Genetic Signatures builds on SARS technology
Shares in Genetic Signatures Limited (ASX:GSS) were up 50% at one stage on Monday morning as management announced that the company had supplemented its existing assays to specifically identify the 2019 novel strain of coronavirus (SARS-CoV-2), the virus that causes COVID-19.
Shares in the group started to gain traction in mid-March, increasing from about 90 cents to $1.10 before a Pause in Trading was executed on 26 March in order to for the shares to trade in an informed the market.
Further, the company has submitted a formal application for European CE-IVD registration for a new real time PCR (polymerase chain reaction) assay that does this.
Management has also submitted an application for inclusion on the ARTG (Australian Register of Therapeutic goods).
Confirmation of CE-IVD will allow for the continued marketing and supply throughout Europe and UK, as regulatory exemptions are for a defined period.
Licensed Australian laboratories are permitted to self-validate the tests to use the kits commercially.
The company sells both directly to end users and through distributors in Europe.
European data to support planned FDA emergency use authorisation
Since the beginning of the year when it became apparent the COVID-19 outbreak was a serious global problem, Genetic Signatures has directed resources to develop a SARS-CoV-2 specific test utilising its unique and proprietary 3base technology.
Data has been generated to support the submissions as required by the European IVDD (in vitro diagnostic directive) and TGA Medical Devices Regulation (ARGMD) to allow the product to be marketed as an in vitro diagnostic (IVD) in Australia and Europe.
The data submitted for European approval will also support the planned FDA EUA (Emergency Use Authorisation) regulatory application in the USA in the near term.
CE-IVD marking and inclusion on the ARTG creates a significant opportunity for Genetic Signatures as laboratories and governments seek fast and accurate tests.
The company has introduced laboratories in Europe and Australia for both the new test and its 3base technology and the group has manufacturing in place at its Sydney-based existing manufacturing facilities to meet anticipated initial high-volume orders.
As a global supplier of Covid-19 test kits, Genetic Signatures expects it will be classified as an essential service and, as such will not see its operations unduly impacted by increasingly strict lockdowns.