Hepatitis C point-of-care diagnostic launched

genedrive plc is a commercial-stage company focused on point-of-care/need molecular diagnostics and biomarkers. Its Genedrive® molecular diagnostic testing platform is at the forefront of this technology, offering a rapid, low-cost, simpleto-use device with high sensitivity and specificity in infectious disease diagnosis. Rapid analysis of patient samples greatly aids clinical and public health decision- making, with field testing particularly important in emerging markets. Hepatitis C diagnosis is a multi-million-dollar market opportunity; the company launched its Genedrive HCV ID Kit in 1H’18 at the IFCC World Lab conference in South Africa.

• Strategy: Now that the Genedrive technology platform has received CE Mark, the new management team has completely re-focused the company onto the commercialisation pathway for diagnosis of infectious diseases, signing two important commercial agreements with Sysmex, a major global player.
• Trading statement: Group sales in 1H’18 were marginally ahead of forecasts, at £2.6m, down from £2.88m in 1H’17, representing a fall of 11%. The diagnostics division was slightly above forecasts, offsetting a weak performance in the services business. Cash at 31st December was also ca.£0.1m above forecasts.
• Genedrive: Distribution partner, Sysmex, has completed successfully the first field study in Africa of the Genedrive® Hepatitis C (HCV) ID Kit at an independent testing laboratory in Johannesburg. In 130 clinical samples from a number of countries, the kit demonstrated sensitivity and specificity of 100% compared with the Abbott M2000 HCV Real-time assay as a reference.
• Risks: The platform technology has been de-risked through the receipt of CE Mark for its first two assays – hepatitis C and tuberculosis. The main risk is commercial, given that it often takes time for new technologies to be adopted. However, partnering with a major global player significantly reduces this risk.
• Investment summary: Genedrive technology ticks all the boxes described for an ‘ideal’ in vitro diagnostic that satisfies the need for powerful molecular diagnostics outside the hospital setting. The hepatitis C market is a global opportunity, very large even in developing countries. With a strong commercial partner now in place, early evidence of sales traction will highlight the valuation anomaly.