Flu season is around the corner, typically affecting us between May and September. Just in time for that, Australian global molecular diagnostics company Genetic Signatures (ASX: GSS) is gearing up to launch its modified respiratory kit in the country.
The Company reported that the Therapeutic Goods Administration (TGA) has completed the review of its redesigned EasyScreen Respiratory Pathogen Detection Kit and included the updated device within the ARTG (Australian Register of Therapeutic Goods) to allow supply within Australia.
The updated kit has some minor modifications to the assay design, which improved the detection of Influenza B in samples with low virus concentrations. In December 2023, Genetic Signatures lodged an application to the TGA to cover the modifications made to the EasyScreen™ Respiratory Detection Kit.
CEO and Managing Director of Genetic Signatures, John Melki, said, “We are delighted to have secured TGA authorisation for sales of our modified EasyScreen™ Respiratory Detection Kit in time for the upcoming Australian influenza season. While this process did have a material impact on our sales revenue during the 2023 influenza season, we have maintained strong relationships with our customers throughout this time. We fully expect that the modified 3base™ assay for Influenza B will enable them to adopt our EasyScreen™ Respiratory Detection Kit in line with their usage in previous influenza seasons.”
Genetic Signatures is a specialist molecular diagnostics (MDx) company focused on developing and commercialising its proprietary platform technology, 3base. The Company designs and manufactures real-time Polymerase Chain Reaction (PCR) based products for the detection of infectious diseases under the EasyScreen™ brand (like COVID). It provides hospital and pathology laboratories with the ability to screen for a wide array of infectious pathogens with a high degree of specificity.
In August 2023, the Company informed the ASX of inconsistencies in detecting the influenza B virus when using the EasyScreen Respiratory Pathogen Detection Kit. It investigated and found that the season’s influenza B virus is not consistently detected in a small proportion of low viral concentration samples.
This affected its H1 FY24 performance. Its sales revenue fell by 65% from $10.4 million in H1 FY23 to just $3.6 million. The lower sales recorded in this period reflected the anticipated decline in molecular testing for SARS-CoV-2, combined with a reduction in respiratory revenue. Its gross profit also declined from $5.9 million to $1 million. Genetic Signatures reported an EBITDA loss of $11.3 million. It had $18.1 million in cash as of 31 December 2023 with no debt.
Having received a favourable outcome for its updated TGA application, the Company is ready to start selling this product to all its customers as the Australian influenza season commences.
The modifications have also been cleared for sale in the United Kingdom & the European Union. The Company has remained in consistent close contact with its existing customers and is fully expecting that revenue from its respiratory products will return to historical levels as a result of the TGA clearance for the redesigned product.
At the same time, the Company has also made its US bid. In September 2023, it submitted a 510(k) application to the FDA for regulatory clearance of the EasyScreen Gastrointestinal Parasite Detection Kit. Revenue from this is anticipated to kick off in H1 FY25.
Alinda is a Business Reporter for The Sentiment
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1 Comment
Shraddha13
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Replyhttps://www.360iresearch.com/library/intelligence/respiratory-monitoring-systems