Medical device company Atomo Diagnostics (ASX: AT1) has locked in purchase orders from Viatris Healthcare Pty Ltd amounting to approximately $970,000 for HIV Self-Tests. These tests, manufactured by Atomo under the Mylan brand, are designated for supply to several Low- and Middle-Income Countries (LMICs).

The orders are scheduled for production during the second half of FY24. Atomo deems the revenue generated from these orders as significant.

Atomo Diagnostics CEO, John Kelly, said, “We have seen growing demand during FY24 for the Atomo HIV Self-Test here in Australia as well as across branded versions supplied to international markets. Following significant increases in sales to Europe and in Australia, it is good to now see emergent demand across LMIC markets from our global health partner for HIV testing, Viatris.”  

Atomo Diagnostics, an Australian medical device company, specialises in providing unique, integrated rapid diagnostic test (RDT) devices to the global diagnostic market.

In the first half of FY24, the Company doubled its normalised revenue from <$1m to $1.92m. This increase suggests a rising demand for Atomo products and technology. Additionally, the normalised gross margin also saw a significant improvement compared to the first half of FY23, reaching 45%.

The revenue of $1.92m includes $1.52m from finished product sales and $407k from sales of OEM cassettes. The Company continues to receive orders supporting the outlook for the second half of FY24.

Atomo ended the half with a cash balance of $6.51m and being debt-free.

Atomo attributes the growth in its HIV business to two main trends: the increasing adoption of consumer self-tests through mainstream retail channels and the recognition by public health of the necessity to utilise self-tests to manage HIV.

Atomo’s contract with Newfoundland Diagnostics has led to the recent launch of its HIV test in Tesco supermarkets across the UK and in pharmacy stores across Germany, with over 400,000 tests ordered in the first year.

Its global health partner, Viatris, continues to promote the Mylan-branded version of the Atomo HIV Self-Test across Africa, making progress in several national tenders. Atomo’s status as the only HIV Self-Test manufacturer producing in Africa has attracted interest from leading global health funders.

Over the past two years, Atomo has facilitated innovative methods to access HIV testing in Australia, including vending machines in universities and adult premises, as well as a ‘free to user’ funded home delivery program. Anticipated formal adoption of HIV Self-Test as a pillar of Government policy into health budgets is expected to further drive demand for Atomo’s HIV Test in the coming years. 

In addition to HIV, Atomo is progressing with its blood-based pregnancy test, AtomoNOW, which provides earlier results and is simpler than traditional urine tests.

Continued growth in HIV business revenues and margins includes the extension of the Newfoundland agreement covering Europe for a further five years and the expansion of HIV Self-Tests into public health in Australia as policy opens up funded demand. Atomo’s entry into Africa and LMICs is further solidifying its growth ambitions.