RE: No News8 Mar 2024 19:49
The Company estimates that the total addressable UK market is up to £8.5 million per annum which is based on approximately 100,000 NICU admissions per annum and an estimated customer price per test of more than £80. The EU market is potentially another c. £46.8 million per annum, the U.S. market is c. £34 million and Rest of World markets around £13.8 million. Market estimates are based on end user pricing. The Directors believe that the UK and Europe presents an attractive market opportunity for the Company to target. The Company expects to pursue a distributor model alongside some investment in its own business development activities including an expanded commercial sales and marketing team to help drive initial adoption. A geographic expansion process is underway with targeted launch (outside the UK) expected in Spain, Saudi Arabia, Austria, France and Greece in H1 2023 with other countries to follow. Distributors have already been appointed in 8 countries. The Company is developing materials and undergoing activities to educate the market and drive product awareness.
Genedrive® CYP2C19-ID Kit ("CYP2C19")
The CYP2C19 ID Kit being developed will be used in conjunction with the Genedrive® System to provide a rapid, automated result of targeted CYP2C19 genotypes to inform clinicians on metaboliser status ahead of treatment strategies using drugs that are metabolised by Cytochrome P450 2C19 (CYP2C19). One example of the clinical utility of CYP2C19 metaboliser status in an urgent care setting would be rapid genotyping for the prescription of the anti-platelet therapy, clopidogrel. Clopidogrel is a pro-drug administered for the management of ischaemic strokes and requires conversion to an active form by the enzyme, CYP2C19. The combination of inherited CYP2C19 alleles determines the individual's metaboliser status. The CYP2C19 Kit screens for patients that should metabolize clopidogrel appropriately. Alternative drugs can be given to those that don't respond. CYP2C19 testing could generate more quality adjusted life-years for patients and lower costs compared with no testing.
The Company estimates that the total addressable UK market is up to £8.5 million per annum which is based on approximately 85,000 ischaemic strokes per annum. The EU market is potentially another c. £93.5 million per annum (c. 800,000 strokes per annum), the U.S. market is c. £67.6 million per annum (c. 700,000 strokes per annum) and rest of world markets c. £51.0 million per annum. The Company anticipates the customer price to be approximately £100 per test. The U.S. market has established reimbursement under Medicare (c. US$291). Market estimates are based on estimated end user pricing. NICE has included Genedrive's ® CYP2C19-ID Kit in a new Diagnostics Assessment Programme reviewing general applicability of CYP2C19 testing by any technique. The Company anticipates it could recommend genotyping is appropriate and cost effective.
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