The EU Medical Devices Directive awarded CE IVD certification last September, which clears the molecular-diagnostics company to bring the product to Europe, as well as low- and middle-income countries that accept CE certification under their national regulations.
In October, Genedrive signed a distribution deal with Sysmex Corp., a provider of clinical lab systems, with an eye toward targeting end-users in Africa, followed by the Europe, Middle East and Africa (EMEA) region, and added a second agreement to include Asia-Pacific in November.
“With a strong commercial partner now in place for HCV in EMEA, we look forward to beginning commercialisation activities in certain markets for this important new assay,” said David Budd, Genedrive’s chief executive, in a statement accompanying full-year results in October.
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.
Results of a performance study in Africa, where the virus is particularly prevalent, demonstrated the handheld device’s “robust performance” in a third-party setting and on territory-specific examples.
“We are making good progress with the launch of the CE-marked Genedrive HCV ID kit,” said chief executive Budd. “This is an exciting period of growth and evolution for Genedrive as we transition to a commercial stage point of care diagnostics company.”
A low-cost solution
Genedrive has developed and is 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."
Turnover improved in 2017
In last October’s trading update, the AIM-listed company saw a 14% rise in turnover for the 12 months ended June 30, 2017, thanks to improved development income of £2.6mln, up from £2mln the previous year, and a moderately better services income increase to £3.2mln from £3.1mln.
The financial results marked a smaller trading loss at £4.9mln compared to £5.4mln in 2016.
That said, research and development costs increased in the period, and so did general admin expenses. After an impairment charge and tax credits, the company made a loss of £6.4mln, which represents an increase of 8.5% from £5.9mln in 2016.
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 that 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.