Proactive Investors - Run By Investors For Investors
Why invest in GDR?

Molecular diagnostics specialist Genedrive has hepatitis landmark in sight

Regulatory sign-off will fire the starting pistol on the commercial launch in Europe
Molecular diagnostics specialist Genedrive has hepatitis landmark in sight
The company has developed a quick and cheap test for Hepatitis-C

Genedrive PLC (LON:GDR) is nearing a landmark for its breakthrough rapid diagnostic for Hepatitis-C with the AIM-listed group ready to submit its breakthrough for regulatory approval.

The receipt of CE IVD certification under the EU Medical Devices Directive would green-light the commercialisation of the product in the European Union.

The application for CE Marking will be supported by the recent “excellent” performance data from a clinical validation study carried out at Institut Pasteur, in Paris, and Queen's Medical Centre, Nottingham.

Simple and speedy

Genedrive’s HCV assay for Hep-C provides on-the-spot results in just 90 minutes direct from a very small plasma sample.

The trials revealed the technology was highly accurate and performed well against the best-in-class device.

“Application for CE Marking for the Genedrive HCV assay is a significant step in our development of a decentralised and qualitative molecular HCV test, which could be the first of its kind to market,” said David Budd, Genedrive chief executive.

“As we go through this process, we look forward to updating the market with our commercial partnership arrangements and target geographies for initial product introductions.”

Molecular diagnostics 

Genedrive describes itself as a molecular diagnostics company.

It is developing and commercialising a low cost, rapid, versatile, simple to use and robust “point of need” system that accurately picks up infectious diseases.

The Genedrive platform and its MTB/RIF test for tuberculosis have already launched in India.

As mentioned above the HCV test has undergone rigorous and successful testing with researchers in Paris and Nottingham ahead of the start of sales in the EU.

The studies demonstrated an overall sensitivity (accurate diagnosis) of greater than 99% and specificity (people don’t have disease) of 100% over a 955 sample cohort compared to the Abbott Molecular RealTime HCV Viral Load Assay.

The test was aimed decentralised use in areas with limited or non-existent health care infrastructure.


The assay used only a small amount of human plasma, eliminating the need for a separate RNA viral extraction process, and yielded results within 90 minutes.

Professor William Irving, Professor of Virology at Queen’s Medical Centre, said: "The diagnostic and treatment landscape for HCV has changed rapidly in recent years, and with the introduction of direct acting antivirals, there is a real opportunity to tackle the global burden of Hepatitis-C.

“Accurate, decentralised diagnostics, like Genedrive HCV, promise to be a big step forward in addressing the challenges associated with identifying and diagnosing those living with HCV infection and to give them access to this new and effective therapy."

Revenues grow, healthy financial position

Genedrive finished the year to June 2017 in a solid financial position after it saw revenues grow across the board.

For the 12 months to 30 June, the AIM-quoted firm reported group revenues of £5.8mln, comfortably ahead of the £5.1mln it posted last year.

The company closed the period with cash of £5.1mln (2016: £1.1mln), thanks to the £6.5mln it raised ayear previously.

It burnt through £0.6mln in the second half of the year, with cash flows helped out by a £0.8mln tax credit.

Possible sale of services division

Although the services business continues to make a positive contribution to cash flows, Genedrive doesn’t deem it a core part of the company going forward and is looking at the possibility of offloading it.

None of the offers to acquire the division have been acceptable yet, Genedrive said, adding that it is also exploring other ways which would allow the business to best contribute to the group.

US DoD funding

In July, Genedrive received a further US$1.4mln in funding from the US Department of Defence for its handheld biohazard-detection device programme.

It follows successful field trials and brings the total it has received from the Department of Defence to US$6.5mln.

View full GDR profile View Profile

Genedrive PLC Timeline

Related Articles

Proteomics International Laboratories: Access latest PPT from Proactive's CEO Sessions
April 13 2017
Richard Lipscombe talked revenue generation and growth path with investors.
picture of human skeleton
July 21 2017
Tissue Regenix is funding the acquisition with a placing at 10p to raise £40mln
picture of genes
November 29 2017
Among those cited as using Silence’s tech is US firm Alnylam, valued at US$12.7bn.

No investment advice

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable or advisable for any specific person. You further understand that none of the information providers or their affiliates will advise you personally concerning the nature, potential, advisability, value or suitability of any particular security, portfolio of securities, transaction, investment strategy, or other matter.

You understand that the Site may contain opinions from time to time with regard to securities mentioned in other products, including company related products, and that those opinions may be different from those obtained by using another product related to the Company. You understand and agree that contributors may write about securities in which they or their firms have a position, and that they may trade such securities for their own account. In cases where the position is held at the time of publication and such position is known to the Company, appropriate disclosure is made. However, you understand and agree that at the time of any transaction that you make, one or more contributors may have a position in the securities written about. You understand that price and other data is supplied by sources believed to be reliable, that the calculations herein are made using such data, and that neither such data nor such calculations are guaranteed by these sources, the Company, the information providers or any other person or entity, and may not be complete or accurate.

From time to time, reference may be made in our marketing materials to prior articles and opinions we have published. These references may be selective, may reference only a portion of an article or recommendation, and are likely not to be current. As markets change continuously, previously published information and data may not be current and should not be relied upon.

© Proactive Investors 2017

Proactive Investor UK Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use