Latest Diagnostics News

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.

INOVIQ Limited is on track to complete its EXO-OC™ ovarian cancer screening study by mid-2026 and is accelerating its CAR-exosome therapy program, supported by a strong cash position of A$11.9 million.

Echo IQ has taken a major step in its US expansion by deploying its AI-powered EchoSolv AS software at Mount Sinai Health System, one of America’s leading cardiovascular centres. This marks a key milestone in integrating AI into routine cardiology workflows at scale.

Cleo Diagnostics has kicked off a staged manufacturing program with Bio-Techne to produce ovarian cancer test kits, moving from clinical sample collection to analytical validation and FDA submission preparation.

Imricor Medical Systems advanced FDA clearances and expanded clinical trials in Q1 CY26, positioning for commercial growth despite higher operating cash outflows.