(MENAFN - ProactiveInvestors - Australia) Resonance Health's (ASX: RHT) FerriScan technology has been authorised by the U.S. Food and Drug Administration to be marketed as an imaging companion diagnostic device for use of Exjade in patients with non-transfusion-dependent thalassemia (NTDT).
Exjade is a drug marketed by Novartis to remove excess iron in patients with genetic blood disorders.
The FDA said in a statement "the FerriScan device is a non-invasive test that helps physicians to select appropriate patients [with NTDT] for Exjade therapy as well as monitor their response to the drug."
It is known that over three quarters of a million people worldwide have non-transfusion-dependent thalassemia (NTDT) and many patients are not diagnosed until they develop serious symptoms which begin to appear as early as age 10.
Most patients with NTDT are of South and Southeast Asian, Mediterranean or Middle Eastern origin, with immigration broadening the global presence of this condition.
FerriScan has been used extensively in the clinical trials of pharmaceutical companies developing drugs for chronic iron overload since 2004.
This FDA announcement of FerriScan as a companion diagnostic for the safe and effective use of a drug recognises its importance in the clinical management of patients outside of clinical trials.
FerriScan is currently used in many hospitals around the world and this authorisation by the FDA will assist in expanding the use of FerriScan in the identification and management of patients with iron overload.
It will also assist in the Company's efforts to gain insurance coverage for FerriScan within the US, enabling more patients to access FerriScan.
The company also said it does not have details concerning how often a patient with NTDT and prescribed Exjade will require a measurement of their liver iron concentration.