US FDA pre-submission for Genedrive MT-RNR1 kit21 Oct 2022 13:29
RNS Number : 7594B
"The US is a particularly attractive market for this unique test given the potential to save hundreds of individuals from life-long deafness and reduce litigation costs relating to the unwanted side effects from antibiotic use on those carrying the gene variant. Either an FDA 510(k) clearance or the granting of a De Novo request is required to allow us to market this test in the US. Ultimately, we feel that the US market is potentially the most attractive market given its size, birth rates, use of diagnostic testing and reimbursement structure."
Do we know the reimbursement structure GDR will likely receive for testing in the UK using an estimated 90,000 babies treated in the UK per year according to Bill Newman, clinical geneticist and professor at the University of Manchester?
And does anyone have any ballpark reimbursement figures using; 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely?