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Ann: TGA registration for superbug detection kits, page-13

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  1. 122 Posts.
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    The GSS technology is basically a multiplex PCR test. PCR (polymerase chain reaction) was invented 30 yrs ago and is very widely used. Commercial multiplex PCR tests have only recently been adopted widely in diagnostic medicine and there are many others besides GSS ones. The GSS technology is distinct from others in its '3-base' technology which, should make it superior at detecting multiple targets reliably. Earlier PCR tests only detected one target at a time. The '3-base' feature is a relatively minor modification to the usual PCR, not costly to add and is where the GSS innovation lies.
    The reagents in a PCR test are relatively inexpensive, with production readily scaleable. There are many companies making profits already from PCR tests, although is relatively recent that a shift to the 'multiplex' ones has happened ie detect multiple targets at once instead of just one. Examples of molecular diagnostic companies using multiplex PCR are Cepheid, Biofire, Seegene.
    I actually don't think the challenges for GSS will be in scaling up, more how it will compete with other multiplex PCR tests. There is a sound theoretical basis for the advantage conferred by 3-base feature in multiplex PCR, but even so it remains to be seen how it fares. No other companies use the 3-base method and we have a patent on it. That said, I am very encouraged by the fact GSS customers seem to stick with the technology, once they have tried it, suggesting it does give superior results. The recent growth in sales revenue is also very encouraging, as is the announcement that a US lab has started using ASR's.
    The demand for multiplex PCR tests is huge and greatly increasing as its replacing traditional microbiological methods. Even if we gain a relatively small proportion of the market, it will be huge compared with where we are now.
    Also, multiplex PCR is very suited to 'screening' tests, ie done to rule out the possibility people have a disease, instead of using it only later down the track when they get sick. This means the tests are used in high volumes and so the market is very large.
    The summary of the report below is free and relevant to GSS. The paragraph 'Technology and regional insights' talks about multiplex PCR in particular.
    www.grandviewresearch.com/industry-analysis/molecular-diagnostics-market
 
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