PERTH: AnteoTech Ltd has achieved ISO-13485 certification allowing the company to participate in the Point of Care (PoC) market as a legal manufacturer of medical devices.
The certification completes a long program of work and associated independent audits to establish systems and processes associated with development and regulatory approval of lateral flow assays.
This new approved competency is currently in use for the development and regulatory approval of AnteoTech’s COVID-19/Flu A/Flu B High Sensitivity Multiplex Rapid Test. AnteoTech is now an approved assay developer. The return characteristics at the assay development end of the PoC value chain are fundamentally different to those at the raw material end where AnteoTech has focused up until now.
Assay development adds a significant new return potential and complimentary business element to AnteoTech’s existing raw material supply operations. In achieving ISO-13485 certification, AnteoTech’s progression along the PoC value chain to assay developer is complete.
AnteoTech will leverage this position by establishing clear and strong differentiating market positions in order to maximise returns to the Company.
AnteoTech’s CEO Derek Thomson commented:“ISO-13485 certification is the final element completing AnteoTech’s progression to a position that will allow us to launch our own assays into the market and we are delighted to have achieved this key milestone. The Life Science business now has a platform from which to leverage new revenue and growth and we are working very hard to exploit this opportunity starting with developing and owning a highly sensitive COVID-19 Antigen Rapid Test which we aim to be our first assay product in the market.”
“Our Life Sciences team has worked extremely hard to achieve this certification and I would like to thank them all for their commitment to this goal. In particular I commend the work of our ISO-13485 project leader, Vanessa Worsfold, for her professional guidance, in depth knowledge of ISO-13485 and team leadership to achieve this result.”
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