Latest Medical Diagnostics News

Rhythm Biosciences has successfully validated its second-generation ColoSTAT® Beta assay, confirming its readiness for commercial application in colorectal cancer detection. The Beta kit offers improved precision and faster turnaround times compared to its predecessor.

Proteomics International has validated its PromarkerEndo blood test as a highly accurate, non-invasive diagnostic tool for endometriosis, with commercial launch planned in Australia for Q3 2025. The test promises to reduce the average seven-year diagnostic delay by providing a simple risk score applicable across all disease stages.

Atomo Diagnostics Limited has announced a capital raising initiative comprising a Share Purchase Plan (SPP) and a Placement, aiming to raise up to $1 million through the SPP and additional funds via a Placement, subject to shareholder approval at a June 23 meeting.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a fifth contractor, covering more than 70% of US Medicare payments and advancing its commercial reach.

Rhythm Biosciences’ subsidiary Genetype has landed a pivotal 12-month contract with the University of Melbourne to provide advanced breast cancer risk assessments, marking a significant step in personalised cancer screening.

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

Proteomics International Laboratories Ltd is raising up to $5.5 million through a $4 million placement and a $1 million Share Purchase Plan at $0.37 per share, offering shareholders a discounted entry and free attaching options.

Lumos Diagnostics reported a 21% quarter-on-quarter revenue increase in Q3 FY25, driven by strong product sales and expanded development agreements. The company also secured Medicare coverage in key US regions and advanced its pivotal FebriDx CLIA waiver study with FDA submission expected by year-end.

Rhythm Biosciences has fast-tracked the integration of the geneType™ business, restoring full commercial capabilities ahead of schedule and setting the stage for expanded market reach.

Rhythm Biosciences reported a strong December quarter, securing a $3.2 million R&D tax incentive and completing a strategic acquisition of Genetype assets, positioning the company for commercial expansion in cancer diagnostics.

Pacific Edge faces a significant Medicare reimbursement setback as Novitas finalizes a non-coverage decision for its Cxbladder tests, prompting the company to activate legal challenges and operational restructuring.