SYGNIS Pharma AG Presents Its First Own Product Line Based On PrimPol Technology: TruePrime

• TruePrime™ revolutionizes whole genome and transcriptome amplification

• First product will be developed for single cell DNA amplification

• Evaluation by an industry leading partner for use on own Next Generation Sequencing (NGS) platform ongoing
• Product launch planned for January 2015

Madrid, Spain and Heidelberg, Germany, November 20th, 2014 – SYGNIS AG (Frankfurt: LIO1; ISIN: DE000A1RFM03; Prime Standard) today announced the inaugural launch of its first new product line TruePrime™.

TruePrime™ is the brand name of a series of kits dedicated to the amplification of various DNA or RNA species for a multitude of applications. TruePrime™ stands for a revolutionary change in the way DNA or RNA is amplified. While the current gold standard MDA (multiple displacement amplification) needs short pieces of DNA (“oligonucleotides”) to start off the amplification, TruePrime™ does not need any synthetic random primers. TruePrime™ is based on a combination of SYGNIS’ recently discovered polymerase TthPrimPol and Phi29 DNA polymerase. In this set up, TthPrimPol synthesizes the primers needed for Phi29 DNA pol on the fly, which allows for the amplification of genomic DNAs.

The key advantages of the TruePrime™ product line include complete absence of common artifacts linked to the use of oligonucleotides, a reduced amplification bias compared to methods using random synthetic primers and an exquisite reproducibility when DNA is amplified from single mammalian cells. Moreover, TruePrime™ shows superior sensitivity, is easy to use and works perfectly well with all commonly used NGS platforms such as Illumina and IonTorrent. The Company plans to launch the first kit for DNA amplification from single cells in January of 2015.

Single cell analysis has been named “Method of the year” by the renowned journal “Nature Methods” and today is one of the most exciting but also one of the most challenging applications of NGS. The features of TruePrime™ make this product highly attractive for this type of analyses especially in life science areas such as human genetics, oncology, or pathology where researchers need to obtain biological information from the smallest sample amounts.

“We are very proud and excited about the development of our first kit from our newly introduced TruePrime™ product line. With this product line, based on our proprietary PrimPol technology, we are addressing key challenges in NGS as well as in other downstream applications, where DNA analysis is limited due to small amounts of available sample material down to single cells,” Pilar de la Huerta, CEO and CFO of SYGNIS commented. “In addition, we are driving adoption of NGS into more commercial applications by providing solutions which are compatible with major NGS platforms and support standardization of workflows. Given the superiority of TruePrime™ over all technologies for whole genome DNA amplification available today, SYGNIS is convinced it will benefit from future growth rates and gain a significant portion of the market.”

SYGNIS is currently developing a series of TruePrime™ kits that are expected to be launched throughout 2015 and 2016 to bring the benefits of this new technology to researchers working on a variety of applications. Starting January 2015, the kits will be available via SYGNIS’ own sales channels and through regional and international life science distributors. In addition, SYGNIS is planning to also expand the market for its new products through OEM agreements with international market leading companies.

SYGNIS has cloned, characterized, and patented a PrimPol thermostable version, TthPrimPol, following the seminal characterization of human PrimPol by one of SYGNIS’ scientific fathers, Prof. Luis Blanco, at the end of 2013. On November 12th, Prof. Blanco was granted with the renowned Carmen and Severo Ochoa Prize 2014 by the Carmen and Severo Ochoa Foundation from the Spanish National Research Council (CSIC), which recognizes the work of excellent scientists in the field of molecular biology in Spain. This brand new amplification technology is patent-protected by SYGNIS until 2033.

About PrimPol

PrimPol is one of the most innovative discoveries in the molecular biology field and one of the key products in SYGNIS’ portfolio. Key features of this enzyme family are the duality as a RNA primase and DNA polymerase, and its high tolerance to damaged DNA. The primase function of PrimPol allows it to start reading and copying DNA without the need for providing primers, as required by all other commercially available polymerases. Using random primers can bias the amplification and sequencing results. The polymerase function of PrimPol displays a highly specific activity, being very efficient also when copying DNA with different lesions.

About the Next Generation Sequencing market

Today, NGS is seen as the fastest-growing and most lucrative segment in the genomics market with an estimated annual growth rate of more than 23% in the years to come. The global NGS market volume today is worth $2.5 billion and is poised to reach $8.7 billion by 2020 (MarketsandMarkets, September 2014). While still mostly used in research institutions, ongoing developments for higher throughput, increased accuracy, and cost efficiency as well as value creating data management will make NGS more and more attractive for commercial applications such as diagnostics, drug discovery, biomarker discovery as well as personalized medicine in clinical laboratories, hospitals and in pharma companies.

For further information please contact:

SYGNIS AG
Pilar de la Huerta
CEO/CFO
Phone: +34 91 192 36 50
Email: pdelahuerta@sygnis.es

About SYGNIS AG: www.sygnis.com

Following the merger with X-Pol Biotech in 2012, SYGNIS specializes on the development and commercialization of products for DNA amplification and sequencing. SYGNIS AG, listed at the German Stock Exchange (Prime Standard segment, Tick: LIO1; ISIN: DE000A1RFM03), has a commercial product for whole genome DNA amplification, SensiPhi®, licensed to an industry leading partner and is currently developing its own TruePrime™ product line based on its proprietary PrimPol technology for use in the fast growing field of Next Generation Sequencing. The first product for single cell DNA amplification is expected to be launched in January 2015.

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