17 Mar MEDIA RELEASE: Atomo Diagnostics Issues Supplementary IPO Prospectus in Response to Multiple COVID-19 Rapid Blood Test Requests
SYDNEY Australia, 17 March 2020: Australian rapid blood test company Atomo Diagnostics Limited (ACN 142 925 6840) said today it was working with potential OEM customers to develop rapid self-tests for COVID-19 that could deliver results to patients in as little as 15 minutes, and be deployed in the field without the need for expensive laboratory equipment or extensive clinical expertise.
These newly developed coronavirus blood tests would be integrated with Atomo’s existing rapid diagnostic test (RDT) devices which are currently used to deliver rapid blood testing and self-testing for a range of applications including HIV screening and differentiating between viral and bacterial upper respiratory infections. The Atomo HIV Self-Test is the only rapid blood test to have been approved by the Australian Therapeutic Goods Administration (TGA) for use as a self-test, as well as being prequalified by the World Health Organisation.
The COVID-19 blood tests using the Atomo device will work by collecting and delivering a controlled volume of blood to test for infection by detecting the presence of antibodies generated by the human body in response to the virus. The test is intended for use by individuals for self-testing and can also be used by health professionals to screen patients. Importantly, as a self-test, it would remove the need for medical staff to work in close proximity to potentially infected individuals to perform a test.
Unlike current laboratory or professional use tests, rapid blood tests using an integrated self-test Atomo device are suited to distribution to the broader community and do not require clinical expertise or expensive laboratory equipment.
Atomo Diagnostics founder and CEO John Kelly said, “In the past few weeks we have received urgent inbound enquiries from several diagnostic companies based in Europe, the USA and China that have recently developed blood-based rapid antibody tests for COVID-19. These parties are eager to move quickly to evaluate the potential for COVID-19 self-tests to be commercialised by utilising Atomo’s proven self-test devices. Discussions have already progressed to preliminary documentation with two of the parties, and technical and commercial engagement is ongoing.
We’ve demonstrated our ability to deliver reliable results for challenging diseases like HIV within 15 minutes and look forward to working with our international partners to deliver similar outcomes for consumers and healthcare professionals at a time when the need for greater testing of the COVID-19 virus is urgently needed.”
Atomo intends to raise $30 million at 20 cents per share via its current initial public offering and is listing on the Australian Securities Exchange, expected in April 2020. The Company has today (Tuesday 17 March 2020) issued a Supplementary Prospectus detailing commercial and technical discussions with global diagnostic companies seeking to access its rapid test devices as a platform for their own blood-based COVID-19 tests.
Mr Kelly said emergency use regulatory approvals processes have been implemented by a number of national regulators to help fast-track test approvals with a view to significantly reducing time to market for COVID-19 tests.
One test being considered for commercialisation on the Atomo RDT device has already secured Emergency Use Approval by the China NMPA (National Medical Products Administration, formerly the China FDA) as a professional use RDT that could be integrated for use with Atomo’s self-test device, and another has undergone clinical evaluation as a professional use RDT in China with its diagnostic efficacy established. Another test is currently subject to independent clinical evaluation in France and Spain.
Mr Kelly said Atomo has set aside an initial 300,000 units in inventory to be made available for COVID-19. Atomo is looking to accelerate its manufacturing capabilities subject to one or more of the device companies it is working with obtaining approval for a rapid COVID-19 test that uses Atomo’s self-test device.
Major shareholders in Atomo include billionaire property developer Lang Walker, former Macquarie Bank Chief Executive Officer Allan Moss and the Bill and Melinda Gates Foundation-backed social impact investor Global Health Investment Fund.
Canaccord Genuity is Lead Manager for the IPO.
The Atomo Prospectus and Supplementary Prospectus are available via www.atomodiagnostics.com. A hard copy of the Prospectus is available free of charge during the offer period to any person in Australia by calling the Atomo offer information line on 1800 812 642 (within Australia) or +61 1800 812 642 (outside Australia) between 8.30am and 5.30pm (AEDT) Monday to Friday (business days only). Offers of Atomo shares are made under the Atomo Prospectus. A person should consider the Atomo Prospectus and Supplementary Prospectus in full in deciding whether to acquire shares. Anyone who wants to acquire Atomo shares will need to complete the application form accompanying the Atomo Prospectus.
For more information, please contact:
Phone: +61 408 677 734
Phone: +61 401 922 279