Novacyt Announces Clinical Trial Collaboration with the St Stephen’s AIDS Trust to Expand Potential Market Opportunities of Its Core NOVAprep® Technology

Regulatory News:

Novacyt (ALTERNEXT:ALNOV), an international specialist in cancer and infectious disease diagnostics, updates the market on its intentions to progress new market opportunities for its NOVAprep® technology and, in particular, a new collaboration with the UK’s National Health Service (NHS), specifically the St Stephen’s AIDS Trust Ltd, through a master agreement for clinical trials.

Novacyt has signed a five year master clinical trial agreement with the St Stephen’s AIDS Trust which is linked to Chelsea and Westminster Hospital and Imperial College London. The aim of the first study is to develop a human papilloma virus (HPV) screening programme for homosexual men in the growing problem of anal cancer.

The St Stephen’s AIDS Trust is one of the largest human immunodeficiency virus (HIV) trusts in Europe and it is linked to the Dean Street Express clinic in London Soho, which diagnoses up to 350 patients with sexual health problems per day and will typically offer treatment within hours.

Under the agreement, Novacyt will use its NOVAprep® technology to provide free tests to homosexual male patients in order to study and establish an appropriate HPV screening algorithm. Moving forward, the collaboration will seek to involve other interested parties, such as pharmaceutical companies, to provide a much needed solution and recommendation for a potential national anal cancer screening programme.

Every year, 30,500 new cases of anal cancer occur globally and the majority of cases (over 80%) are thought to be caused by HPV infection¹. The prevalence of HPV infection has caused a significant increase of anal cancer over the past decade and the cost of a comprehensive treatment regime for anal cancer is estimated to be £2.7m in the UK².

Gary Whitlock, MD, PhD, Consultant Chelsea and Westminster Hospital, London, commented:

"Several UK institutions, including the Medical Research Council and the Wellcome Trust, have called for investigation into whether screening homosexual men for HPV is useful and cost-effective. Currently there is no scientific data available on how frequently homosexual males should be screened. In comparison to female cervical screening, which is well understood and described as being effective every five years, sexually active homosexual men might need screening as often as every six months and homosexual males have an increased chance of being diagnosed with anal cancer³, which also has a poor five-year survival rate. We are therefore pleased to be working with industry specialists, such as Novacyt, to address this real problem”.

As previously announced, Novacyt’s NOVAprep® technology with its proprietary and unique vial and medium, has a growing number of market opportunities in addition to its use in liquid based cytology for cervical cancer screening. The Company is already working with a number of molecular platform manufacturers to potentially incorporate the NOVAprep® vial and medium to address the need for high quality patient sample collection and DNA preservation and storage.

In particular, there are a number of business development opportunities for Novacyt to support cancers linked to HPV infection and in the bio-banking of patient samples for future molecular screening. In addition to Novacyt’s collaboration with the St Stephen’s AIDS Trust, the Company expects to announce a number of scientific and commercial partnerships with specialists in these markets in the near future.

Graham Mullis, Group CEO of Novacyt, commented:

"We are very excited to announce our intention to expand into other cancer markets which have the potential to create more shareholder value from our proprietary NOVAprep® technology. Novacyt is already a specialist in certain infectious disease and cancer diagnostic markets, and in the UK I am delighted to announce our clinical trial collaboration with Chelsea and Westminster Hospital, who we have worked with for many years, particularly in specialist HIV testing. I look forward to updating our shareholders in the future with the progress of this collaboration and the specific clinical applications that could result for our NOVAprep® technology.”

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About Novacyt Group

The Novacyt Group is a leader in the field of cellular diagnostics with a growing portfolio of cancer and infectious disease products and services. Through its proprietary technology platform NOVAprep® and a strong international network Novacyt is able to provide an extensive range of oncology and infectious disease diagnostic products. The Group has diversified sales from diagnostic reagents used in oncology, microbiology, haematology and serology markets, and its global customers and partners include major corporates.

For more information please refer to the website: www.novacyt.com

About St Stephen’s AIDS Trust Ltd

Stephen's AIDS Trust was founded in 1991 by Professor Brian Gazzard and a team of colleagues in response to the HIV/AIDS global pandemic. The goal was, and is to this day, to provide the best possible treatment in the best possible environment.

¹ Cancer Stats 2014
² Keeping at al, BMC 2014, 14:1123
³ Evans, David (2008-06-10). "Pap Smears for Anal Cancer?". AIDSmeds. New York: Smart + Strong

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