Latest Diagnostics News

Singular Health boosted its US presence by deploying 500 additional 3DICOM MD® licenses to Provider Network Solutions, securing FDA 510(k) clearance for its cloud platform, and launching education pilots with Miami-Dade schools and Florida International University.

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.

Radiopharm Theranostics (ASX: RAD) has completed enrolment in its Phase 2b RAD 101 brain metastases imaging trial with interim data showing 90% concordance with MRI, while progressing early-stage trials of therapeutic candidates RAD 202, RV-01, and RAD 402. The company reported a $19.2 million cash balance at quarter end, down from $34.5 million, with a net operating cash outflow of $14.9 million driven by milestone-related R&D and staff costs.

Singular Health has received a US$500,000 payment from Provider Network Solutions following the deployment of an additional 500 3DICOM MD® licenses, marking progress in commercial adoption and cost-saving benefits within a major US healthcare network.

BCAL Diagnostics has expanded its Avantect cancer blood tests nationally through major pathology networks, generating $88,000 in Q3 revenue from 91 tests. The company also submitted an initial Medicare reimbursement application for pancreatic cancer detection and is preparing to launch an enhanced BREASTESTplus 2.0 test in early 2027.

Invion Limited is broadening its non-melanoma skin cancer trial to include basal cell carcinoma patients following encouraging safety and efficacy data from squamous cell carcinoma cohorts, targeting the largest skin cancer segment.

Compumedics maintains robust sales momentum but faces FY26 revenue timing challenges due to MEG installation delays and a cautious Somfit D rollout. The company expects solid year-on-year growth and positions for improved execution in FY27.

Far East Gold Limited reveals promising metallurgical test results from its Idenburg project, showing gold recoveries around 95% using conventional processing methods. These early findings suggest a straightforward processing route but remain preliminary pending further testing.

Lumos Diagnostics has secured a key FDA 510(k) clearance with CLIA waiver for its FebriDx rapid test, unlocking a US$1 billion-plus market opportunity and triggering milestone payments exceeding US$6 million. The company reported a 37% revenue jump in Q3 FY26, supported by a A$20 million placement and ongoing clinical and development projects.

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.

Axel REE Limited has achieved a key operational milestone in its in situ recovery (ISR) development at the Woolrich deposit within the Caladão Project, confirming strong rare earth element leach performance under low-impact magnesium sulphate conditions.

Radiopharm Theranostics has reported encouraging initial results from the Phase 1 HEAT trial of its novel HER2-targeted radiopharmaceutical, 177Lu-RAD202, highlighting tumor uptake and a clean safety profile at the lowest dose with dose escalation approved.