Pictured above: ZiP Diagnostics DNA-based molecular diagnostic tests rapidly respond to COVID-19 and other infectious diseases and will be manufactured in Australia.
With the support of BioMedTech Horizons (BMTH) funding, ZiP Diagnostics is giving Australia DNA-based molecular diagnostic tests vital to rapidly respond to COVID-19 and other infectious diseases.
Launched in 2019, ZiP Diagnostics is an Australian-owned, Melbourne-based biotech that develops and manufactures point-of-care diagnostics for infectious diseases for COVID-19, for workplaces such as hospital ICUs, GP clinics and aged-care homes that need accurate test results to remain COVID-safe. This ZiP Diagnostics test is not another Rapid Antigen Test, but a DNA-based molecular diagnostic that can rapidly identify symptomatic and asymptomatic people.
In 2020, the company secured a $600,000 grant through Round 3 of MTPConnect’s BioMedTech Horizons (BMTH) program – funds it has since used to develop and commercialise new point-of-care test products for various diseases, such as sexually transmitted infections and SARS-CoV-2, the virus which causes COVID-19.
At the time of the award, the COVID-19 pandemic was in its early days and highlighting the need for accessible, high-quality, rapid point-of-care tests and diagnostic options that were not confined to centralised laboratories. ZiP Diagnostics was already on its way to becoming the first Australian company to manufacture novel DNA based point-of-care tests that would meet domestic and international needs, and, with the support of BMTH funding, it has now developed fundamental platform technologies that can be applied to SARS-CoV-2, as well as other emerging infectious diseases.
Delivering accurate tests to ensure workplaces remain COVID-safe
According to Dr Jack Richards, ZiP Diagnostics’ Co-Founder and Director, the company’s capacity to produce COVID-19 tests locally will have a radical impact on the emerging market and potentially deliver dramatic health improvements and cost savings. “Hospital ICUs, GP clinics and aged-care homes need highly accurate COVID testing, which is low cost, easy and quick to administer, so they can keep people safe and their services operational. This is not something available in Australia right now,” said Dr Richards. “Rapid Antigen Tests, have their place, but they are not usually designed to screen asymptomatic people and do not deliver the accuracy these workplaces need to ensure they remain COVID-safe.”
Pictured, from left, Tori Mynard Associate Project Manager REDI Initiative, Dr Vishal Srivastava Director BMTH, Dr Gerard Gibbs Senior Director BMTH program and Dr Jack Richards Co-Founder and Director at ZiP Diagnostics during a visit to the company's Collingwood facilities earlier this year.
Though ZiP Diagnostics faced several pandemic-imposed disruptions during its early days, since its inception it has managed to expand from two employees to 30 highly skilled medtech development and manufacturing staff. It has also built and commissioned a new PC2 laboratory and clean room manufacturing facility in Collingwood, near Melbourne’s CBD. Here, the team can manufacture up to one million tests per year and produce good manufacturing practice (GMP) grade proteins to service this volume of production, with scope for further increases in scale.
Establishing such an operation understandably presented its share of technical challenges – many of which stemmed from the diversity of technologies required to bring a new point-of-care DNA-based molecular diagnostic test to market. For example, the need to track and respond to changes in microbial strains required ZiP Diagnostics to develop unique bioinformatic solutions to ensure new SARS-CoV-2 variants would be detected by its test.
Likewise, the company needed to ensure the tests performed using the wide heterogeneity seen with human samples. So, the ZiP team established clinical trials to enable collection of samples from test-negative individuals and systems to spike in controlled doses of microorganisms.
Challenges and a commitment to scaled-up manufacturing in Australia
Initial supply-chain challenges for critical reagents were overcome by establishing in-house production capabilities, including GMP production of critical proteins required for the assays. Test formulation stability also prompted the ZiP team to develop in-house expertise in lyophilisation (freeze-drying).
The company’s commitment to scaled-up manufacturing in Australia led the engineering team to design and assemble a range of cellular production units to perform the various functions required for assay dispensing, cartridge assembly, packing and quality control. Given the high regulatory hurdles associated with the human in vitro diagnostics market, ZiP established an ISO 13485-certified Quality Management System and assembled an in-house team to conduct high-quality clinical trials and regulatory submissions.
Having overcome these and other obstacles, ZiP Diagnostics obtained CE mark* regulatory registration for the use of its SARS-CoV-2 test in Europe (pending approval of the associated instrument) and is awaiting Therapeutic Goods Administration (TGA) approval in Australia in the next few months.
As the company’s Co-Founder and Director, Bill Hopper, said: “ZiP Diagnostics is an example of great Australian innovation with a focus on community need. Australia has a need to manufacture more effective COVID test alternatives, which deliver speed and accuracy outside of labs. We have the opportunity to bring PCR-grade testing to the people and facilities that need it most, including people who have COVID but are asymptomatic. For people who work in healthcare with high-risk patients – it will be a gamechanger.
“This is where the BMTH program funding proved to be extremely important for us; it provided direct support for many of these crucial activities to help our technology and business develop the momentum we needed,” said Mr Hopper.
Pictured, from left, outside ZiP Diagnostics in Collingwood near Melbourne CBD: Tory Mynard Associate Project Manager REDI Initiative, Dr Gerard Gibbs Senior Director BMTH program, Dr Jack Richards Co-Founder and Director ZiP Diagnostics, Dr Vishal Srivastava Director BMTH program, and Dr Bill Hopper Co-Founder and Director ZiP Diagnostics.
An immense amount of work and an inspiring journey to commercialisation
Senior Director BMTH program, Dr Gerard Gibbs says when he visited ZIP Diagnostics' facilities in Collingwood, he was astounded to see the immense amount of work that had been done over the very difficult period of the pandemic to develop and validate a molecular diagnostic and create a manufacturing facility.
“While a relatively modest contribution in ZiP Diagnostics overall development, the BMTH support provided an important catalyst that helped spin up many of these activities and put ZiP on the path to commercialisation, which was inspiring to see.”
Yet the future of ZiP Diagnostics is not dependent on SARS-CoV-2 alone. The team is directing its platform technologies to a wide range of other applications that have key clinical and public health needs in Australia and overseas, and is currently running four clinical studies, with further studies in the planning stages.
Forging its future success as an Australian-owned manufacturer, ZiP Diagnostics hopes to provide opportunities for the creation of highly skilled jobs, high-quality export products and cutting-edge technologies that will deliver the next generation of diagnostic testing.
To learn more: ZiP Diagnostics.
*The letters ' CE ' appear on many products that are traded on the single market in the European Economic Area (EEA ). The CE mark shows that the manufacturer has checked that these products meet European Union (EU) safety, health or environmental requirements.