Resonance closer to US approval
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A SUBMISSION to the US Food and Drug Administration for a novel diagnostic test for liver iron concentration holds the key to a lucrative market for Perth company Resonance Health.
A successful approval of the FDA 510(k) filing would allow Resonance subsidiary Inner Vision Biometrics to market its FerriScan test in the US where an estimated four million people suffer from iron overload diseases such as haemochromotosis and thalassaemia.
The 510 (k) submission follows the successful Australian Therapeutic Goods Administration listing of FerriScan, which has also given Resonance reciprocal access to European markets.
The company is now poised for an international roll out through collaborations with radiology groups in Australia and the UK.
Resonance has raised $1 million, through a placement, to fund the first stage of its FerriScan roll out.
The company has also gained $212,736 through a Biotechnology Innovation Fund grant to develop a new test called FibroScan. That test is aimed at the market for monitoring patients with advanced liver diseases such as hepatitis B and C and viral infections.