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project info
Start date: 4 March 2016
End date: 30 June 2019
funding
Fund: European Regional Development Fund (ERDF)
Total budget: 199 801,00 €
EU contribution: 108 791,64 € (54,45%)
programme
Programming period: 2014-2021
Managing authority: Subdirección General de Gestión del FEDER, de la Dirección General de Fondos Europeos del Ministerio de Hacienda.

TruePrimeDo-LB: an innovative method for DNA amplification in liquid biopsies. The main objective of the project is to adapt TruePrime technology to the amplification of minimum amounts of tumor DNA present in liquid biopsies.

SYGNIS, is a biotechnology company specialised in the development of innovative molecular tools in the field of next generation sequencing (NGS). Since its founding in 2008, Sygnis has gained extensive experience in developing new methods of amplifying and sequencing DNA from a new and broad family of polymerases of which the company owns. In recent years, one of its most important projects has focused on the study and characterisation of a thermostable member of the new family of enzymes called PrimPol, which combines raw activity and polymerase into a single polypeptide. The properties of this enzyme have made it possible to design a new amplification system (TruePrimeDo: combination of PrimPol+Polimerase from Phi29). which has allowed the company to directly market its first kits (TruePrimeDoSingle Cell WGA, TruePrimeDo, TruePrime¿RCA) opening the doors to the development of a wide range of products for the amplification of different types of DNA and RNA samples. “Liquid biopsy” is a term recently used to describe diagnostic procedures based on the analysis of nucleic acids obtained from liquid samples of patients (blood, urine, cerebrospinal fluid) (Crowley, Di Nicol Antonio, Loupakis, and Bardelli, 2013; Speicher and Pantel, 2014). Today, the liquid biopsy technique is very promising as it could revolutionise early cancer detection, as well as optimise the focus on treating cancer patients. The main characteristics of liquid biopsy that make it a technique superior to traditional biopsy are the following: a) It is a less invasive method, b) It allows continuous monitoring of cancer throughout a treatment, which leads to an improvement in clinical management and c) contributes to a more timely control of future recurrences of the disease. However, technical approaches to liquid biopsy today have limited reliability, especially in the early phase of different types of cancer (Bettegowda et al., 2014). Some deficiencies in this technique are preventing it from having a greater incorporation in clinical management. In particular, the main limiting factors to be addressed are: improving the sensitivity and specificity of the technique. In this context Sygnis Biotech in collaboration with the Ramón Domínguez Foundation and the Health Research Institute of the San Carlos Clinical Hospital (IdISSC) present the project entitled "TruePrimeDo-BL: an innovative method for DNA amplification in liquid biopsies", with which it aims to improve the sensitivity and reliability of liquid biopsy in the area of oncology, and commercialise this technical solution in the form of a kit. The project is based on the first-free genome amplification technology of which Sygnis owns. TruePrime is the latest and most advanced complete genome amplification technology with less bias in the genomic coverage of amplified products, and a high ability to detect variants due to a very low error rate, and a low rate of allelic dropout. These properties suggest TruePrime as the ideal method for improving current approaches to liquid biopsy. Taking into account: a) the main features of TruePrime technology, and b) Sygnis’ experience in developing DNA amplification kits, the application of TruePrime in the field of collaborative liquid biopsies will result in an innovative method to reliably and easily detect cancer-related mutations, while it can be used for continuous monitoring of cancer treatment.

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