---Adds broker comment and share price---
Stem cell specialist Epistem (LON:EHP) is likely to sign more partners for its Genedrive diagnostic platform, after being granted a CE mark as an in-vitro diagnostic medical device, reckons broker Peel Hunt.
The certification means the test, which is based on its core Genedrive diagnostic platform, can now be sold across the European Economic Area (EEA).
Epistem received the CE-IVD registration for its rapid molecular test for tuberculosis (TB), an infectious and potentially lethal disease, which affects the lungs and causes a chronic cough.
Peel Hunt Analyst Dr Paul Cuddon said: “Genedrive has overcome the first key hurdle, and looks well set to continue to expand the menu, sign more commercial partners and maximise returns from a truly disruptive diagnostics innovation.”
He added that the registration also enables Epistem’s ability to broaden the range of tests across infectious diseases and cancer, where Genedrive has the technical specifications to become a “class leading technology.”
He added: “Not only is Genedrive cheaper than peers, its technical specifications are better.”
Peel Hunt gives a ‘buy’ recommendation on the stock and target price of 515 pence.
City broker Daniel Stewart agrees also giving a ‘buy’ recommendation and 496 pence target.
Epistem is now preparing regulatory submissions for India ahead of its first molecular TB test including patient assessment for antibiotic resistance towards the end of this year.
India has the largest number of TB sufferers in the world with more than two million new cases each year.
Dr Cuddon said: “A low cost, fast point of care molecular test has the potential to make a significant commercial and clinical impact through breaking the chain of disease transmission in rural areas.”
Matthew Walls, Epistem’s chief executive said: "This is an important milestone for the company as we move towards our first significant revenue stream in the commercialisation of Genedrive."
The CE-IVD mark is the first successful registration of a test using Genedrive.
The Genedrive platform provides a 'Point of Care' test applicable to a wide range of viral, bacterial, fungal and somatic mutation disease areas in less than thirty minutes.
Genedrive will be targeted at providing 'gold standard' identification of Mycobacterium tuberculosis and antibiotic resistance testing and will be priced competitively, Epistem added.
In addition to its Genedrive platform Epistem also works in the discovery and development of biomarkers, which are used to monitor the progress of drug treatments.
The share price was up 1 per cent to 404 pence.