The Anteotech Ltd (ASX: ADO) share price is falling today after the healthcare company announced it has another hoop to jump through regarding its COVID-19 rapid antigen tests (RATs).
At the time of writing, the AnteoTech share price is down 8.5% to 22 cents.
Let's take a look at what's happening…
New requirement for AnteoTech RAT tests
AnteoTech is seeking approval from the Therapeutic Goods Administration (TGA) to register its RAT test for COVID-19.
The RAT incorporates AnteoTech's existing EuGeni Reader technology with a SARS CoV-2 Ag Rapid Diagnostic Test (RDT).
If successful, the approval would allow AnteoTech to market and commercialise its RAT for Australian use. There is also the potential for expansion into larger markets.
The company prides its EuGeni Reader as being a "fast, accurate and compact solution for rapid point-of-care testing". It has been adapted to create the RAT and results so far indicate "a 97.3% sensitivity" rate.
However, AnteoTech has not yet been successful.
The healthcare company made the initial submission back in September. Today marks the third registration update released to shareholders. In it, the TGA asks for more clinical data from COVID-19 patients using the device.
In order to proceed with the application, further clinical trials will be conducted in Europe and Australia. Once the required data is obtained, AnteoTech intends to compile a new submission to the TGA.
Comment from management
AnteoTech said these new trials will demonstrate the product's performance "relating to new variants of concern listed by the World Health Organisation (WHO), lower limit of detection and other performance measures from a vaccinated population".
AnteoTech CEO Derek Thomson said:
We have worked directly with the TGA to understand the most efficient method of supplying the data they now require and our highest priority is to generate this data as quickly as possible.
These further trials will provide AnteoTech with the opportunity to gain additional clinical data which will enhance the growing body of evidence for performance of both the EuGeni Reader and the RDT.
AnteoTech share price snapshot
The AnteoTech share price started to pick up in the middle of 2020, right in the midst of the pandemic. Beforehand, its shares were trading around 1 cent each.
Shares reached a new high in April last year, hitting 44 cents each.
The AnteoTech share price has been fluctuating in 2022. The highlight has been a 30% gain in the first week of February.
The healthcare company has a market capitalisation of $426 million and 1.97 billion shares on issue.
