Lymphoma Cases

Mar 26, 2026 | Cancer, Lymphoma, Molecular Diagnostics

A retrospective study in Lymphatics reports that CSF liquid biopsy testing delivered clinical impact in 82% of CNS lymphoma cases, resolving diagnoses and informing treatment when standard methods were inconclusive.

Spatial Biology Workflow Gains New Panels and Amplification Kits

Mar 26, 2026 | Amplification Technologies

New additions to the COMET suite aim to improve flexibility and sensitivity in multiplex tissue analysis for research and preclinical development.

New IVD Assay Kits Bring Standardized NGS Workflows to Oncology Diagnostics

Mar 23, 2026 | Molecular 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

Mar 19, 2026 | Breast, Cancer, Molecular Diagnostics

Researchers found that circulating tumor DNA testing could identify which older patients with estrogen receptor–positive breast cancer are less likely to respond to hormone therapy alone.

University of Colorado Licenses RNA Synthesis Technology to Cirena for Long-Construct Production

Mar 18, 2026 | Molecular Diagnostics

Cirena has licensed a University of Colorado Boulder RNA synthesis technology, enabling scalable production of high-purity, 100–400 nt RNA constructs for CRISPR, functional genomics, and RNA therapeutics research.

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

Mar 12, 2026 | Molecular Diagnostics

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.

FDA Grants Breakthrough Device Designation to MeMed’s Capillary Blood Infection Test

Mar 12, 2026 | Infectious Diseases, Lab Management, Molecular Diagnostics

The FDA has granted Breakthrough Device Designation to MeMed BV Flex, an AI-powered capillary blood test designed to distinguish bacterial from viral infections in 15 minutes using host-response biomarkers.

MyOme Adds Methylation Analysis to Whole-Genome Platform and Partners with Natera on New Test Portfolio

Mar 12, 2026 | Molecular Diagnostics

The Menlo Park-based company is integrating epigenetic signatures into its rare disease diagnostics offering, with the new capability set to roll out automatically in early Q2 2026.

NIH Awards $2.5 Million to Advance Eye-Based Detection of ALS Biomarker TDP-43

Mar 11, 2026 | Molecular Diagnostics

The Phase 2 grant supports AI-driven analysis of retinal tissue to identify disease-specific patterns linked to ALS, FTD, and LATE.

Alithea Genomics Raises $8.9 Million to Scale RNA Sequencing for Drug Discovery

Mar 5, 2026 | Molecular Diagnostics

Swiss company’s 1536-well technology aims to make transcriptomics cost-effective for primary drug screening and toxicology applications.

AI Liquid Biopsy Test Detects Early Liver Fibrosis and Cirrhosis

Mar 5, 2026 | Molecular Diagnostics

Johns Hopkins researchers have developed an AI-driven liquid biopsy that uses cell-free DNA fragmentation patterns to detect early liver fibrosis and cirrhosis, according to a study in Science Translational Medicine.