ZiP Diagnostics: Fast, accurate infectious disease detection

Meet ZiP Diagnostics, the Aussie med-tech solving diagnostics’ great conundrum

ZiP Diagnostics received an Entrepreneurs’ Programme Accelerating Commercialisation grant of $750,000 and expert advice from i4 Connect to develop a fast, accurate infectious disease detection system at the point-of-care.

The virulent spread of the COVID-19 (SARS-CoV-2) virus demonstrated major flaws in many response systems, including point-of-care diagnostics. Existing Polymerase Chain Reaction (PCR) testing achieves accurate and reportable results but requires time- and labour-intensive processes.

Subsequently developed Rapid Antigen Tests (RAT) produce a fast user-initiated result, but with reduced levels of accuracy and limited ability to capture or analyse data. Australian-based ZiP Diagnostics is currently undergoing clinical trials to provide a simple-to-use, point-of-care solution that can produce a positive result in less than 15 minutes with equivalent performance to PCR testing, along with real-time data acquisition.

The test has recently obtained approval for use in Europe and is about to undergo assessment by the Therapeutic Goods Administration (TGA). The test platform can be adapted to suit several disease applications.

Initial manufacturing will focus on COVID-19 but will soon be applied to other respiratory viruses, sexually transmitted infections, viral hepatitis, mosquito-borne diseases and tuberculosis. ZiP Diagnostics is currently developing tests for the foot-and-mouth disease and monkey-pox outbreaks.

A joint project with a worthy cause

ZiP Diagnostics was co-founded in 2019 by Technical Director, Bill Hopper (Bill) and Scientific Director, Jack Richards . As an engineer and infectious diseases clinician, respectively, they quickly realised their complementary skills could achieve more in partnership than independently.

Their goal is to provide Australian developed and manufactured point-of-care solutions to communities in need across the world. Jack spent time in Africa in the early 2000s at the height of the HIV epidemic, treating malaria in children and combatting tuberculosis. This experience, as well as his long-term interest in tropical infectious diseases, particularly in low to middle-income countries, informed ZiP Diagnostics’ early planning.

2020: the virus that changed everything

Then the diagnostic landscape changed completely.

"When COVID-19 came along, everybody had to shift target and we decided to pitch our efforts towards trying to do something for the pandemic.”

As a result, ZiP Diagnostics' focus is to utilise Australian resources and skills to improve accessibility for coronavirus tests, and to use this momentum to further the development and locally-based manufacture of diagnostic testing kits for existing or new infectious diseases.

"A lot of the initial discovery work that gets done in Australian MedTech either gets bought out or taken overseas," Jack said. "It very rarely translates through to products that are manufactured in Australia."

A crucial step towards commercialisation has been the development of a sophisticated in-house manufacturing facility to produce tests in large volumes, in a significant step towards gaining regulatory approval. This also creates jobs and economic activity, with the potential to create a significant new export market.

The Entrepreneurs’ Programme Accelerating Commercialisation Grant – a critical piece of the jigsaw

With their collective background covering engineering, manufacturing, science and clinical medicine, Bill and Jack were well equipped to meet the technical challenges on the road to their goal. But the co-founders also needed to move quickly to establish and manage an operation capable of advancing from the research and development stage through testing and approvals, to local manufacturing and commercialisation.

That led ZiP Diagnostics to apply to the Entrepreneurs’ Programme Accelerating Commercialisation service, a move that has helped the company rapidly advance from the product development phase through to clinical trials and in-house manufacturing.

The next step is to gain inclusion on the Australian Register of Therapeutic Goods with the Therapeutic Goods Administration and, ultimately, to make the product commercially available.

"It's not just the technical aspects of making your product that is challenging; it's all the learning that goes with creating a company, building up a team, setting up

company structures."

Jack Richards

In addition to providing $750,000 in matched, undiluted funding to ZiP Diagnostics, the Entrepreneurs’ Programme Accelerating Commercialisation service also provided valuable mentorship from i4 Connect Facilitator, Andre Tan , an expert in launching new medical device products and services.

Andre also helped ZiP Diagnostics to access to a range of resources and government contacts that are invaluable to any fast-growing start-up.

"It's a very interactive process, going beyond just providing funding. It's about building the strongest company you can and getting expert help along the way."

Jack Richards

Testing system limitations exposed

Although the arrival of SARS-CoV-2 and subsequent global COVID-19 pandemic forced a significant shift for the emerging MedTech start-up, it also exposed the limitations of existing testing systems.

While PCR testing relies on an external pathology laboratory to generate results, an added benefit of ZiP Diagnostics’ COVID-19 test is that testing can be performed and results quickly achieved in conveniently located pop-up centres, including rural or remote locations.

"We feel that point-of-care [testing] is critical. We can see the benefits communities are gaining, even now, in their understanding and having readily accessible tests," Jack said.

“With a product on the market that brings a higher level of quality and accuracy, communities will be able to fast-track critical point-of-care solutions and therefore improve pandemic readiness across the globe in future.

“By empowering local businesses and developing local skills, we can create ecosystems for the domestic supply and global distribution of Australian-made products into communities that need it most.”

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