Latest Diagnostics News

Rhythm Biosciences has completed the first commercial sale of its ColoSTAT® blood test for colorectal cancer, confirming the full clinical and logistical process is operational and ready for expansion.

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.

Micro-X has reached a key development milestone with the completion of its first Full Body CT laboratory test bench, securing a $1.6 million payment from US government partner ARPA-H and advancing its innovative medical imaging program.

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.

A new clinical study from Sichuan University confirms that TruScreen’s AI-enabled cervical cancer screening combined with high-risk HPV testing outperforms traditional cytology methods, reinforcing its global potential.

Rhythm Biosciences has inked a pivotal distribution agreement with UK-based Digistain Limited to introduce its geneType™ genetic test portfolio in Southeast Asia, starting with the Philippines. This marks Rhythm’s first commercial foothold in the region, setting the stage for broader expansion.

Radiopharm Theranostics reported a 44% increase in net loss to $27 million for the half-year ended December 2025, driven by expanded R&D spending. The company bolstered its cash reserves through a $35 million placement while progressing multiple clinical trials across its radiopharmaceutical pipeline.

Memphasys Limited has advanced its Felix™ System commercial rollout with key regulatory approvals and new international contracts, while trimming operating costs and narrowing losses in the first half of FY2026.

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.

4DMedical Limited’s half-year report reveals rapid commercial traction following FDA clearance of its CT:VQ™ imaging technology, alongside a $150 million institutional placement that bolsters its cash reserves for global expansion.

Artrya Limited reported a 44% increase in its half-year loss to $10.7 million as it transitioned from development to commercial operations in the US, securing FDA clearance and signing three foundation customers. An $80 million capital raise underpins its ambitious US expansion and ongoing product development.

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.