Newly-listed medical device company Atomo Diagnostics (ASX: AT1) has signed a binding agreement with US-based Access Bio Inc which will allow for the supply of Atomo’s Galileo rapid diagnostic test (RDT) device for use with Access’ rapid test strips for the detection of COVID-19 antibodies.
Access currently offers a standard COVID-19 rapid blood-based test using a lancet device to generate a blood sample from a patient’s skin and a separate manual pipette to collect and deliver blood to the test strip.
This test kit format received an Emergency Use Authorisation (EUA) by the US Food & Drug Administration (FDA) on 24 July 2020.
By contrast, these two steps – lancing and collecting – are integrated in products which utilise Atomo’s RDT device.
Finished products being commercialised under this agreement include a COVID-19 rapid antibody test for professional use and a COVID-19 rapid antibody test for self-test use.
Once relevant authorisations and approvals have been obtained, the kit will be co-branded by Access and Atomo for launch in the US, Canada and Mexico.
Access will be the listed manufacturer and will retain non-exclusive rights to sell the products to regions excluding Europe, Australia and New Zealand and South East Asia where Atomo already has contractual arrangements in place.
Under the agreement, Access will be obliged to sell a minimum two million RDTs and test strips by September 2021, after which the agreement will roll over for another 12 month period with the same obligations and thresholds.
If the initial threshold is not achieved by September 2021, Access will make a payment to Atomo for the number of units short of two million and its regional sales rights will automatically revert to non-exclusive.
Atomo will receive a percentage of the gross revenue from all product sales in consideration for supplying the Galileo cassettes to Access.
Atomo managing director John Kelly said the partnership between the two companies was timely.
“Access has strong ties to US markets and [it] is a natural fit for the next phase of our expansion in the COVID-19 market,” he said.
“Blood-based rapid diagnostic testing is an essential component of the global fight against COVID-19 and given the increasing urgency of the situation in the US, we are delighted to be able to play our part in attempting to defeat this pandemic.”
Mr Kelly said Atomo was mid-way through ramping up its manufacturing capacity to meet its volume obligations under the Access agreement and cater to global demand for its products.
The first phase of the implemented capacity upgrade will be completed this quarter with total monthly device capacity increasing from approximately 250,000 units per month to 500,000 units per month.
The company plans to be producing more than one million units per month by the end of the year.
“We remain focused on increasing manufacturing capacity over the coming 12 months, with the first step-up in additional production volume anticipated to be validated and available in August,” he said.
“This will support the increasing demand we are seeing for our innovative rapid test solutions globally as we continue to rollout out our products in HIV and COVID-19 markets.”
In April, Atomo became the first company to list on the ASX since the end of February and the first ever company to hold a virtual ASX listing ceremony.