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genedrive (GDR.LON), an emerging UK medtech company, focuses on the development and commercialization of an innovative, point-of-care diagnostic system, also called Genedrive® (in this report, "genedrive" (GDR.LON) refers to the company, whereas "Genedrive®" indicates the product). genedrive (GDR.LON) is poised to become the first company to launch a decentralized Hepatitis C diagnostic, entering a large market at a time when new curative therapies for the disease are transforming opportunities for testing and treatment. A Genedrive® TB diagnostic has already been launched and the platform has a wide range of alternative applications.
The Hepatitis C test development is a significant step in a strategic realignment of the company to exploit the opportunities Genedrive® presents in point-of-care applications. The Company estimates a market of $1bn exists for its infectious disease pipeline but, at present, this is delivered from expensive, hospital based settings. In Hepatitis C, new drugs which have the potential to cure the disease are now being made available in certain low income countries at affordable prices, opening up a significant diagnostic market opportunity. The Genedrive® test is uniquely positioned to support a strategy of testing and treatment in these markets.
To better understand the background to the Genedrive® platform and where the company is heading next, it is useful to briefly look at their history. The company was originally set up as Epistem in 2000 and was then listed on London's AIM in 2007. Epistem operated as a niche CRO, providing pre-clinical research services in areas such as tissue damage, regeneration and metaplasia. At the same time Epistem kept investing in internal R&D, building up a significant expertise in biomarkers and assays. These R&D efforts ultimately led to the development of the Genedrive® diagnostic platform. Genedrive® was first launched in 2016 in India, as a point of care test for the diagnosis of tuberculosis and the simultaneous assessment of rifampicin resistance (MTB/RIF test).
As the market opportunity for Genedrive® became clearer in its size and appeal, the company's board was of the view that keeping two increasingly different businesses under the same roof wasn't any longer in shareholder's best interests. As such they decided to concentrate genedrive efforts on the launch of their diagnostic system and, at the same time, to explore strategic options for the legacy CRO operations.
Genedrive® is a CE-marked, lower cost option for the diagnosis of infectious diseases at point-of-care. It is based on polymerase chain reaction (PCR) technology, which has so far been confined to larger desktop analyzers. By contrast Genedrive® is about the size of a book, weighs 1kg and works on either grid or battery power. As such, Genedrive® represents an ideal option for small and medium size rural labs and clinics in developing countries. As the average clinic using Genedrive® is likely to run about 10 test per week, it would likely be uneconomical for them to purchase a sophisticated desktop analyzer.
The company plans to commercialize their Genedrive® platform with a classic razor-razorblade model, largely implemented through distribution agreements.
After launching their MTB/RIF device in India in 2016, genedrive in now preparing for the commercialization of the hepatitis C (HepC) testing device.
Having submitted in April 2017 the CE mark application for the HepC kit, genedrive is now near to becoming the first company to launch a point-of-care diagnostic system for HepC in the second half of 2017.
Although the development of Genedrive® has been largely focused on infectious diseases, it is worth noting that its technology is potentially suitable for a wide range of applications, as testified by the ongoing collaborations with the UD Department of Defense (battlefield biohazards testing) and with CEFAS (fish cultures water testing).
Genedrive® is a small, portable device for the diagnosis of infectious diseases, based on the analysis of body fluids samples.
The system can run one test at the time, with results ready in about one hour.
Genedrive® ease of use and affordability make it an ideal tool for rural clinics and labs serving communities that would otherwise be left out of any other molecular diagnostic option.
From patients' perspective, the cost of a test conducted with Genedrive® is comparable to the cost of a test done with traditional desktop analyzers at large hospitals' centralized laboratories ($20-$30 in emerging markets).
However Genedrive® use at point-of-care allows for treatments to start straight away, rather than waiting a few days or longer for test results. That is assuming access to larger diagnostic centers is available, which is rarely the case in emerging countries rural communities.
The global market for HepC testing is estimated by the WHO at around $500mln, of which approx. 25% or $125mln in high-burden developing countries. Given the current lack of point-of-care diagnostic options we believe that the launch of Genedrive® may significantly expand this market over time.
Of course having a diagnosis is only important as long as treatments are available. In this respect it is important to highlight the increasing access to latest generation HepC medicines in emerging markets. A 12-week treatment course for the cure of HepC still fetches a price close to $100,000 (per patient) in US and Europe but is now being made available in emerging markets for $300-$900.
According to the WHO, tuberculosis remains a top killer in emerging countries, with over 10 million cases every year and almost 2 million deaths. Almost 80 million sputum spear microscopy tests are performed each year, but market share is progressively being gained by molecular diagnostic systems that are able to test both for the disease and for the antibiotic resistance profile.
In the coming months we expect genedrive to update the market on several key fronts:
• CE mark for the HepC Genedrive® system expected by mid-2017
• Distribution agreements for the commercialization of the HepC device in high burden countries
• Launch of Genedrive® for the diagnosis of HepC
• Next steps for Genedrive® development in other diseases
• Ongoing strategic reassessment of their legacy CRO business
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