Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company") 

Initial orders of the Genedrive MT-RNR1 Products for new sites in the UK

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, is pleased to announce that initial orders have been received for the Genedrive MT-RNR1 products from a further five UK hospitals in the Greater Manchester region as they progress towards the sustained deployment in clinical practice in these Neonatal Intensive Care Units ("NICU").

The total value of the orders is in excess of £100,000 and the NICUs of the five hospitals, The Royal Oldham Hospital, Stepping Hill Hospital, Royal Bolton Hospital, Royal Albert Edward Infirmary and Tameside General Hospital admit approximately 1,900 babies per year. These additional sites more than double the number of NICUs in the UK using the test in routine practice.

The Genedrive® MT-RNR1 ID Kit is a simple non-invasive test that can identify babies in NICU with an MT-RNR1 genetic variant rapidly in approximately 26 minutes who may be at high risk of hearing loss if given aminoglycoside antibiotics, enabling rapid clinical decisions on antibiotic prescribing in neonatal emergency care, and the avoidance of administration of aminoglycosides in those individuals in which the genetic variant is present.

The Genedrive® MT-RNR1 test received conditional recommendation from the UK's National Institute for Health and Care Excellence ("NICE") in March 2023, enabling its use in the NHS whilst further evidence is generated. Plans for generating the required further evidence are underway, with the goal of enabling transition from conditional to full recommendation by NICE, which in turn is expected to facilitate funding for the test at a national level.

James Cheek, CEO of genedrive plc, said: "I am delighted to see the positive effects of our direct to customer commercialisation strategy in the UK, with further NHS engagement and uptake for bringing this vital test which has the potential to avoid profound, irreversible hearing loss in babies in neonatal care units into day-to-day use in neonatal emergency care. Our expectation is that more NHS trusts will adopt this simple to use point of care genetic test in the coming months and we continue to grow our opportunities overseas."

Ajit Mahaveer, Clinical Lead for the Northwest Neonatal Operational Delivery Network (NWNODN), said: "The implementation of the Genedrive MT-RNR1 test across all neonatal sites in Greater Manchester represents a significant advancement in preventing hearing loss in infants and enabling rapid genetic testing at the bedside". 

Jonathan Massey, Programme Director for Academia at Health Innovation Manchester said: "Health Innovation Manchester is pleased to continue to work with genedrive and our academic and health partners to ensure the sustained deployment of this innovative test across the whole of Greater Manchester". 

The Company also confirms that the following Directors have completed their applications to participate via the REX Retail Offer or the Open Offer in the Fundraising that was announced on 9 May 2024. The £ sterling amount of the applications are as follows: Russ Shaw £25,500, Gino Miele £15,000, Ian Gilham £10,000 and Chris Yates £3,000. As previously announced, on 9 May 2024 James Cheek and Tom Lindsay both acquired Firm Placing Shares to the value of c.£10,000.

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About genedrive plc (http://www.genedriveplc.com). genedrive plc is a pharmacogenetic testing company developing and commercialising a low cost, rapid, versatile and simple to use point of need pharmacogenetic platform for the diagnosis of genetic variants. This helps clinicians to quickly access key genetic information that will aid them make the right choices over the right medicine or dosage to use for an effective treatment, particularly important in time-critical emergency care healthcare paradigms. Based in the UK, the Company is at the forefront of Point of Care pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on how your individual genetics impact a medicines ability to work for you. Therefore, by using pharmacogenetics, medicine choices can be personalised, made safer and more effective. The Company has launched its two flagship products, the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit, both developed and validated in collaboration with NHS partners and deployed on its point of care thermocycler platform. Both tests are single-use disposable cartridges which are ambient temperature stable, circumventing the requirement for cold chain logistics. The Directors believe the Genedrive® MT-RNR1 ID Kit is a worlds-first and allows clinicians to make a decision on antibiotic use in neonatal intensive care units within 26 minutes, ensuring vital care is delivered, avoiding adverse effects potentially otherwise encountered and with no negative impact on the patient care pathway. Its CYP2C19 ID Kit which has no comparably positioned competitor currently allows clinicians to make a decision on the use of Clopidogrel in stroke patients in 70 minutes, ensuring that patients who are unlikely to benefit from or suffer adverse effects from Clopidogrel receive an alternative antiplatelet therapeutic in a timely manner, ultimately improving outcomes. Both tests have undergone review by the National Institute for Health and Care Clinical Excellence ("NICE") and have been recommended for use in the UK NHS. 

The Company has a clear commercial strategy focused on accelerating growth through maximising in-market sales, geographic and portfolio expansion and strategic M&A, and operates out of its facilities in Manchester.