The newly developed coronavirus blood tests would be integrated with Atomo's existing rapid diagnostic test platform currently used for HIV screening and differentiating between viral and bacterial upper respiratory infections
The illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses (Credit: CDC/ Alissa Eckert, MS; Dan Higgins, MAM)
Australian rapid blood test company Atomo Diagnostics Limited said today it was working with potential original equipment manufacturing customers to develop rapid self-tests for COVID-19 that could deliver results in as little as 15 minutes, and be deployed without the need for expensive laboratory equipment or extensive clinical expertise.
The newly developed coronavirus blood tests would be integrated with Atomo’s existing rapid diagnostic test platform currently used for HIV screening and differentiating between viral and bacterial upper respiratory infections. The HIV self-test is 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 test using the Atomo device will work by collecting and delivering a small controlled volume of blood to test for infection by detecting the presence of antibodies generated in the 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. 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 list on the Australian Securities Exchange in mid-April 2020. The Company has 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 rapid diagnostic test device had already secured emergency use approval by the China National Medical Products Administration (NMPA) as a professional use rapid diagnostic test that could be integrated for use with Atomo’s self-test device. Another has undergone clinical evaluation as a professional use rapid diagnostic test in China with its diagnostic efficacy established. Another test is currently subject to independent clinical evaluation in France and Spain.
Mr Kelly said Atomo had 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.
Source: Company Press Release