A new Australian precision medicine company, Gene S Dx Pty Ltd, has been formed to scale an Australian pharmacogenomics platform in a three-way partnership between industry, research and the scientists who built it.
Gene S Dx is owned equally by Syngenis Labs Ltd, an integrated nucleic acid manufacturer, the Perron Institute for Neurological and Translational Science, and the founders of Gene S, Dr Svetlana Baltic and Dr Suzanna Lindsey-Temple.
Dr Baltic continues as Chief Executive Officer and Dr Lindsey-Temple as Chief Medical Officer, and both join the board of the new company alongside Syngenis Labs Managing Director Thomas Hanly and Executive Director Gavin Ball. The full technical, software, quality and regulatory team transfers with the business.
Gene S Dx acquires the Rosa pharmacogenomics platform in its entirety and is named for chemist Rosalind Franklin. It pairs a next generation sequencing RosaMind assay with the RosaAnalyser interpretation and reporting software, so that a pathology laboratory can return a clinician ready report in two to three days from a single blood, buccal or saliva sample.
More than 99 per cent of people carry at least one genetic variant that changes how they metabolise medicines. Despite that, which medicine a patient receives, and at what dose, is still very largely settled by trial and error.
RosaMind was the assay used in the test kits for GENE-YD, a randomised controlled trial conducted at the Perron Institute in Western Australians aged 16 to 24 with moderate to severe depression, testing whether pharmacogenomic guided prescribing delivers better outcomes than prescribing on standard clinical guidelines alone.
“We built Rosa because the current approach asks the patient to carry the risk of getting it wrong, and for someone with severe depression every medicine that fails is months of their life,” Dr Svetlana Baltic, Chief Executive Officer of Gene S Dx Pty Ltd, said.
“What this partnership gives us is the one thing a small company cannot buy quickly: manufacturing at scale and deep nucleic acid science, sitting directly alongside our own.”
Syngenis Labs holds nucleic acid chemistry expertise, laboratory infrastructure, and the capacity to manufacture the oligonucleotide components of the Rosa test kits in Australia and to scale that manufacture as volumes grow.
“Diagnostics and therapeutics are converging, and pharmacogenomics is where that convergence reaches the patient first,” Thomas Hanly, Managing Director of Syngenis Labs Ltd, said. “We design and manufacture nucleic acids for a living, so we can sit alongside Svetlana’s team on panel design for the next indications and then produce the kits at volume, here, rather than watching the supply chain run offshore.”
The Perron Institute’s record in RNA therapeutics is world class. The exon skipping (antisense) therapies developed by Professors Steve Wilton AO and Sue Fletcher AO became the first treatment for Duchenne muscular dystrophy approved by the United States Food and Drug Administration.
The Institute’s Youth Mental Health program studies the biological differences and changes that shape mental health, treatment choice and outcomes, which is precisely the question RosaMind is built to answer. The Perron Institute led the GENE-YD trial and has worked with the Gene S team to generate the data for several years.
“We have worked with this team on the pilot GENE-YD trial, which is now expanding to an implementation study across metropolitan and regional WA,” Steve Arnott, Chief Executive Officer of the Perron Institute, said.
“Taking an ownership position rather than a research contract is a deliberate choice. We want this capability held in Western Australia, tested rigorously, and put to work for patients.”
The immediate priority is broadening clinician access to RosaMind through pathology laboratory partners. Pain management is first. Followed by Cardiac prescribing, with anaesthesia, infectious disease, oncology and animal health in the development pipeline. Gene S Dx will operate from Perth, Western Australia.
Article based on Syngenis media statement.
Media enquiries: Thomas Hanly, Managing Director, Syngenis Labs Ltd, tom@syngenis.com, 0433 124 288