Hepatitis C market frustrations

genedrive plc (GDR) is a commercial-stage company focused on point-of-care molecular diagnostics. Its Genedrive® molecular diagnostic platform is at the forefront of this technology, offering a rapid, low-cost, simple-to-use device with high sensitivity and specificity in the diagnosis of infectious diseases. Rapid analysis of patient samples greatly aids clinical and public health decision-making, particularly in remote areas of developing countries. However, despite the clear utility of the HCV-ID kit for diagnosis of hepatitis C virus (HCV) infections, the frustrating nature of the HCV market has led to little HCV-ID sales growth in 2019.

• Strategy: Now that the Genedrive technology platform has received CE marking, management has completely re-focused the company onto the commercialisation pathway for gene-based diagnostics in Hepatitis C, tuberculosis, Bio-threats, and Antibiotic-Induced Hearing Loss (AIHL), divesting its Services unit in June 2018.
• Trading update: Group sales grew 25.6% to £2.4m (£1.9m) in the 12 months to June, the first full year without the services business. The mix of group sales was considerably more balanced than the prior period, with product sales of ca.£1.0m (£0.1m), which included ca.£0.9m from the US Department of Defense (DoD).
• HCV product: Management has been very open on the difficulties encountered in commercialisation of the HCV-ID kit. The process for obtaining in-country registrations has been slower than anticipated, and uptake in registered countries has been frustrated by low demand due to a lack of funding for HCV drugs.
• Risks: Genedrive platform technology has been validated by the CE marking of its assay for detection of HCV infection and by recurrent work from the US DoD. The main risks are commercial, given that it often takes time for new technologies to be adopted. Partnering with major global and local experts reduces this risk.
• Investment summary: Genedrive technology ticks all the boxes of an ‘ideal’ in vitro diagnostic that satisfies the need for powerful molecular diagnostics at the point of care/need. The hepatitis C market is a very large global opportunity, and should market factors improve, the HCV-ID test has excellent potential. With strong partners being signed for different countries, such as the NHS (UK), and several product lines in development, GDR has a solid growth strategy in place.