Acceleration of news flow expected

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. Rapid analysis of samples aids real-time decision-making, whether in clinical, public health or biothreat applications. GDR is developing a portfolio of assays for the Genedrive device. Its hepatitis C virus (HCV) and pathogen detection assays are already on the market, and products for tuberculosis (TB) and screening against adverse reactions to antibiotics are in development.

• 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, TB, bio-threats and Antibiotic-Induced Hearing Loss (AIHL).
• 2019 results: Reported group sales increased 21.9% to £2.4m (£1.9m) in the 12 months to June 2019. Product sales of £0.9m from the US Department of Defense (DoD) and £0.5m from customers in Europe contributed to a more balanced income, the remainder being grant income.
• Interesting period: Management has been very open on the frustrations encountered in developing HCV markets. However, GDR is in an interesting transition, with HCV-ID kit “real-world” data being collected in global clinical settings and a study under way for AIHL in the UK.
• Risks: The Genedrive platform has been validated by CE marking of the HCV-ID kit, repeat orders from the US DoD, and funding from Innovate UK and the NIHR. The key risks are commercialisation in undeveloped global health markets and funding for anti-viral or anti-microbial drugs. Partnering tempers these risks.
• 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 large global opportunity – should market factors improve, the HCV-ID test has excellent potential. With strong partners, e.g. the NHS, being signed in both developed and developing markets, and several product lines in development, GDR has a solid growth strategy.