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Epistem Holdings’ (LON:EHP) Indian partner has received a licence that will allow it to import the Genedrive molecular diagnostic test for tuberculosis (TB).
Chief executive Matthew Walls said the green light from the Indian government provides “a powerful endorsement of our strategy of developing Genedrive for infectious diseases”. The licence runs for three years.
Xcelris Labs, Epistem’s distributor, will begin to place the device with key opinion leaders in the country.
It will also train and carefully monitor the operation of the first Genedrive field-based units to ensure the “rapid and accurate diagnosis of TB sufferers”.
CEO Walls said: “We are now focused on obtaining the support of Indian based key opinion leaders to support the use and adoption of our device and assays.
“We see great potential for our TB test and its technical and commercial advantages for roll out in low income and developing countries in addition to the emerging potential for our Genedrive platform in other disease areas.”
Genedrive is initially being targeted at TB market, but Epistem has been investigating its use in malaria, dengue fever, typhoid, HIV, HCV and a range of sexually transmitted diseases.
Epistem is expecting big things of its handheld diagnostic device, which can produce test results for a range of conditions within 30 minutes.
It is aiming to provide a 'gold standard' for the identification of TB and antibiotic resistance.
The World Health Organisation has publicly recommended that nations incorporate new rapid molecular tests for TB into their disease testing into their programmes.
After India, the plan is to roll out the Genedrive TB test worldwide.
The shares, up 33% in the past month, opened slightly higher at 318.7p each, valuing the business at just shy of £32mln.