Latest Medical Diagnostics News

Atomo Diagnostics has landed a significant $502,000 order for HIV self-tests destined for an African country, underscoring sustained demand for accessible diagnostics in the region.

Nexsen Limited has initiated FDA engagement for its rapid Group B Streptococcus diagnostic sensor, aiming for expedited US market entry, while bolstering its leadership team and scientific credentials.

Simble Solutions has acquired exclusive rights to a cutting-edge 3D zinc oxide nanosensor technology and completed a $2.5 million placement, positioning itself to expand its IoT platform into new safety and environmental monitoring markets.

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.

BlinkLab Limited has appointed its Co-Founder and CEO, Dr Henk-Jan Boele, as Managing Director to steer the company through its pivotal FDA 510(k) trial for its autism diagnostic technology. The move coincides with key board changes and signals a strategic shift as BlinkLab prepares for early commercialisation.

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.

Sonic Healthcare has reaffirmed its FY2026 EBITDA guidance with up to 13% growth, reported solid FY2025 financial results, and announced a strategic acquisition in Germany alongside notable sustainability progress.