It may be a case of missing the boat for life science company AnteoTech (ASX: ADO) which has been advised by Australian regulators that their submission to have their Rapid Diagnostic Test approved for commercialisation has not met the regulatory requirements, despite a glaring shortage of Rapid Antigen Tests in the community.
Additional information was first sought by the Therapeutic Goods Administration from AnteoTech on 15 December 2021. However, the supplementary information did not fulfill the TGA’s guidelines. This will result in further delays for AnteoTech to be able to market their EuGeni Reader and SARS CoV- 2 Ag Rapid Diagnostic Test.
While the TGA has not rejected the submission, the regulator has requested further trial data with the existing data collected not meeting the stringent requirements for medical products to be sold to the Australian public.
New trials are planned to be undertaken at the Department of Infectious Diseases, Clinical Research Unit at the Alfred Hospital and Burnet Diagnostic Initiative (BDI) at the Burnet Institute in Melbourne. However, with the current Omicron strain of COVID-19 rampant across Melbourne, AnteoTech has flagged delays in the trials due to staffing strains on the healthcare system.
Since confirming their Rapid Diagnostic Test submission was being reviewed by the TGA, ADO shares had climbed from $0.17 in December 2021 to reach a high of $0.415 a month later on approval speculation which would have been a major revenue driver for AnteoTech.
Following news of the latest TGA submission setback, ADO shares fell back to $0.205 in early morning trade,a 35% drop on their previous $0.315 close.
Alfred Chan is an Analyst at Emerald Financial, specialising in ASX-listed small cap companies.
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