Latest Medical Diagnostics News

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

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.

TrivarX Limited reported a $1.26 million half-year loss as it completed the acquisition of Stabl-Im brain imaging IP and validated its mental health screening technology in veterans. The company raised $4.2 million to fund clinical development and expand its diagnostic portfolio.

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.

Sonic Healthcare has reported a robust half-year performance, with revenue climbing 16.6% to A$5.45 billion and net profit rising 10.9%, underpinned by organic growth and key acquisitions. The company maintains its full-year guidance amid ongoing US business rationalisation.

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.