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Genetic Signatures (ASX:GSS) shares were down -1.45% to 68cps on Monday, even as the company reported a greenlight from the TGA to sell its flu test devices on the market.
At the same time, the Health Care sector is up +1.27% – suggesting that the stock isn’t just being dragged down by bigger boats.
GSS’s ‘EasyScreen’ kit ultimately allows one to quickly check for the flu. The TGA required, at first, the company to make some modifications.
Those alterations were minor, GSS reports, and relate to the ‘assay design’ of the device. Influenza B detections were thus more effective following alterations, the company reported on Monday.
The TGA has strict guidelines not only for drugs in Australia but also for medical devices which must, for instance, be free of cancer-causing materials (quite straight forward) and also harmonise with overhead UN frameworks on human ethical research (less straight forward.)
TGA reps must also inspect manufacturing facilities and sponsors are legally obliged to monitor social media for any users complaining of issues related to any device.
GSS cleared these hurdles, and on Monday, reported it had received “favourable” treatment at the TGA.
The stock also noted flu season is upon us. Further, the modified test kits are also greenlit for sale in the UK and EU.
GSS says revenue will get back to normal, now that modification issues have been tweaked.
Company chief John Melki described himself as “delighted” – and yet, shares are actually down.
GSS last traded at 68c.
