Swift departure, and replacement, of genedrive CEO

James Cheek, Chief Executive of Manchester molecular testing business, genedrive, has left the company with immediate effect and by mutual agreement, less than a year after joining.

The company, which makes medical testing equipment, issued an announcement to the stock exchange this morning (August 6), detailing his departure, and informing shareholders that he has been succeeded as CEO by Dr Gino Miele, currently Chief Scientific Officer, who has been with the company since 2011, serving as R&D director and, since September 2023, as CSO and an executive board director.

Prior to joining the company Miele served as an Associate Director for clinical translational genomics at Wyeth and Pfizer.

Dr Miele has been a key driver in the development of the genedrive instrumentation and products, positioning the company at the forefront of pharmacogenomic testing in emergency healthcare settings and with the wider team has facilitated regulatory approval processes for the products throughout the UK, Europe and the Middle East.

The company said he was instrumental in the NICE (National Institute for Health and Care Excellence) approval processes for both the Genedrive MT-RNR1 ID Kit and the Genedrive CYP2C19 ID Kit, securing the group’s clinical trial agreement in the US, the recent FDA breakthrough device designation, and together with the genedrive commercial team is actively involved in generating a growing list of revenue opportunities in the UK and more widely.

Dr Ian Gilham, genedrive Chairman, said: “Gino has an unparallelled knowledge and understanding of the company, products and commercial strategies.

“I have every confidence that the leadership team, headed by Gino and strongly supported by our Chief Financial Officer, Russ Shaw, will lead genedrive to a successful future. I would like to thank James for his contributions at genedrive and, on behalf of the board, wish him well for the future.”

James Cheek was appointed a director and Chief Executive of genedrive on September 11, 2023, bringing extensive commercial and operational experience at a senior level through a successful career with established diagnostic companies such as Cepheid, Beckman Coulter, and Roche Diagnostics.

He also served as an executive board member of the British In Vitro Diagnostics Association (BIVDA) and represented the trade body as part of the NHS Supplier Board.

On his appointment, genedrive said: “The board believes James’s experience, especially his extensive involvement in selling into the NHS, will be valuable as the company expands its commercial footprint and opportunities within the UK and more widely.”

Last month genedrive announced that NICE had recommended that CYP2C19 genotyping should be used after a stroke and that the Genedrive CYP2C19-ID test should be used as the test of choice for point-of-care strategies.

It said the company would now actively pursue commercialisation in the UK and Middle Eastern countries where device registration is enabled by UKCA certification, and was fully prepared to supply and meet the anticipated demand.

Receipt of CE-IVD certification, in addition to UKCA certification, would enable the company to penetrate markets which it estimates are worth in excess of £100m per annum.

The CYP2C19-ID test uses a single, non-invasive cheek swab sample, and rapidly identifies six important genetic variants of the CYP2C19 gene, five of which are instrumental in the loss of metabolism function. The system automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan.

James Cheek said at the time: “This represents a key milestone in our commercialisation plans for the product, and further solidifies our business strategy of leading provision of cost effective solutions for pharmacogenetics in time critical emergency healthcare situations.

“We are proud to be at the forefront of the emergence of near-patient genetic testing in emergency healthcare to facilitate optimal personalised therapeutic choices and ultimately improve patient outcomes.”