FILODIAG project for real time Laser PCR diagnosis in less than 15 min
Munich, Germany – 19 February 2015 – GNA Biosolutions GmbH (‘GNA’), a company developing ultra-fast diagnostic instruments for human pathogens, announced today the start of the FILODIAG (Filovirus Diagnostics) project for developing an ultra-fast Ebola detection system based on GNA’s novel Laser PCR technology. GNA is leading a consortium of the Mendel University in Brno (Czech Republic), the Istituto Nazionale per le Malattie Infettive “Lazzaro Spallanzani” (Italy) and the Italian NGO EMERGENCY. The Project Number 115844 of this Ebola+ programme will be funded with EUR 2.3 million by the Innovative Medicines Initiative.
There is an urgent need for fast and accurate diagnostic tests in the current and any future Ebola crisis. The rapid diagnosis of Ebola Virus Disease (EVD) during early and late stage of infection is a decisive step for risk assessment and for guidance to physicians to take the necessary decisions to limit the spread of the infection, and to safely nurse the infected patients. While fast and easy-to-use tests usually rely on immuno-diagnostic approaches, they typically lack high sensitivity and specificity. The gold standard for accurate diagnostics is Real-Time PCR but this procedure requires special laboratory facilities and a long processing time of up to several hours. Aim of the FILODIAG project is to deliver a potentially multiplexed diagnostic system fast enough for point-of-need testing of incoming patients as well as at critical infrastructure checkpoints like airports by withdrawal of blood, or less invasive fluids, such as saliva or urine.
The core technology being used is based on GNA’s laser-heated nanoparticles (Laser PCR) that helps to overcome the time-limiting step of heating and cooling the reaction sample in conventional PCR reactions. GNA have revolutionized this standard procedure by inducing the necessary temperature cycles with laser-heated nanoparticles that can be heated and cooled more than a million times faster than in conventional PCR. GNA has already performed Ebola Laser PCR assays that detect 10 target copies of synthetic nucleotides, corresponding to the Ebola genome sequence, in less than 12 minutes.
Members of the Department of Chemistry and Biochemistry at Mendel University, Brno, will work on integrating the sample preparation with virus-binding magnetic particles. Leading scientist Dr. Vojtech Adam explains: “We will synthesize, characterize and modify the surfaces of nanomaterials to achieve a highly specific binding of viral proteins that will allow for a faster preparation step from patient samples.”
Project coordinator Dr. Lars Ullerich, a Managing Director of GNA, said: “We are working with our international partners to develop a highly sensitive and specific Laser PCR assay based on saliva, urine or blood for Ebola detection. Our proprietary Laser PCR with ten times faster cycles allows us to utilise the gold standard of PCR also in Ebola diagnostic. Together with a label free detection, the test results will be available in less than 15 minutes. Our Pharos400 system can already detect other highly dangerous pathogens within three minutes and a rapid, simple testing workflow will be crucial to deliver effective support in the management of Ebola outbreaks.”
Dr. Antonino Di Caro, director of microbiology, National Institute for Infectious Diseases “Lazzaro Spallanzani”, will test the device and the assay in a biosafety level 4 laboratory in advance of EMERGENCY conducting field testing in their recently established Ebola treatment centre in Sierra Leone.
The FILODIAG project is being funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115844 (www.imi.europa.eu/content/ebola-programme). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. IMI2 has recently launched the programme Ebola+, in which eight funded projects have been announced, including FILODIAG, and two further projects with a diagnostic focus. The FILODIAG project will present future progress on the website www.filodiag.eu.
|Dr Lars Ullerich
Project Coordinator FILODIAG
Managing Director at GNA Biosolutions
About GNA Biosolutions
GNA Biosolutions is developing a pipeline of diagnostic instruments and assays for robust, ultra-fast detection of important human pathogens based on its proprietary Laser PCR technology. The world’s fastest thermal cycles for DNA amplification and detection can be achieved by ultra-fast laser-heating of nanoparticles within the sample solution, an optothermal technology that allows heating and cooling rates many orders of magnitude faster than other PCR methods. The localized nano heating technology is combined with fluorescent-free DNA detection, making ultra-fast DNA-based tests possible within 15 minutes or less. GNA Biosolutions has designed and manufactured the Pharos400 instrument that works with 8-plex test cartridges offering a simple and cost-effective detection of multi-resistant pathogens like MRSA or viruses at point-of-care.
GNA Biosolutions GmbH was spun-out of the Institute for Photonics and Optoelectronics at Ludwig-Maximilians-Universität, Munich, in 2010, and is located in the Innovation and Start-Up Center for Biotechnology (‘IZB’) in Martinsried near Munich. For more information please visit the website: www.gna-bio.com
About Mendel University in Brno
Mendel University in Brno consists of five faculties and one university institute, covering agricultural, forestry, biological, economic, technical and pedagogical sciences. The Laboratory of Metallomics and Nanotechnology is focused on several areas of research, covering modern electrochemical methods, synthesis of nanomaterials such as quantum dots and magnetic nanoparticles, nanomedicine, and nanoelectronics. Within the FILODIAG project, materials and protocols will be developed for an advances virus concentration and processing.
For more information please visit the website: www.mendelu.cz/en/
About Istituto Nazionale per le Malattie Infettive “Lazzaro Spallanzani”
The National Institute for Infectious Diseases (INMI) “Lazzaro Spallanzani” is a public research institution dedicated to infectious diseases. The institute serves as the Italian National Referral Centre for the management and diagnosis of highly transmissible infectious diseases. Since 2003, INMI is member of the Global Outbreak Alert and Response Network (WHO), and in 2009 it was appointed as a WHO collaborative center for clinical care, diagnosis, response and training on highly infectious diseases. INMI has diagnostic, patient care and research facilities, all placed in a large campus. The new instrument will be tested at INMI with relevant samples.
For more information please visit the website:www.inmi.it
EMERGENCY Ong Onlus is an independent and neutral humanitarian organization. It was founded in Italy in 1994, to provide free high quality medical and surgical care to the victims of war, landmines and poverty. EMERGENCY also promotes a culture of solidarity, peace and respect for human rights. Over the years, EMERGENCY has been working in 16 countries, building and managing Medical and Surgical Centres, Rehabilitation and Social Reintegration Centres, Paediatric Clinics, First Aid Posts, Primary Health Clinics, a Maternity Centre and a Centre for Cardiac Surgery. EMERGENCY runs a new, 100-bed Ebola Treatment Center near the capital of Sierra Leone. Within the FILODIAG project, EMERGENCY will test the detection system under field conditions.
For more information please visit the website: www.emergency.it