Latest Medical Diagnostics News

Nexsen Limited has successfully completed a pivotal FDA Pre-Submission meeting for its StrepSure® diagnostic, significantly reducing regulatory risks and advancing its entry into the large US maternal health market.

Rhythm Biosciences has completed the first commercial sale of its ColoSTAT® blood test for colorectal cancer, confirming the full clinical and logistical process is operational and ready for expansion.

Rhythm Biosciences has achieved a significant regulatory milestone with NATA accreditation for its ColoSTAT® blood-based colorectal cancer test, enabling its commercial rollout in Australia and strengthening reimbursement prospects.

Rhythm Biosciences has inked a pivotal distribution agreement with UK-based Digistain Limited to introduce its geneType™ genetic test portfolio in Southeast Asia, starting with the Philippines. This marks Rhythm’s first commercial foothold in the region, setting the stage for broader expansion.

Lumos Diagnostics reported a 74% increase in its half-year loss to US$4.88 million, despite strong progress with its FebriDx diagnostic test and a landmark US distribution agreement. The company awaits a critical FDA decision that could unlock significant revenue growth.

Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.

Lumos Diagnostics has hit a key enrollment milestone in its BARDA-funded paediatric study for FebriDx®, unlocking a US$720,000 payment and edging closer to FDA expansion.

Rhythm Biosciences reported a $2.26 million half-year loss as it advances ColoSTAT into commercialisation and expands geneType partnerships, signalling a pivotal phase for the ASX-listed medical diagnostics company.

Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.

Rhythm Biosciences has inked a non-exclusive distribution agreement with 4Cyte Pathology to integrate its ColoSTAT® colorectal cancer blood test into a vast pathology network across eastern Australia, aiming to boost adoption and accessibility.

Rhythm Biosciences has taken a significant step toward commercialising its ColoSTAT blood test for colorectal cancer by enrolling the first physician in its Access Program, marking the transition from clinical trials to routine clinical use.

Rhythm Biosciences has secured a multi-year commercial manufacturing agreement with US-based Quansys Biosciences to produce ColoSTAT® reagent kits, paving the way for broader market rollout of its colorectal cancer diagnostic test.