Latest Medical Diagnostics News

Nexsen has secured ISO 13485 certification covering the design, development and manufacture of its StrepSure Group B Streptococcus diagnostic. The milestone strengthens the product’s regulatory and manufacturing platform, but does not yet amount to FDA or TGA approval.

An independent, Rhythm-funded economic model estimates its ColoSTAT blood test could avoid 29,427 public-hospital colonoscopies a year and deliver $72.4 million in net annual hospital savings. The figures strengthen Rhythm’s planned case for Medicare reimbursement, but remain modelled estimates rather than evidence from real-world use.

Sonic Healthcare delivered a strong FY2026, with underlying net profit up 17% to A$621 million and dividends rising to A$1.08 per share. The next test is whether US efficiencies, LADR synergies and organic growth can offset Swiss fee cuts, a delayed UK contract ramp-up and heavier investment demands.

Microba shareholders would own about 67% of an enlarged Genetic Signatures under a proposed all-scrip merger valued at approximately A$51 million. The deal combines roughly A$29.6 million of FY2026 revenue and identifies up to A$3 million in potential annual cost synergies, but remains subject to a long list of approvals.

Rhythm Biosciences has completed the first phase of transferring its ColoSTAT blood test to an independent NHS laboratory in England. The milestone supports its international laboratory-partnership strategy, but clinical validation and NHS adoption remain ahead.

Cleo Diagnostics has received its first commercial batch of ovarian cancer test kits from Bio-Techne, marking the start of analytical validation critical for its FDA submission planned in early 2027.

Rhythm Biosciences marked its transition to commercialisation with first sales of ColoSTAT® and geneType™ tests, despite a 55% increase in loss to $5.93 million. The company expanded market access and secured manufacturing agreements, while NHS England began evaluating ColoSTAT® for bowel cancer screening.

Integral Diagnostics (ASX: IDX) delivered a robust FY26 with 26% revenue growth to $788.6 million, a 677% surge in profit after tax to $22 million, and a 50% hike in its final dividend to 6 cents per share.

Pacific Edge’s draft Medicare Local Coverage Determination for its Cxbladder bladder cancer tests marks a pivotal step toward unlocking a $10.2 billion global market. Despite FY26 setbacks, the company is poised for growth with improved reimbursement prospects and strategic cost management.

Archer Materials has pinpointed a capillary blood collection method that matches venous samples in haemolysis levels, advancing its potassium Biosensor development towards integrated clinical testing.

Proteomics International has achieved a key patent acceptance in Australia for its PromarkerEndo blood test, reinforcing its intellectual property portfolio and commercialisation strategy in a major healthcare market.

BCAL Diagnostics has strengthened its leadership, advanced breast cancer detection tests, and secured key funding and strategic investments to underpin its FY2027 growth plans.