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. It is also approved by the World Health Organisation.

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”.


How it is doing

Genedrive has leveraged its 20-year experience in the sector to create two coronavirus tests.

The first one, which has received the CE marking with sales expected for June, allows laboratories to analyse assays from 100 patients in 90 minutes.

The second test, expected to be ready for later on this year, is for use outside hospital settings, such as care homes.

The projects have been well received by the market, with the share price zooming 1,500% between March and June.

The firm also partnered with supplier of medical technology Inspiration Healthcare Group PLC (LON:IHC) for its test to detect hearing loss in babies.

Under the agreement, Inspiration Healthcare will roll out the test in the UK and Ireland, with plans to expand to its 50-strong network of neonatal-focused distributors across the world.


What the boss says: David Budd, chief executive

“From concept to CE marking, we managed to bring a product in eight weeks, a lot of people don’t recognise that normally these processes take a year or a year and a half. There has been an incredible amount of work from everyone.”

“It’s really been great to see the importance that diagnostics companies play in medicine recognised. We even have the World Health Organisation saying test, test, test and that is very gratifying from an industry standpoint.”

“I have worked in diagnostics for over 20 years, it always feels a little bit like the cousin to big brother pharma, but we know that 70% of all medical procedures are founded on having a diagnostic test.”




Inflexion points 

  • Initial sales from first coronavirus test
  • Second test launched later in the year
  • Commercialisation of baby deafness test


What the broker says

House broker finnCap said in May that the coronavirus test could potentially generate revenues of up to around £1.5mln per week.

This is based on partner Cytiva’s scalable manufacturing method, which is capable of producing 10,000 polymerase chain reaction (PCR) beads per hour.

Such revenues, which amount to £75mln on an annualised basis, could theoretically generate a gross margin of 60-80%