- Genetic Signatures (GSS) completes recruitment for its 3base EasyScreen enteric protozoan diagnostic kit clinical trial in the US
- The EasyScreen enteric protozoan diagnostic kit uses GSS’ 3base technology to detect up to eight species of gastrointestinal parasites which is more than traditional methods
- The recruitment is an essential step towards supporting its application to the FDA, with submission of a 510(k) application planned during the fourth quarter of CY2022
- Once cleared, the company will market this syndromic PCR test to the US market
- Shares in Genetic Signatures are down 2.65 per cent, trading at $1.10 at market close
Molecular diagnostics company Genetic Signatures (GSS) has completed recruitment for its 3base EasyScreen enteric protozoan diagnostic kit clinical trial in the US.
The company’s EasyScreen enteric protozoan diagnostic kit uses its proprietary 3base technology to analyse the genetic profiles of protozoan pathogens.
This technology allows rapid and accurate detection of up to eight species of clinically
relevant gastrointestinal parasites which is more than traditional methods. Results are available within hours as compared to days or weeks for culture-based methods.
The recruitment is an essential step towards supporting its application to the Food and Drug Administration (FDA).
Once cleared, the company will market this syndromic PCR test to the US market.
CEO Dr John Melki called the milestone “significant” especially after facing considerable delays due to COVID-19.
“Our enteric product range has attracted a great deal of commercial attention, reflecting the breadth of targets able to be identified in a single test.
“The US is a significant opportunity for our Enteric Protozoan Kit with an estimated total
addressable market of 5.5 million tests per annum.
“We are targeting to gain 40 per cent of the market within five years while also providing the introduction for utilisation of our other 3base EasyScreen molecular diagnostic kits.”
To support the company’s 510(k) application, Genetic needs to provide data from 1500 clinical samples collected across three different sites in the US.
Once completed, Genetic anticipates an FDA 510(k) application to be submitted during the fourth quarter of 2022 after which the FDA will review the application and respond with a decision within 90 days from submission.
Shares in Genetic Signatures were down 2.65 per cent, trading at $1.10 at market close.