ValiRx Regulatory News (VAL)

ValiRx Plc

("ValiRx" or "the Company")

VALIRX LAUNCHES ITS CHLAMYDIA SELF-CHECK

HEALTH SCREENING PRODUCT

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to announce the launch of its Chlamydia SELFCheck "Over-The-Counter" health screening product in the UK.

The retail and distribution of the self-diagnostic tests will be conducted by ValiMedix, the Company's sales and distribution division, and will be targeted at existing and new channels as well as genitourinary medicine (GUM) clinics, wholesalers, multiple and independent pharmacies, and supermarkets initially across the UK and Ireland. The packs are designed for women, can be sold over the counter, are easy to use and will provide a YES/NO result within ten minutes. 

The Chlamydia self-testing product is a single-use diagnostic test for use at home or in a GUM clinic. The detection of Chlamydia bacteria is shown as a colour change on the swab, which is produced within 10 minutes.

Chlamydia infection rates amongst women are increasing markedly in the UK and Europe with an estimated one in ten women aged 20 being infected. Infection can be spread easily and is made worse by the fact that both female and male partners often exhibit no symptoms of the infection and, as a result, are often unaware of their own infection. If left untreated, it can have serious complications. It has recently been estimated that 40 per cent. of women who have untreated Chlamydia may develop pelvic inflammatory disease, a condition in which the internal genital organs are permanently damaged. Women may also develop problems with fertility and experience long-term pain. 

Current tests for Chlamydia require a urine or vaginal swab sample to be sent off for laboratory testing with analysis and test results taking up to 4-5 days. In contrast, the ValiMedix SELFCheck Chlamydia kit, with its high sensitivity and specificity, simplifies and speeds up testing. The result can be obtained in the privacy of one's own home within ten minutes.

The global Point of Care (diagnostic testing at or near the site of patient care) market was worth nearly $13.4 billion in 2009 and is estimated to increase to $18.7 billion by 2014. Market growth is being principally driven by the increased adoption of self-testing by the public.

ValiMedix's Chlamydia product will retail at what the directors believe to be a substantial discount to the prevailing PCR test prices and it will be available in the UK and Ireland with expansion of sales into other territories under discussion. ValiRx has active SelfCheck distributors in Sweden, Slovenia and Switzerland and the product is CE/IVD approved and manufactured by an ISO-approved manufacturer.

Dr Satu Vainikka, CEO commented:

"I am delighted that we are now launching our Chlamydia self-testing product into the UK and Irish markets. With Chlamydia being diagnosed as the fastest growing sexually transmitted disease at the moment, our self-testing pack, as an affordable, easy -to-use and rapid indicator of the presence or absence of the Chlamydia bacterium has the potential to become a first line test against Chlamydia. With the disease having the potential to affect fertility in both sexes, I particularly urge young people looking to start a family to test themselves early. Early detection will mean early intervention and thinking that there is not a problem is just not thinking."

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ValiRx Plc

ValiRx Plc is a biopharmaceutical company developing novel technologies and products in oncology therapeutics and diagnostics. The product focus is in the epigenomic analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases.

The Company listed on AIM in October 2006 and is creating a portfolio of innovative products through investment in specific development projects. It actively manages projects within this portfolio as a trading company and is not an investment vehicle. The ValiRx business model spreads the risks of life science technology developments by minimising financial exposure and running a set of projects to defined commercial endpoints. This maximises returns to shareholders by adding value at the earlier stages where value increases per investment unit are the greatest. 

The Company operates through the following divisional companies:

·; ValiMedix is the sales and distribution division of ValiRx

·; ValiPharma is the therapeutics division with two embedded technologies primarily directed at the treatment of cancers. Of particular note is GeneICE, ValiRx's technology for controlling rebellious genes, which was awarded a Eurostars grant to the value of €1.2 million to fund the development of the GeneICE products through preclinical stages in cancer treatments. ValiRx is leading a consortium of biotechnology companies that are completing pre-clinical studies based on ValiRx's GeneIce technology platform, prior to entering clinical trials.

ValiMedix Ltd is a UK based company dedicated to building itself into one of Europe's largest Point of Care diagnostics companies. Initially this will be achieved through a programme of acquisitions accompanied by the in-licensing of products and product ranges which may be generic or with associated intellectual property that can be commercialised through existing established distribution channels to end users. Once the company is significantly cash positive it will commission its own new products and generate new intellectual property through a series of collaborative partnerships with organisations known to the management team. The core management team has extensive experience of sales and marketing in professional and pharmacy channels including the Over The Counter ("OTC") diagnostic sectors in the UK and overseas.

Over The Counter (OTC) products, SELFCheck and others

OTC screening products have evolved significantly since the introduction of the first generation of products such as pregnancy tests. Current products include screening for cancers, tropical diseases such as malaria, drugs of abuse, as well as the better known devices aimed at cholesterol assessment and selected acute diseases including several Sexually Transmitted Infections ("STI")s such as HIV.

The majority of the OTC tests sold today rely on either chemical or antibody reactions that produce a detectable colour change to read the result. The core technologies employed are reliable and robust with advancement and growth in the sector dependent on accuracy, reproducibility and time of reaction. Tests that have historically taken a number of hours can now be carried out in minutes.

Point of care (POC) products offer rapid, easy to use methods for quantitative or qualitative assessment of a range of disease conditions. The benefit of such tests lies in the availability of test results within a matter of minutes and without a requirement to send samples to centralised laboratories, also removing any need for multiple appointments involving a clinic. The availability of such products via pharmacies and supermarkets appeals to wide sections of the community that find it difficult or inconvenient to make clinic appointments during the working week.

The Market for POC testing - Target Markets

The cost and provision of cost effective healthcare has become a major challenge in the UK and EU where an ageing population, an economic downturn and the ever increasing cost of medical treatment have seen a change in the strategic planning of healthcare delivery. 

Acceptance of POC screening tests offers direct savings in terms of early detection of disease and faster clinical and medical interventions where abnormal outcomes occur. Equally important is the speedy 'all-clear' diagnosis for patients who would have exhibited negative test results but who would still have used up valuable laboratory resource.

The development of drop-in clinics and the expansion of pharmacy services (particularly those prescribing pharmacies) will become a fertile market for POC products. In addition ValiMedix is looking to market its products to Hotel/Spa clinics, health clubs (gyms) as well as the occupational health sector, universities and schools.