To get a new technology accepted is never easy but Epistem (LON:EHP) is making progress on two fronts with its Genedrive diagnostic platform.
A test for Hepatitis C (HCV) has been cleared for clinical trials by the Institut Pasteur in Paris.
An estimated 150-200mln people are believed to have chronic HCV viral infection with 350,000 deaths each year from related diseases.
Now, with the approval from the Institut, Epistem can move to clinical trials as part of a plan to get European CE certification ahead of a launch across Europe in 2017.
Ian Gilham, chairman said: "The commencement of clinical trials of our HCV assay is an important step in our ongoing commercialisation of Genedrive”.
He added this would also pave the way for the development of tests for Hepatitis B and HIV.
Genedrive detects viral RNA, covers all HCV genotypes and is performed at "point of need" medical centres directly on plasma within 90 minutes.
It is also a qualitative test, not a simple yes or no.
This ability to measure the viral load is important for physicians as a new range of anti-viral drugs is hitting the market, said Gilham.
The timetable for the HCV test trials is relatively short. Regulatory approval is required, but the process is not as rigorous as for a medicine.
That should mean the trial being concluded by the end of 2016 and if it all goes well a CE mark being awarded in 2017.
Sales to clinical research labs may also be possible much earlier than that.
In early May, the company reported that Genedrive had performed well in trials in Paris.
The clinical trial showed Genedrive was 100% accurate in detecting inherited genetic polymorphisms in Hepatitis (HCV) patients compared to the current 'gold-standard' laboratory test, Roche's TaqMan PCR.
Epistem said Genedrive also produced results in 50 minutes from a simple cheek swab compared to the standard blood sample test that can take 2-3 weeks.
Epistem’s other big target in the tuberculosis (TB) market in India. A Genedrive test for TB was launched at the end of 2015, while a full commercial launch took place in April 2016, with its partner, Xcelris Labs, looking initially to market the device to the country’s 5,000 private clinical laboratories that screen for TB.
To date, the sophisticated molecular diagnostic approach being pioneered by Epistem has only been available in hospitals.
In December, house broker Peel Hunt said it expected income from the Genedrive device to come through as early as the second half of 2016.
The roll-out of TB technology in India will have a “transformational impact on earnings and cash flow” added the broker.
“Commercialisation in India is an important development to drive increased confidence and, potentially, a material re-rating if Genedrive secures a position in the more than US$1bn tuberculosis testing market, with 2mln new patients diagnosed each year in India alone,” Peel Hunt added.
The broker has a 200p target price for the shares.
Gilham said progress in India was going slowly as it was a big programme and it was important to ensure that studies underway with the major opinion formers in the country went well.
Reflecting the increasing awareness of its flagship product, the company is planning to change its name to Genedrive.
The announcement accompanied news of a £6.5mln fund-raising through the placing of shares at 80p a pop.
The epithelial stem cell biology firm’s cornerstone investor, Calculus Capital, subscribed for 3.13mln shares, as a result of which it will hold 16.7% of the share capital as enlarged by the share issue.