Epistem is a biotechnology company applying its expertise in epithelial stem cells in the areas of oncology and gastrointestinal diseases as well as dermatological applications.

Epistem has become recognised as a specialist in epithelial tissue and stem cell analyses. Our heritage is based on our expert science and know-how in the field of epithelial tissue and adult epithelial stem cell biology.

Epistem does not conduct research into embryonic stem cells or stem cell transplantation.

Founded in 2000, the Company originally formed part of the Paterson Institute for Cancer Research, UK. The founders and management are international experts in epithelial tissue, tumours and stem cell control and lead a team of experienced scientific staff, with specialist skills in the field.

Located in purpose-built office and laboratory facilities adjacent to The University of Manchester, UK, Epistem maintains close links with drug development companies, clinicians and academics in the field, ensuring that the Company remains at the forefront of stem cell science and technology development.


http://www.epistem.co.uk/

Final Results

RNS


RNS Number : 4182V

Epistem Holdings plc

28 October 2014










RNS Press Release

For release: 28th October 2014: 7.00 AM

Preliminary Results to 30 June 2014



Epistem Holdings Plc (LSE: EHP), the personalised medicine and biotechnology company, announces today its preliminary results for the year to the 30 June 2014. The Company has also announced today in a separate announcement the successful completion of the Genedrive® Indian Tuberculosis clinical evaluation study, and the filing of its Tuberculosis assay regulatory submission.



The 2013/14 financial year saw Epistem commence and successfully complete its Indian clinical evaluation study in advance of the planned launch of Genedrive® (www.genedrive.com), its revolutionary handheld molecular diagnostic device, whilst accelerating investment in its new product development programmes and delivering a solid set of financial results.



Financial and Operating Highlights

· Total sales of £5.8m (2013: £5.4m) driven by improving performance from the Personalised Medicine division and solid results from the Preclinical Research Services division.

· Successful completion of Genedrive® Indian clinical evaluation study and commencement of 'fast track' independently funded Tuberculosis clinical evaluation studies in Nigeria, South Africa, Uganda and Brazil.

· Development of 'Hepatitis C' collaboration with INSERM (Institut National de la Santé et de la Recherche Médicale) and Pasteur Institute for development of 'Hepatitis C' (HCV) test.

· Successful completion of ISO13485 medical device Quality Accreditation with scale up of units and assays underway in preparation for launch of Genedrive®.

· Ongoing patient stratification assessments in clinical trials for Genedrive® pharmacogenomic applications and collaborative discussions.

· Preclinical Research Services sales of £2.9m (2013: £2.9m) with strengthened offering in biodefence, leukemia imaging and rheumatoid arthritis.

· Following high levels of investment made in our Genedrive® technology, the Company reports an after tax loss of £1.7m (2013: £1.2m loss after tax).

· Cash reserves of £4.2m at June 2014, bolstered by recent Global Health Investment Fund investment, with Cash balance at 30 September 2014 of £7.9m.



Recent Developments

· Announcement today of market regulatory submission filed with the Indian regulator (Drug Controller General of India) for a license to import and sell Genedrive® for the molecular diagnosis of Tuberculosis; approval anticipated early in 2015.

· Announcement on 22 July 2014 of $8.0m (£4.7m) collaborative funding agreement with the Global Health Investment Fund I, LLC (GHIF) to support the roll-out of Genedrive® as part of the Global Access Programme.

· Joined Global Alliance TB Drug Susceptibility Test Consortium in collaboration with Bill and Melinda Gates Foundation, TB Alliance and PATH.

· Announcement today of Memorandum of Understanding (MOU) signed with Clinton Health Access Initiative (CHAI) to collaborate in bringing Genedrive® and TB diagnostic assay to markets in resource-limited countries.

Update re Indian regulatory approval
RNS
RNS Number : 9635J
Epistem Holdings plc
13 April 2015





RNS Press Release

For release: 13th April 2015: 7.00 AM


Indian Health regulator notification of import licence for Genedrive TB molecular diagnostic test

Epistem Holdings Plc (LSE: EHP), the personalised medicine and biotechnology company, announces today that in preparation for the launch of its first molecular diagnostic 'Point of Care' product for Tuberculosis, that its Indian partner Xcelris Labs has on 13th April 2015 via the website (http://www.cdsco.nic.in/forms/list.aspx?lid=2012&Id=3) been made aware that the Director General of Health Services, Ministry of Health and family Welfare, Government of India, will publish an approval letter in respect of the licence to import Epistem's Genedrive® Tuberculosis and antibiotic resistance molecular diagnostic kit.


A further update will be issued in due course on receipt of the formal approval letter.

UPDATE - Epistem partner receives licence to import Genedrive TB diagnostic

By Ian Lyall

April 23 2015, 8:14am
Xcelris Labs, Epistem’s distributor, will begin to place the device with key opinion leaders in the country.
Xcelris Labs, Epistem’s distributor, will begin to place the device with key opinion leaders in the country.


---ADDS BACKGROUND AND OPENING SHARE PRICE---

Epistem Holdings’ (LON:EHP) Indian partner has received a licence that will allow it to import the Genedrive molecular diagnostic test for tuberculosis.

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.

proactiveinvestors/epistem-accelerating-global-push-of-unique-tb-diagnostic-device.