Latest Medical Diagnostics News

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.

Atomo Diagnostics reported a 40% increase in FY26 revenue to $5.3 million, driven by a surge in HIV self-test sales and new OEM customer orders. The company is advancing its syphilis and liver test developments while enhancing manufacturing capacity.

Proteomics International has locked in a three-year exclusive distribution deal with Healius, leveraging its extensive pathology network to roll out its Promarker® diagnostic tests nationally from FY27.

Pacific Edge edges closer to Medicare reimbursement for its bladder cancer tests while its Asia Pacific operations show rising test volumes and improved margins, signaling a path toward profitability.

Cleo Diagnostics (ASX:COV) has entered the analytical validation phase for its ovarian cancer test, progressing toward an FDA 510(k) submission expected in early 2027.

Proteomics International has won a key US patent for its PromarkerEndo blood test, bolstering its commercial foothold in the world’s largest healthcare market. The patented technology offers a non-invasive, accurate diagnosis of endometriosis, a condition that currently takes years to detect.

Lumos Diagnostics has received a A$709,837 cash refund from the Australian Government’s R&D Tax Incentive, bolstering its investment in proprietary point-of-care diagnostic technologies.

Nexsen has locked in over $1.5 million in non-dilutive funding through a national research partnership, accelerating manufacturing scale-up and platform optimisation for its rapid diagnostics technology.

Australian Clinical Labs appoints Greg Horan as Group CEO effective August 2026, marking a leadership transition after a decade under Melinda McGrath. Horan’s healthcare and operational expertise positions ACL for its next growth phase.

Pacific Edge reported a steep 47% revenue drop in FY26 following Medicare coverage loss but secured a draft Medicare policy covering its Cxbladder tests and raised NZ$25.4 million to fuel growth and commercial execution.