Inoviq Ltd. and The University of Queensland (UQ) are expanding a collaboration to develop an exosome-based ovarian cancer screening test. Researchers from UQ identified and validated exosomal protein and micro-RNA (miRNA) biomarkers that when combined in its OCRF-7 algorithm showed more than 90% accuracy to detect stages I and II ovarian cancer in an independent 500-sample retrospective case-control study, Inoviq CEO Leearne Hinch told BioWorld.
In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
Pfizer Australia Holdings Pty Ltd. has made an offer to acquire digital health company Resapp Health Ltd. in all cash offer worth AU$100 million (US$74.25 million). The two companies have entered into a binding scheme that is contingent upon shareholder agreement and regulatory clearances in Australia. Shareholders will vote on the proposed acquisition in June, and directors have unanimously recommended that shareholders vote in favor of the acquisition.
Telix Pharmaceuticals Ltd. has in-licensed Eli Lilly and Co.’s olaratumab antibody, agreeing to pay $5 million up front for exclusive worldwide rights to develop and commercialize radiolabeled forms of the antibody for the diagnosis and treatment of human cancers.
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
Australia’s Therapeutics Goods Administration (TGA) cleared Orthocell Ltd.’s regenerative nerve repair device, Remplir, a biological scaffold that mimics the outer layer of the peripheral nerve to facilitate nerve repair.
Singular Health Group Ltd. entered a 50-50 joint venture in Macau that will explore the potential of Singular’s Scan to Surgery software for the East Asian market, which the company has long seen as a key opportunity for its 3D software and medical 3D printing ambitions.
New legislation providing a tax incentive for Australian medical innovations was introduced in Australia’s House of Representatives, and industry stakeholders are lauding the move. The measure, providing a special tax regime on income derived from patents, a “patent box,” will apply for income years beginning on or after July 1.
Saluda Medical Pty Ltd. raised $125 million in equity financing to commercialize and scale up its Evoke spinal cord simulation system for chronic pain and to advance its technology platform across an emerging portfolio of neuromodulation therapies.
PERTH, Australia – Nearly three-fourths of medical device stakeholders supported introducing mandatory reporting of medical device-related adverse events by health care facilities in Australia, but many raised concerns about data duplication and integrity.