There is a word almost nobody outside a laboratory will ever use in conversation that many say could play a major role in the future of medicine. You couldn’t spell it after a few drinks, you’ve likely never actually heard of it and yet chances are you have already encountered one of its most practical expressions. You may have come across it unwittingly in a COVID-19 rapid test, in a PCR kit or in one of the new generation of precision medicines quietly changing how the world approaches disease.

The word is oligonucleotide or “oligo” for short. In a laboratory inside Bentley Technology Park in Perth’s southern suburbs, an unlisted company called Syngenis Laboratories is doing something no other organisation in Australia is commercially capable of doing: manufacturing them.

For most of the twentieth century, medicine worked by throwing chemistry at biology, a process that produced blunt instruments engineered to suppress pain, kill bacteria or slow tumours. That worked well enough because fundamentally, it involved chemical approximations of a far more precise underlying language. That language is “DNA” and “RNA”.

Every disease process, every cancer, every inherited disorder, every misfolded protein that aggregates until Alzheimer’s or perhaps Parkinson’s takes hold, begins as an event written in genetic code. For decades, medicine could read that code but couldn’t easily rewrite it. That era is ending.

While Syngenis does operate Australia’s only commercial Oligonucleotide manufacturing lab in Perth, its operation is limited because the company only manufactures research grade – rather than clinical grade - sequences, but that is all about to change. Working with government agencies, not-for-profits and Murdoch University, Syngenis is constructing a “Good Manufacturing Practice” (GMP) laboratory facility, the demanding quality standard required for DNA and RNA to be used in clinical applications involving human beings. When complete, it is expected to be the only commercial, human-grade short synthetic DNA and RNA manufacturing facility of its kind in Australia. A federal government discussion paper on RNA capability described Syngenis as the nation’s only commercial manufacturing facility for custom synthetic oligonucleotides and while the technology does exist elsewhere, the global map of GMP-grade nucleic acid manufacturers is a short list. That list is mostly clustered in the United States, Europe and China. Australia does not appear on it…yet.

The financial stakes are considerable too. The Australian Government’s R&D Tax Incentive rebate scheme, administered by the ATO, provides a 43.5 per cent refundable grant for monies spent on eligible R&D activities. That grant has ushered billions back into the hands of some of the most innovative research and development companies in Australia. While the scheme is one of the most generous research and development schemes in the world, its guidelines nonetheless make it very difficult to claim for work that can be done domestically but is sent offshore. Syngenis estimates approximately $160 million worth of GMP-grade oligonucleotide work leaves Australia each year, with much of it heading to laboratories in China, the United States and Europe and most, if not all of it currently claimed back via the Australian Government R&D rebate scheme.

Enter Syngenis, who says a local GMP-approved facility changes that equation entirely. The company believes it could trigger a significant and rapid shift in that work returning onshore and with potentially the only local, compliant lab, Syngenis would be in the box seat to pick up that multi-million-dollar work stream. For local biotech researchers, the advantages of a domestic supplier go beyond cost. Intellectual property control is tighter, turnaround times are shorter and the compliance argument alone may be enough to redirect substantial volumes of work that currently drift overseas when programs get serious. And if all of that is not enough, continued access to the Australian Government R&D grant that favours local suppliers will likely prove irresistible.

Think of an oligonucleotide as a very short, very specific molecular key designed to find and bind to exactly one genetic sequence. Once it binds, depending on its design, it can detect a disease, silence a harmful gene, carry a therapy to the right tissue, or guide an editing system to the right address in the genome. The same manufacturing capability underpins diagnostics, gene therapy, CRISPR applications and RNA therapeutics. It could also be used as an aptamer-based point-of-care test that could one day deliver results in just minutes from a finger prick at a pharmacy counter, potentially eating the lunch of established bloodwork labs.

Syngenis has structured itself around three reinforcing pillars: manufacturing, discovery and diagnostics. Manufacturing is the revenue engine today, with a working research-grade laboratory already servicing around forty paying customers, including several academic institutions and biotech companies across Australia and New Zealand. Discovery uses AI-supported laboratory science to develop proprietary diagnostic assets, with the lead program targeting Alzheimer’s and Parkinson’s disease, conditions where detecting molecular signatures years before clinical symptoms could transform patient outcomes. Diagnostics is the commercial deployment layer, beginning with third-party point-of-care tests for conditions including potentially prostate cancer, kidney disease and infectious disease, building the distribution infrastructure that will carry Syngenis’s own tests to market.

Simply put, manufacturing supplies the materials discovery requires. Discovery generates the targets before diagnostics validate and create the channel through which proprietary tests are monetised. The same regulated infrastructure underpins all three.

Notably, the people behind Syngenis are not typical of an early-stage laboratory company.

Founder Professor Rakesh Veedu is an internationally recognised authority in RNA therapeutics and nucleic-acid manufacturing, whose synthesis work in Western Australia was formalised as a commercial operation in late 2020, after six years of running the service out of Murdoch University. He is the scientific engine at the company’s core.

The company was shaped from inception by Professor Marvin Caruthers, a name that carries serious weight in this field. Caruthers invented the chemistry underpinning all modern synthetic DNA and RNA manufacturing, co-founded Applied Biosystems and Amgen Pharmaceuticals and received the United States National Medal of Science. Notably, the lab was originally running the service at Murdoch University with funding from the prestigious Perron Institute.

The Advisory Board Chair, Dr Sudhir Agrawal, founded Idera Pharmaceuticals and holds more than 400 patents in oligonucleotide therapeutics, a body of work that spans the full arc of the field’s commercial development.

Chairman Dr Martin Blake and Executive Director Gavin Ball both bring a strong track record in ASX-listed businesses and Ball, along with recently appointed MD Tom Hanly, was a founding director of another diagnostic biotech that listed on the ASX recently at a 50 per cent premium to its issue price.

Hanly has a record of taking early-stage science and building it into commercially viable platforms and is best known for his previous role developing ASX-listed Singular Health.

The investor register reflects the same seriousness of intent. The Perron Institute for Neurological and Translational Science holds a strategic stake alongside Primewest Property Group behemoth founders John Bond, David Schwartz and James Litis.

The market Syngenis is looking to muscle into is substantial, too. The global oligonucleotide synthesis market is forecast to exceed US$15 billion by 2030. DNA diagnostics are expected to reach US$17 billion and point-of-care diagnostics are projected at US$125 billion by 2034, with Asia-Pacific the fastest-growing region across all segments.

Syngenis is planning an ASX listing in the future as the next step in its development. And while GMP construction is complex, diagnostic pathways are long and Alzheimer’s research in particular is challenging, unlike many biotech hopefuls out there that are already ASX-listed, Syngenis has partially validated its offering with existing revenues from current customers…and that list is also impressive.

In plain English, Syngenis makes custom genetic building blocks that help scientists find, measure, target and modify disease-related biology. Do that well enough, add the systems needed for clinical work and the company is no longer just a Perth lab making short strands of DNA and RNA. It becomes part of the domestic manufacturing backbone for Australia’s next wave of diagnostics and precision medicines.

For now, Syngenis’ laboratory in Bentley is largely flying under the radar, but an ASX listing will no doubt change all that and when it does, its impressive array of investors, staff and customers will likely spark the interest of the Australian biotech glitterati.

Is your ASX-listed company doing something interesting? Contact: matt.birney@wanews.com.au