Latest Medical Diagnostics News

Rhythm Biosciences has begun commercialising ColoSTAT®, its blood-based colorectal cancer diagnostic test, following an updated ISO15189, 2022 accreditation. The test offers a new option for symptomatic patients where stool-based screening is unsuitable.

Nexsen Limited has appointed internationally acclaimed surgeon-scientist Professor Shekhar Kumta to its board, aiming to fast-track clinical validation and regulatory approval for its rapid diagnostic platforms ahead of a planned 2026 market entry.

Proteomics International secures a key Medicare reimbursement rate for its PromarkerD test, a predictive diagnostic for diabetic kidney disease, marking a critical step in its US commercial rollout.

Pacific Edge reports a $19.1 million net loss for the first half of FY26 amid Medicare coverage loss but positions itself for a Medicare-led recovery with strong clinical evidence and a key advisory committee meeting set for February 2026.

Proteomics International secures half a million dollars from the Western Australian Government to accelerate commercialisation of PromarkerEndo, a groundbreaking blood test for early endometriosis diagnosis.

Nexsen Limited has successfully completed an $8 million IPO and ASX listing, while advancing its kidney diagnostic tests and initiating clinical trials for its GBS Rapid Sensor targeting expedited FDA approval.

TrivarX has reported promising interim results from its US veteran-focused mental health trial using ECG technology, while progressing a strategic acquisition of novel brain tumor imaging IP to broaden its diagnostic portfolio.

Cleo Diagnostics has successfully completed Stage 1 of the Medical Device Single Audit Program, marking a significant step toward FDA submission and global commercialisation of its ovarian cancer test.

Atomo Diagnostics reported strong commercial momentum in Q1 FY26, highlighted by a key FDA submission for its FebriDx test and a successful capital raise of $1.3 million. The company also showcased promising clinical data for its Active Syphilis test and expanded its HIV Self-Test distribution channels.

Rhythm Biosciences reports strong Q1 FY26 progress, securing strategic partnerships and advancing commercial readiness for its ColoSTAT® colorectal cancer test alongside robust growth in its geneType platform.

Proteomics International Laboratories has secured ISO 15189 certification and launched PromarkerD and PromarkerEso nationally in Australia, while advancing US reimbursement pathways and preparing for leadership transition.

Nexsen Limited has initiated clinical trials for its StrepSure® GBS Rapid Sensor, a next-generation diagnostic device aimed at improving maternal health outcomes. The trial's success could pave the way for regulatory approval and early market penetration by the second half of 2026.