The Brisbane-based company said a clinical trial of its Covid-19 RAT kit has been stalled by the Omicron strain and its impact on the health system’s staffing. It also revealed the approval to distribute its EuGeni Covid-19 test kit had been hit with another request for more information by the Therapeutic Drugs Administration.
Investors ran for the exits at the opening bell wiping $177 million from the market value of the company.
The company already markets its test kit in Europe and Asia and manufactures in Spain. It has been seeking approval from the Therapeutic Drug Administration since September last year to sell its product in Australia. It has been asked twice for more information.
“The most recent request primarily relates to the collation of additional clinical data, together with others aspects of information,” AnteoTech told the ASX this morning.
However, the company, headed by Derek Thomson, said the TGA was working collaboratively with it to work through the specifics of the request and how to best address the clinical data requirements.
Anteotech was also conducting a clinical trial at the Alfred Hospital in Melbourne to gather more data on its test kit. It expected the trial would provide any further data needed by the TGA.
“However, the current Omicron wave and staffing strain on the health system, including clinical research organisations, is currently impacting the timeline of the study,” it said.
A TGA request in December related to the test kits ability to detect Covid-19 variants.
A clinical trial in India of its product was also scrapped last year when Covid-19 devastated that country.
AnteoTech claims that the EuGeni reader is powerful enough to detect COVID-19 before symptoms emerge.
It has previously estimated the global market for RATs was about $5 billion and has plans to enter the US market this year.
A clinical trial of the product was done by the Doherty Institute in March last year.
Anteotech’s fall was not mirrored by the rest of the market which rebounded after two days of heavy losses.
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