Latest Medical Diagnostics News

Proteomics International Laboratories has achieved the prestigious CAP accreditation for its US lab and installed a new mass spectrometry platform, setting the stage for the 2026 launch of its Promarker diagnostic tests in America.

Cleo Diagnostics has raised $5 million to support the U.S. commercial launch of its Pre-Surgical Ovarian Cancer Test and accelerate development of a mass screening test, signaling strong investor confidence in its technology.

Proteomics International's PromarkerD blood test shows clinically meaningful accuracy in predicting diabetic kidney disease among Aboriginal Australians, matching performance in non-Indigenous populations. This advancement offers a promising tool for early intervention in a high-risk group.

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.