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 decisionmaking, 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.
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 AntibioticInduced Hearing Loss (AIHL).
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.
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.
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.
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.