Latest Diagnostics News

Rhythm Biosciences marked a pivotal shift from development to commercial diagnostics in Q3 FY26, recording its first ColoSTAT® clinical sale and initiating NHS England evaluation while expanding geneType™ partnerships across Asia and Australia.

Artrya has fully integrated its Salix platform at Tanner Health, is preparing two more US sites for launch, and is finalising FDA submission for its Coronary Flow module, backed by a strong cash position of $76.6 million.

Microba Life Sciences reported a 99% year-on-year surge in core testing revenue for Q3 FY26, propelled by strong test volume growth and new clinic contracts in Australia and the UK. The company is advancing a major product release and negotiating a significant corporate transaction to bolster its financial position.

Control Bionics progresses its scalable distributor-led model in North America, inks a strategic US partnership for iOS speech devices, and gains German reimbursement eligibility for NeuroNode, while managing cash flow amid NDIS delays.

BlinkLab has completed onboarding all clinical sites for its pivotal FDA autism trial, enrolled the first participant, and launched a nationwide autism screening program in Morocco. A recent A$17.7 million capital raise will fund further trials and expansion into ADHD diagnostics.

Australian Critical Minerals (ASX:ACM) has launched its maiden diamond drilling campaign at the Flint Gold-Silver Project in Peru, backed by a $3 million capital raise and expanded land holdings. The drilling targets a 4 km high-sulphidation epithermal system, with advanced core logging technology deployed to accelerate geological insights.

Cleo Diagnostics (ASX:COV) has hit a major milestone by completing sample collection for its pivotal U.S. ovarian cancer trial, while progressing manufacturing and analytical validation steps toward FDA 510(k) submission.

TrivarX appoints Dr Danielle Meyrick as CEO to spearhead clinical trials and commercialisation of its novel stable isotope MRI brain cancer imaging platform, with Phase 1 studies on track for completion this year.

Argenica Therapeutics is progressing its ARG-007 drug toward a targeted Phase 2b trial for acute ischaemic stroke, leveraging AI for patient selection and securing key regulatory approvals, while maintaining a solid cash position of $8 million.

Atomo Diagnostics capitalises on Lumos Diagnostics’ FebriDx FDA CLIA waiver with over $2 million in new sales orders and a $3 million capital raise, expanding its global footprint and product pipeline.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

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.