Regulatory hurdle leaped: hearing loss assay

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, with its hepatitis C virus (HCV) and pathogen detection assays already on the market. Its assay for screening against adverse reactions to antibiotics obtained CE marking this week, allowing progression to the next stage towards commercialisation: an NHS implementation study.

• 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 (TB),
  bio-threats and Antibiotic-Induced Hearing Loss (AIHL).
• CE marking: genedrive’s products require CE marking before they can be sold in the EEA. Therefore, obtaining CE marking for the AIHL assay – the Genedrive® MT-RNR1 ID kit – is a necessary hurdle to allow entry into the UK and other European markets, on track to launch in 2020.
• Large market potential: Peak sales in the UK could reach £3.6m if the MT-RNR1 assay is adopted for screening of all babies prior to treatment with gentamicin antibiotics (ca.90k per annum). In the UK alone, this could prevent 180 cases of AIHL each year, saving children from bilateral and irreversible hearing loss.
• 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.