Under the terms of the agreement, Abbott will obtain exclusive distribution rights in the U.S. and all global territories, apart from France, Spain, Portugal and the Benelux countries, once regulatory approvals are obtained.  The agreement includes rights to distribute the SSPGo products, interpretation software Verdict, as well as kit updates and improvements.

Biofortuna has proprietary freeze-drying capabilities resulting in diagnostic kits that are stable at ambient temperature for up to 16 months, eliminating the requirement of refrigerators, freezers and temperature-controlled shipping.  The kits’ one-step procedure – the addition of DNA – offers significant cost and time savings to the end user by reducing labour, consumables and the potential for errors.

As well as developing a number of freeze-dried molecular diagnostic products targeted at the transplantation and pharmacogenetic markets, Biofortuna is developing a portfolio of additional tests with the aim of providing easy-to-use diagnostics that address complex genotyping issues.

Dr Mike Bunce, founder and CSO of Biofortuna said ‘’We are delighted to have signed this agreement with Abbott.  Biofortuna’s expertise in HLA and freeze-drying combined with Abbott’s sales and marketing infrastructure and excellent customer support, will meet the growing demand for our kits.’’

The SSPGo product range is the first freeze-dried HLA-typing kit of its kind.  The kits will be available to laboratories outside the U.S. to purchase and order through Abbott in June 2011.  The kits are currently CE-marked and have been submitted for U.S. FDA approval.

About Biofortuna Ltd

Biofortuna Ltd, the UK-based molecular diagnostics company, specialises in proprietary freeze-dried HLA diagnostics.  Biofortuna have a number of freeze-dried molecular diagnostic products targeted at the transplantation market.  It is also developing a portfolio of additional tests with the aim of providing easy-to-use diagnostics that address complex genotyping issues, whilst increasing laboratory productivity and improving quality in clinical testing and patient care.

Biofortuna’s news releases and other information are available on the company’s website www.biofortuna.com

Biofortuna Media Contacts

Dr Mike Bunce

Chief Scientific Officer

E: mike.bunce [Email address: mike.bunce #AT# biofortuna.com - replace #AT# with @ ]

Harry Singh

Commercial Director

E: harry.singh [Email address: harry.singh #AT# biofortuna.com - replace #AT# with @ ]

Biofortuna Ltd has a number of freeze-dried molecular diagnostic products targeted at the transplantation market. It is also developing a portfolio of additional tests with the aim of providing easy to use diagnostics that address complex genotyping issues, while increasing laboratory productivity and improving quality in clinical testing and patient care.

As the former Executive Chairman of Lab 901 Ltd, Simon guided the business through its strategic growth and eventual acquisition by Agilent Technologies Inc. Previously to this Simon was the CEO of the Life Science Company Tepnel PLC and CEO of DNA Research Innovations Ltd (DRI) which was acquired by Invitrogen Corporation in a deal worth over $60million.

Dr Mike Bunce, Biofortuna founder and CSO, said “I am delighted to welcome Simon to the Management Team at Biofortuna. Simon’s 25 year experience in the medical diagnostics sector coupled with an excellent track record of building value for investors within the diagnostic sector will be invaluable for Biofortuna. The Management Team and I look forward to working with him.”

Dr Simon Douglas said “I am delighted to be joining the Board of Biofortuna Ltd at a stage where the company is going through tremendous growth and significantly increasing its portfolio of tests.’’

The funding, provided alongside Catapult Venture Managers, Merseyside Special Investment Fund and the company’s Non-Executive Directors, is part of a £1million funding package, which will be used to develop the market for the company’s diagnostic genotyping products and to allow it to continue development of its future product pipeline.

The company designs and develops innovative genotyping and antibody screening tests for the clinical healthcare market. It creates easy-to-use diagnostics that address complex genotyping issues. Its novel processes, extensive experience and patented techniques are directly applicable to genetic tests for use in organ transplantation and management, blood banking, disease identification, microbiology and pharmacogenomics. Its tests aim to increase laboratory productivity and improve quality in clinical testing and patient care.

Mike Bunce, CEO of Biofortuna Limited, commented, “Biofortuna is very pleased to continue working with our investors EV, Catapult, Liverpool Seed Fund and our external investors. This further investment will enable us to continue to develop our ground breaking freeze dried diagnostic kits and consolidate our position as a unique global innovator in clinical diagnostics and lyophilisation techniques.

Mark Hurley, Chairman of Biofortuna Limited, commented, “We have seen Biofortuna make outstanding progress in the last year, and this latest investment clearly demonstrates that the Board’s confidence and enthusiasm is shared by our external investors. We are delighted to have the continued support of EV, alongside Catapult and Liverpool Seed Fund and we are all looking forward to further innovation and enhancement of our products, and to the company’s continuing success.

Legal advice to the Investors was provided by Jon Gill of Eversheds, and to the company by Craig Scott and Richard McKay of Hill Dickinson.
Ends

About Biofortuna Limited

Transplantation of bone marrow and solid organs (e.g. heart, kidney and lungs) carries a risk of rejection. To minimise this risk, both patients and donors undergo DNA typing for the major transplantation antigens, known as HLA antigens, and screening for the presence of antibodies that are directed at potential donor HLA antigens. There is a variety of methods for carrying out these tests already available on the market but they are either difficult to perform in large quantities and are therefore time consuming and expensive, or they can be carried out relatively quickly but provide a low specificity and resolution and therefore provide relatively coarse results when trying to match donor with recipient. Speed and accuracy of testing is important in solid organ transplantation: helping prevent organ rejection, easier interpretation of tests and helping reduce the cold storage time of organs which is a major factor in early function of a transplanted kidney.

Biofortuna has developed a unique range of products to provide both speed and accuracy to genotyping and antibody screening thereby reducing the number of transplants that fail and, in so doing, reduce post-transplantation mortality rates. Survival rates have improved over the last 20 years but despite this, 7% of solid organ transplants fail in the first year, rising to 17% after 5 years. 4% of recipients of solid organ transplants die within the first year (UK Transplant audit 2008).

The fundamental premise for the Biofortuna product range is to produce exceptional, cost-effective quality products that improve ease of use and thereby reduce error and above all to improve specificity and accuracy compared to those products currently available. The first of these products is a unique complete dried PCR system for genotyping HLA. The system has the benefit of greater simplicity, speed and accuracy over conventional systems with the added benefit of being ecologically sound as the kits are entirely stable at a wide range of temperatures thus removing the need to ship or store on ice. Biofortuna intends to apply this philosophy of accurate, easy to use methodology that is ecologically sound to all future products.

Biofortuna’s technology platform can be adapted to provide genotyping products to identify potential adverse drug reactions or check the efficacy of expensive drugs such as immunosuppressant’s. There are very few approved pharmacogenomic tests available at present; however increased healthcare costs and improved knowledge of how genetics influence the effects of drugs have led to rapid growth and a significantly increased demand for such tests.

The award-winning firm, led by internationally renowned HLA molecular immunologist Dr Mike Bunce, is revolutionising clinical testing methods with its proprietary freeze-dried ‘SSPGo’ technology.

SSPGo is a novel single-step, off-the-shelf freeze-dried SSP PCR mix containing all buffers, primers and Taq. Users simply add DNA to the unique lyophilised formula for the ultimate in accuracy and user simplicity.

Unlike traditional SSP kits, SSPGo is stable at ambient temperature for at least 12 months, removing the need for fridges, freezers and thermal packaging during shipping and storage.

Biofortuna’s team of world-class scientists are taking clinical innovation to new levels and leading UK organisations, including some NHS trusts, have already placed orders for the technology, while international enquiries are flooding in from as far afield as the US, Canada, India and Europe.

The cutting-edge freeze-dried technology has multiple benefits for laboratories including reduced user error, contamination, manual labour, and a reduction in the use of tips, tubes, racks and shipment packaging.

The kits, which come with free interpretation software, are updated after every alignment update based on the IMGT database. SSPGo can be used on current PCR and gel electrophoresis platforms.

SSPGo was created by Dr Mike Bunce, whose career combines almost 30 years’ clinical and industrial experience.

Dr Bunce, CEO of Biofortuna, said: “We are delighted to officially launch SSPGo to the marketplace. This is the only freeze-dried PCR reaction mix available where you just add DNA and PCR. Our unique lyophilised PCR includes all buffers and taq, removing batch pipetting, variability and ultimately improving test set up time, accuracy and cost. The feedback from the industry has been tremendous and we are very excited about SSPGo’s potential for rapid global growth.”

With sales expected to rise 25% year on year, Biofortuna has just quadrupled the size of its offices in the Liverpool region of the UK, to incorporate four new state-of-the-art laboratories and equipment facilities, with additional shipping and warehousing space.

The Biofortuna management team has also expanded with the company recently welcoming non-executive director Dr David Whitcombe onboard.

David has an extensive background in biotechnology and was a founder of DxS Ltd, a UK based molecular diagnostics company sold to Qiagen in 2009 in a deal worth £80M.

Biofortuna is developing a range of unique HLA diagnostic kits for the transplantation, blood grouping, disease identification and pharmacogenetic markets.

The company specialises in easy to use diagnostics that address complex genotyping issues, while increasing laboratory productivity and improving quality in clinical testing and patient care.

The Biofortuna team will be demonstrating their cutting-edge technologies at both the BSHI and ASHI Conferences in Edinburgh and Miami respectively this week.

Biofortuna is an ISO 9001:2008 company and manufacture to ISO 13485 standards. All products manufactured for In Vitro Diagnostic use carry the CE mark for compliance with the EU In Vitro Diagnostic Directive (IVDD).

CleanAmp™ dNTPs gave Biofortuna a viable alternative to the more commonly-used approaches to Hot Start PCR. Biofortuna was able to improve the specificity of their genotyping assays by replacement of the standard dNTPs with CleanAmp™ dNTPs.

“Combining CleanAmp™ dNTPs with our novel lyophilisation methods creates the ultimate in high quality easy-to-use PCR assays. All Biofortuna freeze-dried kits are self-contained, including polymerase: to perform the test, all the customer has to do is add DNA to the assay and then PCR. Inclusion of CleanAmp™ dNTPs allows us to create accurate, reproducible and simple diagnostic kits, that greatly improve the quality of clinical testing and patient care,” said Biofortuna CEO, Dr. Mike Bunce.

“CleanAmp™ dNTPs greatly help our production process and allow us to produce quality products. An added benefit is that our kits are environmentally friendly; the kits are stable at ambient temperature and therefore do not require fridges, freezers, thermal protection or cool packs during shipping or storage,” said David Charvill, Biofortuna Operations Director.

“CleanAmp™ dNTPs offer a unique approach to Hot Start activation in PCR by chemical modification of the essential DNA polymerase substrate, the dNTPs. This versatile reagent can be used with different DNA polymerases and a variety of assay formats. We are pleased to provide CleanAmp™ dNTPs for the advancement of Biofortuna’s technology,” said Dr. Natasha Paul, TriLink Scientific Investigator.

“The ability to provide emerging companies with a cost-effective, easy-to-commercialize solution for high stringency PCR kits was the main driving force behind the development of our CleanAmp™ Products. We are excited to see our collaboration with the innovative people at Biofortuna come to fruition,” said TriLink CEO, Dr. Richard Hogrefe.

About TriLink
TriLink manufactures custom oligonucleotides, modified nucleoside triphosphates and CleanAmp™ PCR products for the diagnostic and OEM markets. In addition, custom chemistry, contract research services and ISO/QSR compliant cGMP production facilities are offered. TriLink’s solutions help advance drug discovery and biomedical research. Founded in 1996, TriLink is a privately held firm based in San Diego, California and employs approximately 80 scientists and other professionals. For more information about the company and products please contact:

TriLink BioTechnologies
Shawna Leaver, 858-546-0004
sales [Email address: sales #AT# trilinkbiotech.com - replace #AT# with @ ]
www.trilinkbiotech.com

About Biofortuna
Biofortuna is an award-winning molecular diagnostics company providing easy-to-use, high quality HLA molecular diagnostics. Biofortuna have created the world’s first freeze dried PCR reactions. Users simply add DNA to pre-dispensed, freeze dried PCR reactions allowing for the ultimate in user convenience. Biofortuna’s diagnostic kits are simple, quick and consistent, providing accurate, high quality results. The kits superior stability allows storage and transportation at ambient temperature eliminating the requirement for fridges, freezers and thermally controlled shipping. With their patented freeze dried technology, expertise in HLA, and a passion for quality, Biofortuna’s diagnostic kits offer significant advantages over its competitors. For more information about the company and products please contact:

Harry Singh
Commercial Director
Biofortuna Ltd
harry.singh [Email address: harry.singh #AT# biofortuna.com - replace #AT# with @ ]
www.biofortuna.com
Tel: +44 (0) 151 334 0182 ext 202

The funding will be used to launch the company’s first diagnostic genotyping products and to allow it to continue development of its future product pipeline.

The management team is led by CEO Mike Bunce and fellow Directors, David Charvill and Ben Passey, who, following this funding round, will be joined by Dr David Whitcombe, who was part of the founding team of DXS, a North West based Molecular Diagnostics company sold to Qiagen in 2009 in a deal worth £80M. Additionally, Geoff Orme joins as financial director.

Mike Bunce commented, “Biofortuna are very pleased to be working with two new successful investment firms, EV and catapult, who join our existing investment firm of Liverpool Seed Fund. This investment will ensure that the strong progress we have made in the last year will accelerate and help our innovative product portfolio expand over the next year. The new investment will help us to strengthen our team and expand our research and manufacturing capabilities as we look forward to launching more products throughout 2010 and beyond. We thank Halliwells’ Corporate Partner, Craig Scott and Associate, Richard McKay for advising Biofortuna on this deal. In addition, we would like to thank Mark Hurley and Lorna Green for their help and advice in fundraising.”

Julian Viggars, EV’s Head of Technology, said, “Biofortuna is a business we have tracked for a number of months now. I believe it is very well placed to benefit from the progression in thinking around how innovative, easy-to-use genotyping products will increasingly be used in the management of organ transplant processes, to identify potential adverse drug reactions or check the efficacy of expensive drugs across pharmacogenomics.”

“Mike and his team have built the company around a deep knowledge of the current marketplace and are highly rated. In David Whitcombe, we have added a manager who has been involved in building and very successfully exiting a related business, and with co-investor Catapult, the company now has the strong financial backing that will be required to succeed.”

Ben Bolt, Investment Director at Catapult, commented: “Biofortuna has all of the key ingredients that Catapult looks for in a successful early-stage investment. This includes a management team combining both scientific and commercial skills and headed up by a thought-leader in the field.  In addition, the company is benefiting from the addition of an experienced non-executive director. Add to this core products with genuine and proven USPs, a mature product development pipeline and a market that is innovative, embraces change and is growing; and this is a very exciting investment. We look forward to helping Mike and his team grow the Biofortuna brand.”

Legal advice to Catapult Venture Managers and EV was provided by James Trevis and Jon Gill of Eversheds, and to the company by Craig Scott and Richard McKay of Halliwells.

The rapid progress in quality management is testament to the dedication and skill of our quality team and our consultant Dave Ashworth from Flintloque Management Systems.

(See also www.lrqa.co.uk and www.flintloque.co.uk)

The award to Biofortuna is recognition of the progress we have made from a small start-up company to manufacture of our first products in little over a year; this reflects a real team effort from everyone at Biofortuna and the vital external support from Liverpool Ventures, MSIF, NWDA and the 2Bio team at MerseyBio.

Picture: Graham Bond of Baker Tilly (right) presents the Start-up of the Year award to Mike Bunce (left).

(See also www.bionow.co.uk/news/northwest-biomedical-awards-winners-announced.html)

(Also featured in the Bionow May newsletter)