Latest Medicare News

Proteomics International is pivoting from research to disciplined commercial execution of its proteomics-based diagnostic tests, focusing on distributor partnerships and reimbursement pathways in Australia and the US.

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.

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.

Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.

EBR Systems marked a pivotal transition in 2025 with FDA approval of its WiSE CRT System and the initiation of U.S. commercial implants, generating $1.6 million in revenue. Despite this progress, the company reported a net loss of $48.8 million and completed a significant capital raise to support ongoing growth.

Rhythm Biosciences has achieved a significant regulatory milestone with NATA accreditation for its ColoSTAT® blood-based colorectal cancer test, enabling its commercial rollout in Australia and strengthening reimbursement prospects.

PainChek Limited reported a half-year loss of AUD 4.7 million but achieved a major regulatory milestone with FDA clearance for its Adult App, unlocking significant US market opportunities. The company also completed a share consolidation and raised capital to support growth.

Lumos Diagnostics reported a 74% increase in its half-year loss to US$4.88 million, despite strong progress with its FebriDx diagnostic test and a landmark US distribution agreement. The company awaits a critical FDA decision that could unlock significant revenue growth.

Cyclopharm Limited reported a 17% revenue increase to a record $32.3 million in 2025, powered by a 226% surge in US Technegas sales. The company is accelerating its US rollout with plans for up to 300 installations in 2026, while advancing clinical trials beyond pulmonary embolism.

Epiminder Limited has reported a $21.7 million loss for the half-year ending December 2025, alongside a successful $125 million IPO that fuels its commercialisation of the FDA-approved Minder epilepsy monitoring device.

Integral Diagnostics Limited has reported a robust half-year performance, with revenues soaring 55.6% and EBITDA nearly doubling, driven by strong patient volume growth and successful integration of Capitol Health. The company also declared a fully franked interim dividend of 3.3 cents per share.

A recent expert panel convened by Novitas has strongly endorsed Pacific Edge’s urine-based Cxbladder tests for hematuria evaluation, recommending Medicare coverage based on robust clinical evidence and patient care benefits.