PERTH, Australia – Australia’s Atomo Diagnostics Pty. Ltd. is preparing to raise AU$30 million (US$11.7 million) in an initial public offering on Australia’s Securities Exchange (ASX) that will enable it to ramp up manufacturing for rapid self-tests for COVID-19.

The Sydney-based company is working with several multinational diagnostics companies to develop the new COVID-19 blood tests, which would be integrated with Atomo’s existing rapid test platform currently used for HIV screening.

The HIV self-test delivers results in as little as 15 minutes and can be used and distributed without the need for laboratory equipment or clinical expertise. It is approved for sale in Europe and in Australia and has been prequalified by the World Health Organization.

The COVID-19 blood test using the Atomo device will work by collecting and delivering a small amount 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.

Atomo Diagnostics Founder and CEO John Kelly told BioWorld that the simple-to-use self-test could reduce stress on health systems and the need for people to visit clinics.

The first rapid test products commercialized by Atomo screen for HIV infection both for professional use and for self-testing. Atomo’s HIV self-test has regulatory approval in Australia and Europe and is prequalified by the World Health Organization. It received a $2.6 million grant from the Bill & Melinda Gates Foundation in 2016 to develop the HIV self-test.

Atomo has supply agreements with distributors including Mylan NV, and it also sells its devices to other diagnostic companies that commercialize the devices with their own diagnostic tests.

Platform developed for multiple infectious diseases

As a result of those partnerships, the company is well placed to get the COVID-19 self-test out to the global market quickly. It is in discussions with four major diagnostics companies, Kelly said, noting that the platform can be used for a number of infectious diseases.

“It was developed as an integrated consumer-friendly rapid test system. It was always developed as a platform, and we were always mindful that it had a lot of scope to be deployed in different blood-based test applications.”

HIV and malaria were the first tests to be rolled out, because there was a significant global need, and several of the company’s investors were focused on impacting global health.

The device itself can accommodate different rapid tests quite easily and can be readily adapted to deliver rapid antibody testing for COVID-19.

“We built up an acknowledgement in the market that we provide the best self-test solutions for point of care blood-based testing,” Kelly said. “On the back of that we’ve had a number of recent inbound inquiries from companies that have developed their own COVID-19 rapid blood-based assays, and they’re looking to partner with us or get access to our device so they can deliver reliable tests to doctors’ offices as well as self-test versions.”

“One of our potential partners has got their assay approved for emergency use with China’s regulator but it’s not approved on our device, so we’re going back to revalidate their assay on our device to see if we can get their test reapproved on our platform for easier and more reliable delivery to consumers and health care professionals.

“Our challenge is that the volumes these potential partners want to move into the market is putting our supply chain under pressure,” he said, noting that roughly 300,000 devices are ready to go, and a few hundred thousand devices are being manufactured.

A drop in the ocean

“But that is a drop in the ocean compared to global demand, and our challenge this year is to work out how quickly we can ramp up our capacity to support these different customers that are all working on the same problem, which is increasing the amount of reliable safe tests that can be deployed quickly for coronavirus.”

The CEO said the company was open to licensing and technology transfer arrangements to make the self-test technology widely available.

Atomo has manufacturing partners in China, South Africa and the U.S. to make the single-use disposable rapid test. There was some disruption to the China supply chain he said, but that is now on track.

The funds raised for the IPO will enable the company to ramp up its manufacturing.

“We’re able to make product and are looking to grow our capacity in a way that will make us more flexible in terms of being able to deal with shocks in the supply chain, and that may include bringing some manufacturing onshore and doing it in Australia.”

The IPO will offer 150 million Atomo shares priced at AU20 cents per share to raise AU$30 million. Cannacord Genuity (Australia) Ltd. is the lead manager. The IPO is expected to close on April 6.

Kelly said the company began planning the IPO in October 2019 before COVID-19 was even on the radar. He said there was a global demand for the HIV self-test, but now Atomo is switching gears to ramp up manufacturing capability for the COVID-19 test.

The diagnostic may be superior to current laboratory-based blood diagnostics in terms of accuracy, because it has been designed to simplify the test procedure and to reduce the number of user steps by integrating components into one intuitive, single-use device.

The device platform incorporates a built-in safety lancet, blood collection and delivery system, and integrated buffer delivery feature, which help to prevent user-related errors and improve test performance. Improved usability means the test could potentially be performed by untrained technicians and decisions can be made more quickly, saving time and cost.

“Anything that can provide testing in a social distancing environment is safer and easier to deploy and doesn’t require the clinical resources that are now required,” Kelly said.

Potential partners have approvals for their rapid test, and they would then conduct equivalency tests to show their test was as accurate, if not better run, on Atomo’s test. Then the diagnostic company would apply for emergency use authorizations with global regulators.

Validation of the device is expected to be completed within 10 to 12 weeks, and the products could be available to the public shortly after, depending on regulatory approvals.