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”.
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.
How it is doing
In September the coronavirus testing kit was approved by the South African health products regulator.
The assay was also verified to work with the RNA extraction technology of its collaboration partner.
Initial testing took place using Beckman Coulter Life Sciences’ chemistry on respiratory swabs in conjunction with genedrive’s 96 SARS-CoV-2 equipment.
This indicated the Beckman product was suitable for use in the genedrive testing workflow. The tie-up with Beckman included genedrive validating the analytical parameters of the combined companies’ offerings.
Having established performance, the plan going forward is then to introduce the overall solution in stages, beginning with swab-based claims before transitioning to saliva. It was part of a collaboration with the life sciences company.
The plan is to fully automate the entire laboratory polymerase chain reaction (PCR) testing process for COVID-19. The two companies are working to combine and validate the Genedrive 96 SARS-CoV-2 Kit on the Biomek i7 automated workstation with saliva samples extracted using Beckman Coulter’s RNAdvance viral extraction chemistry.
What the boss says: David Budd, chief executive
“This is an important milestone in the commercialisation of our COVID-19 kit in the region. South Africa is a key territory for our distributors and this approval will now provide an acceleration of commercial sales activity in the area.”
- Collaboration with Beckman Coulter Life Sciences
- Second test to be 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 GBP1.5mln 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 GBP75mln on an annualised basis, could theoretically generate a gross margin of 60-80%