Latest Biomarkers News

Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.

Cleo Diagnostics has completed blood sample collection for its pivotal U.S. clinical trial, advancing its Pre-Surgical Ovarian Cancer Test closer to FDA submission.

BlinkLab has enrolled its first participant in the pivotal FDA 510(k) validation study for its autism diagnostic aid, BlinkLab Dx1, aiming for regulatory submission by the end of 2026.

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

Rhythm Biosciences has completed the first commercial sale of its ColoSTAT® blood test for colorectal cancer, confirming the full clinical and logistical process is operational and ready for expansion.

Entropy Neurodynamics reports a 14.8% reduction in half-year losses while progressing a pioneering clinical trial for Binge Eating Disorder using its proprietary psychedelic drug TRP-8803. The company also secured $6.1 million in new funding and strategic collaborations to enhance its neuropsychiatry platform.

Paradigm Biopharmaceuticals reports a sharp rise in half-year losses as it intensifies investment in its pivotal Phase 3 trial for knee osteoarthritis, setting sights on a critical interim analysis in mid-2026. The company also expands its osteoarthritis pipeline and maintains strong funding amid a strengthening biotech sector.

Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.

A recent expert panel convened by Novitas has strongly endorsed Pacific Edge’s urine-based Cxbladder tests for hematuria evaluation, recommending Medicare coverage based on robust clinical evidence and patient care benefits.

Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.

INOVIQ Limited reported a $3.96 million net loss for H1 2026, driven by increased R&D spend, while securing $10.2 million to accelerate its exosome-based cancer diagnostics and therapeutics pipeline.

Rhythm Biosciences has inked a non-exclusive distribution agreement with 4Cyte Pathology to integrate its ColoSTAT® colorectal cancer blood test into a vast pathology network across eastern Australia, aiming to boost adoption and accessibility.