What the company does
Genedrive has developed and is now commercialising a low-cost, rapid, versatile and simple-to-use diagnostic.
The device of the same name has a broad range of applications.
However, its HCV-ID variant, for detecting hepatitis-c, has received EU regulatory sign-off in the form of CE Certification and has been launched in Africa and the Asia Pacific region. In development is a model for tuberculosis.
In November, the company's RNR1 test for AIHL or Antibiotic Induced Hearing received a European CE mark.
So why is this interesting?
Well, the system is able to rapidly process the biologic information from plasma, sputum and buccal swabs. It is easy to use, provides unambiguous results, so doesn’t require specialist knowledge or data interpretation. The company reckons the hand-held Genedrive system is ideal for “low throughput de-centralised labs”.
Financial Position and current trading
Revenues for the 12 months to June 30 rose almost 22% to £2.36mln.
A total of £900,000 orders for pathogen kit were received from the US Department of Defense with more to come.
As is common for a company it this formative stage of its commercial progress, genedrive was loss-making. The operating loss was just over £4mln.
More importantly, it had £3.9mln of cash as at September 26 after a successful £6mln fundraiser earlier in the year.
In October, Genedrive received approval from the NHS Health Research Authority to start testing its Antibiotic Induced Hearing (AIHL) test in hospital trials in Manchester and Liverpool.
The AIHL test identifies a condition that occurs in one in 500 people and can result in profound deafness if a baby with the genotype is given the antibiotic gentamicin.
Every year 90,000 babies in the UK are treated for bacterial infections with gentamicin.
In November, the test RNR1 received CE accreditation enabling it to be sold across Europe.
What the boss says: David Budd, chief executive
"CE marking of our RNR1 test allows for the next phase, with implementation evaluation by our NHS partners in Manchester and Liverpool.
“At the same time, we will look to the opportunities outside of the UK where CE marking gives us market entry."
- AIHL test will be trialled in Manchester and Liverpool for the next 6-8 months
- The1,000 patient trial will start in November
- Genedrive has won its first order from the US Department of Defense (DoD) and it expects more work from the Americans
- The HCV ID kit is under review by the World Health Organisation for ‘pre-qualified status’
- Registrations of the hepatitis device are now running at 12 countries
- Genedrive’s development of an antibiotic-induced hearing loss test for babies with the NHS is ahead of schedule