Latest Medical Diagnostics News

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.

Rhythm Biosciences bolstered its financial position with a $5.2 million option underwriting while accelerating commercial adoption of its ColoSTAT® colorectal cancer test and advancing geneType™ partnerships internationally in Q4 FY26.

Cleo Diagnostics has entered the critical Analytical Validation phase for its ovarian cancer blood test, progressing toward an FDA 510(k) submission targeted for the first half of 2027. The company also secured a U.S. reimbursement pathway to support early market entry post-clearance, backed by a cash balance of A$6.2 million.

Lumos Diagnostics reported a 6% revenue increase to US$13.2 million for FY26, driven by an 875% surge in FebriDx® sales following a pivotal CLIA waiver. The company expanded U.S. adoption to 170+ healthcare sites and secured milestone payments exceeding US$6 million.