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Officially Australian Made

November 2022

Since our foundation, one of ZiP Diagnostics’ primary goals has been to build capability for advanced manufacturing in Australia. By designing and manufacturing innovative diagnostic products in Melbourne in our ISO13485 accredited facilities, ZiP is contributing to Australia’s sovereign manufacturing capabilities.

In recognition of our capabilities and achievements, ZiP Diagnostics was recently authorised to bear the Australian Made Logo on its products. This logo is a true mark of Aussie authenticity and ZiP’s products will proudly bear the green and gold kangaroo.

 
 

ZiP Diagnostics flexes its manufacturing muscle

October 2022

Even prior to the pandemic, ZiP Diagnostics understood the supply-chain risks that existed for Australia’s in vitro diagnostic test needs. Despite Australia’s proud legacy of scientific innovation, we still lag behind in manufacturing critical medical diagnostic supplies.

ZiP is committed to creating new technologies that deliver better point-of-care health outcomes but also to ensure Australian production of those tests. This will ensure domestic supply and also help to grow the number of local, highly-skilled jobs.

 

Over the last three years, ZiP has grown to a team of over 30 people. Many are responsible for GMP protein production, cartridge manufacturing and quality control. This production includes in-house design of automated manufacturing modules using artificial intelligence for product quality control.

 

Current production is being scaled-up to support several clinical trials and will enable production in excess of 50,000 tests per year. Further scale-up is underway to reach production capacity of 1 million tests per year.

It has been truly exciting to see such a hive of activity on the production floor in support of the clinical trials. Jack Richards, our Scientific Director and Founder was elated; “This is a great achievement and a very important milestone. It has been wonderful to see how everyone has rallied to get this job done. ZiP has always been committed to products that will bring better health care to people that need it most.”

 

Always working hard behind the scenes, our production team has a lot to be proud of and are already planning the further expansion of the manufacturing capabilities for ZiP’s imminent market entry.

*The ZiP-CoVx-P2 test is not approved for use in all markets. 

(Left) ZiP-CoVx-P2* test cartridge pack. (Right) ZiP Diagnostics manufacturing team.

 

ZiP Diagnostics heads to Africa to conduct clinical trials for its ZiP-CoVx-P2* point-of-care test

September 2022

ZiP Diagnostics has developed a molecular POC test for screening and diagnosis of SARS-CoV-2. This test was designed primarily for resource-limited settings where traditional laboratory-based instruments may be challenging to operate. Due to the proprietary nature of the assay design, ZiP’s assay is cost-effective and is faster than traditional laboratory-based RT-PCR methods.  

The British Society for Antimicrobial Chemotherapy (BSAC) has funded ZiP to evaluate this test in Africa. This week Dr Charles Narh, a post-doctoral researcher originally from Ghana, will commence the field validation study of ZiP’s new high-sensitivity SARS-CoV-2 nucleic acid point-of-care (POC) test.  

The study will be conducted in close collaboration with the West African Centre for Cell Biology of Infectious Pathogens (WACCBIP), Biomedical and Public Health Research Unit of the Water Research Institute (Council for Scientific and Industrial Research) and the World Health Organisation HIV/Influenza Reference Laboratory at Noguchi Memorial Institute for Medical Research (NMIMR). These organisations have been spearheading Ghana’s SARS-CoV-2 testing and sequencing responses in communities across the entire country. 

Charles will spend up to two months in Ghana to assess the clinical sensitivity and specificity of our test and will compare the performance to that of RT-PCR. The data generated will inform the utilisation of the ZiP-CoVx-P2 assay for SARS-CoV-2 testing in low-middle-income countries. 

*The ZiP-CoVx-P2 test is not approved for use in all markets. 

 

ZiP Diagnostics presents at AusMedtech 2022

May 2022

ZiP Diagnostics made its first conference appearance at the recent AusMedtech 2022.

AusMedtech was a two-day conference (25-26 May) which showcased Australia's flourishing medtech network. There were over 450 Australian and international delegates present to discuss this year's theme of 'Medtech and Manufacturing'.

There was significant interest at the ZiP Diagnostics' booth, with delegates keen to see an Australian-made molecular point-of-care test platform. All main components of the test have been designed, developed and manufactured in Melbourne. ZiP's PC2 laboratory and manufacturing clean rooms are based in Collingwood.

The ZiP-CoVx-P2* test provides a point-of-care result for SARS-CoV-2 within 30 minutes. Clinical trials are currently underway and aims to have performance equivalent to lab-based PCR. Regulatory submissions to Australia's TGA and Europe's IVDR are in preparation.

*The ZiP-CoVx-P2 test is not approved for use in all markets. 

ZiP representatives in attendance: Mr. Bill Hopper (Technical Director), Dr. Hanh Nguyen (Research Officer), Dr. Khashayar Farrokzhad (Senior Research Officer), and Ms. An Le (System Scientist).

 
 

ZiP has secured a prestigious grant from the British Society of Antimicrobial Chemotherapy (BSAC) to assess its new COVID point-of-care test in Ghana

October 2020

Doctor Charles Narh, who leads the genetics and bioinformatics team at ZiP, will lead the BSAC field validation project. Doctor Narh, who studied for his PhD at the University of Melbourne, is originally from Ghana and has extensive field experience in researching and implementing programs for infectious diseases in Ghana. The project will partner with Dr Lydia Mosi and colleagues at the Noguchi Memorial Institute for Medical Research and the West African Centre for Cell Biology of Infectious Pathogens, who is spearheading Ghana’s response to the COVID-19 pandemic.

ZiP has recently developed a low-cost and easy to use point-of-care COVID-19 test that delivers a result in less than 30 minutes. It provides high sensitivity detection of active infection with SARS-CoV-2 virus, comparable to the polymerase chain reaction (PCR) laboratory test. The objective of ZiP’s point-of-care platform is to provide real time access to test results and a test capability that can be used at a community level without the need for a laboratory.​ 

“We are delighted to receive this BSAC grant as it provides valuable assistance with funding for the validation and implementation of ZiP’s technology in my home country of Ghana, which at this stage is not adversely affected by COVID-19.” said Doctor Narh.

ZiP awarded $750k commercialisation grant

April 2021

ZiP Diagnostics has been announced as one of the successful recipients of the Department of Industry, Science and Technology, Accelerating Commercialisation grants scheme, receiving $750,000 to establish manufacturing facilities for customised protein production and commercialisation of low cost, high sensitivity molecular diagnostic tests. 

The Minister specifically identified two projects that had impressive health benefits and outstanding commercial potential. ZiP was one of these with the Minister stating “… the ZiP system promises to vastly reduce the amount of time required for infectious diseases results to be confirmed…”

Dr Jack Richards, ZiP Scientific Director, was very pleased to receive the grant, “This grant will provide ZiP with important funding to ramp-up our Collingwood production facility and to provide a unique domestic capability to produce low-cost novel point-of-care molecular diagnostics for infectious diseases, including COVID-19, for Australia and world markets."

ZiP secures $600k federal grant for COVID-19 test

19 July 2020

Federal Minister for Health, the Hon Greg Hunt, made the announcement today, revealing details of the third round of grants from the $45 million BioMedTech Horizons (BMTH) program.

“We are delighted to receive this BMTH grant as it provides valuable funding for the development of ZiP’s technology and will allow us to secure regulatory approval in a shorter time frame than originally envisaged,” said ZiP Technical Director Bill Hopper.

All key elements of the ZiP technology are made locally ensuring Australia is less susceptible to global supply chain issues for diagnostic equipment. The test regime is suitable for use across many industry and community sectors including government, health, travel, defence, education, mining, industrial, commercial and sport.

“This innovative technology and our local production capacity means ZiP is ideally placed to play a major role in the identification, containment and management of COVID-19 in Australia,” Mr Hopper said.

ZiP starts pre-clinical testing of SARS-CoV-2 test system

June 2020

ZiP started pre-clinical testing of its SARS-CoV-2 test system at Royal Melbourne Hospital with the Victorian Infectious Diseases Reference Laboratory (VIDRL) in early June 2020. Pre-clinical testing is being conducted to complete commercial development of the system. 

ZiP is planning to apply for Therapeutic Goods Administration, TGA approval for its SARS-CoV-2 test systems with validation of its at scale production facilities.

FIND contract for CT-NG development

October 2019

Axxin supported by ZiP Diagnostics have been awarded a contract with the Geneva-based Foundation for Innovative New Diagnostics (FIND) to develop and commercialise a CT-NG (chlamydia and gonorrhoea) point-of-care test system. 

The Phase 1 proof-of-concept work required rigorous pre-clinical testing including extensive sensitivity and specific testing. The testing was conducted in collaboration with the Victorian Infectious Diseases Reference Laboratory (VIDRL). The success of this work has led to awarding of a phase 2 diagnostic contract.