Biotechnology
Latest news, analysis, and insights from ASX biotechnology companies
Cleo Diagnostics Selects Bio-Techne’s US Laboratory for Pivotal Ovarian Cancer Test Validation
Cleo Diagnostics taps Bio-Techne's US lab for pivotal validation of its pre-surgical ovarian cancer test ahead of a 510(k) FDA filing in H1 2027.
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Optiscan Imaging Advances InForm Device with Digital Pathology Study
Optiscan Imaging advances ACL study, >80 cases imaged with InForm slide-free digital pathology, accelerating clinical validation and rollout.
Biome Australia to Launch Larger Format of Best-Selling Probiotics Range
Biome Australia unveils larger two-month probiotic formats, boosting stock-keeping units and onshore manufacturing to drive demand in 2027.
Echo IQ to Review Regulatory Path after EchoSolv HF Application Misses FDA Clearance
Echo IQ studies next steps after FDA finds EchoSolv HF 510(k) not substantially equivalent; will engage FDA directly while EchoSolv AS stays cleared.
Emyria Prepares First Sydney Clinic for September Launch
Emyria to open Sydney clinic in Sept 2026, expanding NSW reach; 20 therapists, 4 psychiatrists (2 authorised prescribers) ready; patients approved.
Dimerix Secures Non-Dilutive Funding for Key Kidney Disease Programs
Dimerix secures up to A$34m non-dilutive funding to progress two kidney programs; half drawn now, funding ACTION3 Phase 3 and DMX-652 Phase 2.
EMVision Medical Devices Prepares Study to Support Remote Use of emu Bedside Brain Scanner
EMVision moves to remote stroke care with emu bedside scanner; regional study protocol set, telehealth-enabled diagnosis could shift rural care (ASX: EMV).
Cleo Diagnostics to Commence Analytical Validation of Pre-Surgical Ovarian Cancer Blood Test
Cleo Diagnostics begins analytical validation of eight-biomarker pre-surgical ovarian cancer blood test after receiving 125 kits, advancing FDA submission.
AdAlta Partner to Provide Adapted CAR-T Mesothelioma Therapy in China under Special Access Scheme
AdAlta's EW-001 CAR-T gains China access under Lecheng scheme; BZDS1901 approved for mesothelioma at Ruijin Hospital, boosting ASX:1AD upside.
Vitrafy Life Sciences Enters US Cell and Gene Therapy Space with Cryopreservation Agreement
Vitrafy Life Sciences nets first North American cell/gene therapy deployment with Charter Medical to install its cryopreservation ecosystem (six-month term).
Racura Oncology Opens Korean Recruitment for RC220 Phase 1 Solid Tumours Trial
Racura Oncology opens Korea recruitment for RC220 Phase 1 solid tumours trial, expanding to Ewha, Severance and Samsung Medical Center to accelerate enrolment.
Optiscan Launches US Study of InVue and InForm Imaging Devices for Head and Neck Cancer Surgeries
Optiscan kicks off US Mayo Clinic study of 35-patient InVue/InForm for head and neck cancer; real-time intraoperative imaging aims to back FDA submissions.