GNA Biosolutions to present data on ultrafast plague test at Medical Biodefense Conference

Published on October 18, 2018.

GNA Biosolutions is engaged in an ongoing collaboration with the Bundeswehr Institute of Microbiology (the scientific center for biological medical biodefense of the German Armed Forces), Madagascar’s Ministry of Health, and the Institut Pasteur Madagascar. The partners aim to improve plague (Yersinia pestis) diagnostics in Madagascar (ENhancing Outbreak ResponSe CapacitiEs in Madagascar, ENdORSE).

 

The objectives of the ENdORSE project, as defined by a partners, are to strengthen plague diagnostics in the Malagasy reference laboratory; to implement a training capability for mobile diagnostics in a field laboratory, and the development of a molecular diagnostic system including portable instrumentation and a ultrafast test, which could be used to detect Yersinia pestis infection in remote outbreak locations in Madagascar. By quickly and reliably differentiating infected from non-infected patients, quarantine measures could be more targeted, plague transmission could be curbed, and unnecessary antibiotic therapies avoided.

 

Preliminary data for an ultrafast plague assay being developed on GNA’s proprietary Pulse Controlled Amplification (PCA) platform will be presented at the Medical Biodefense Conference to be held in Munich, Germany, from 28 to 31 October 2018. On-site assessment for future field tests in Madagascar are scheduled for November 2018.

 

 

ENdORSE Partners at the inaugural meeting, June 2018

 

GNA Biosolutions Announces Leadership Change

Published on October 12, 2018.

GNA Biosolutions announced today that Managing Director and CEO Dr. Frank Krieg-Schneider will be transitioning into an advisory role at the company, following the successful completion of strategic goals which enabled the launch of GNA’s first commercial platform for ultrafast molecular testing. Dr. Krieg-Schneider’s responsibilities as CEO are reverting to the founding team.

 

“It has been a great privilege to work alongside this highly skilled and enthusiastic team” said Dr. Krieg-Schneider. “Together we have taken a great journey that has brought GNA as a company to the next level. This is a company and a technology that will change the way we think about what is possible in molecular testing and I look forward to seeing the team’s continued success.”

 

Dr. Krieg-Schneider joined the GNA management team in 2016 with the mission to establish a commercialization strategy and to strengthen strategic industry partnerships. During his tenure, GNA launched a laboratory-use platform implementing the company’s proprietary Pulse Controlled Amplification (PCA) technology, the Pharos V8, as well as a Universal amplification kit. Building on this commercial experience, GNA will next bring to market a low-cost, Point-of-Care platform for molecular diagnostics with an infectious disease menu.

 

“We are grateful to Frank for his collaboration, leadership, focus, and dedication,” said Dr. Federico Bürsgens, co-founder and Managing Director. “Our work together serves as a strong foundation as we move forward to the next strategic phase and launch of our Point-of-Care system.”

GNA Biosolutions wins AACC’s Disruptive Technology Award

Published on August 6, 2018.

Chicago, Illinois, August 1, 2018: GNA Biosolutions was named the winner of the American Association of Clinical Chemistry’s (AACC) Disruptive Technology Award competition, held on Monday evening at the 70th AACC Annual Scientific Meeting & Clinical Lab Expo in Chicago, Illinois. The AACC Disruptive Technology Award recognizes innovative testing solutions that improve patient care through diagnostic performance or access to high-quality testing. GNA Biosolutions also won the audience choice award.

 

GNA presented data from the company’s proprietary Pulse Controlled Amplification (PCA) technology, which allows for ultrafast (15 minutes or less), sample-to-result workflows even on challenging clinical matrices such as whole blood. After launching a first PCA instrument (Pharos V8) at the end of 2017, GNA now plans to launch a portable and low-cost sample-to-result platform for infectious disease molecular testing at the Point of Care.

 

The planned assay pipeline for GNA’s CLIA-waivable POC platform focuses on antimicrobial-resistant pathogens that are highly relevant causes of hospital acquired infections, as well as multi-drug resistant tuberculosis (MDR-TB), an emerging challenge and risk for global health.

 

“We are honored to receive the Disruptive Technology Award from the AACC” said GNA Biosolutions co-founder and Managing Director Lars Ullerich. “Being recognized for our PCA technology is a proud moment for our whole team and we look forward to delivering it to the Point of Care.”

 

The company is also engaged in strategic partnerships to bring PCA-enabled ultrafast sample-to-answer workflows to applications across multiple industries. PCA is uniquely scalable from single-sample applications at the POC, to high-throughput applications in centralized laboratories.

 

About GNA Biosolutions: GNA Biosolutions is a molecular technology company based in Germany. Our breakthrough technology, Pulse Controlled Amplification (PCA), transforms molecular testing by combining ultrafast nucleic acid amplification with intrinsic sample prep, to enable powerful solutions for the laboratory, on-site applications and the Point of Care. Our vision is to bring the power of molecular testing, from sample to answer, to everyone, everywhere. For more information, visit: www.gna-bio.com

 

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Press contact: Anastasia Liapis, PhD

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GNA Biosolutions named finalist for AACC’s Inaugural Disruptive Technology Award

Published on July 27, 2018.

On July 30, 2018, GNA Biosolutions will be one of three finalists in the American Association of Clinical Chemistry’s (AACC) first-ever Disruptive Technology Award. GNA will be presenting data on the company’s proprietary Pulse Controlled Amplification (PCA) technology during a featured session at the 70th AACC Annual Scientific Meeting & Clinical Lab Expo. The AACC Disruptive Technology Award recognizes innovative testing solutions that improve patient care through diagnostic performance or access to high-quality testing.

 

GNA Biosolutions has demonstrated that PCA technology can detect dangerous pathogens within minutes in a variety of non-traditional laboratory settings such as field-hospitals, with the sensitivity and specificity of laboratory-based molecular diagnostics. GNA is currently developing an ultrafast (15 minutes or less), portable, low-cost integrated sample-to-result platform for infectious disease testing at the Point of Care (POC). The platform’s assay menu is currently planned to include Multidrug Resistant Tuberculosis (MDR-TB), Methicillin Resistant Staphylococcus Aureus (MRSA), and Multidrug-resistant Gram-negative bacteria (MDRGN).

 

The 70th AACC Annual Scientific Meeting is being held July 29-August 2 in Chicago, Illinois.

GNA Biosolutions to Showcase PCA Technology for Ultrafast PCR and Pharos V8 instrument at Analytica 2018

Published on April 9, 2018.

GNA Biosolutions GmbH will be showcasing the Pharos V8, the world’s first Laser PCR instrument based on the company’s proprietary Pulse Controlled Amplification (PCA) technology at the Analytica trade fair (Booth A3/522) in Munich, Germany from April 10-13. Launched in November 2017, the Pharos V8 delivers ultrafast PCR results in 10 minutes or less.

 

Conventional PCR platforms rely on bulky thermocyclers that limit the speed of the reaction. The Pharos V8 is the world’s first Laser PCR instrument powered by PCA, a novel patented technology developed by GNA Biosolutions.

 

Key features of PCA:

  • Unique patented technology for ultrafast nucleic acid amplification
  • Utilizes microcyclers in solution as miniature thermal hubs for the PCR reaction
  • Rapid energy pulses control speed, resulting in ultrafast PCR reaction times

Key features of the Pharos V8:

  • First commercially available Laser PCR instrument, based on PCA technology
  • Ultrafast PCR results in 10 minutes or less, on an easy to use interface
  • Universal DNA kit for lab-developed tests (bacterial, human genomic & viral DNA) in both single and multiplex formats

Lars Ullerich, Managing Director GNA Biosolutions states, “PCA is a completely unique and exciting approach to PCR that takes something fundamental and pushes it further. The Pharos V8 instrument delivers results with high sensitivity and unparalleled speed and makes PCR even more useful; it creates new possibilities for a range of different applications across multiple industries.”

 

In addition to the Pharos V8, GNA Biosolutions is implementing Laser PCR in an integrated sample-preparation system, as part of a consortium focused on MRSA detection (KAREL). The company also recently completed successful Laser PCR field tests for Ebola RNA virus detection in Sierra Leone as part of a publicly funded project (FILODIAG).

 

Multidisciplinary Consortium Announces Launch of PITBUL, an International Collaboration for the Development of Ultrafast Tuberculosis Diagnostics

Published on March 24, 2018.

Molecular testing for tuberculosis (TB) could one day take only a few minutes, according to scientists behind a new €3.8 million project.

 

Molecular technology company GNA Biosolutions GmbH and its project partners announced the launch of PITBUL, a European Commission funded international research project aimed at developing a tuberculosis (TB) diagnostic platform to be utilized at the Point of Care.

 

The PITBUL project includes international partners from academic institutions, hospitals, research institutes and companies, which will collaborate to develop an ultrafast test that can detect TB infection in minutes rather than hours, as with current molecular TB tests. Project partners include the Dodoma Regional Referral Hospital in Tanzania, the National Institute for Infectious diseases “L. Spallanzani” (based in Rome, Italy), the University of Latvia and the Riga East University Hospital, Fraunhofer IMM (Mainz, Germany), TATAA Biocenter, and MultiD Analyses AB (both in Göteborg, Sweden). GNA Biosolutions is serving as the project coordinator.

 

Traditional DNA tests for TB can take up to several hours to deliver a diagnosis. The PITBUL ultrafast TB test will be based on Pulse Controlled Amplification (PCA), a novel platform technology developed by GNA Biosolutions. The PITBUL ultrafast TB test aims to make DNA-based diagnosis of TB possible in just a few minutes. “Tuberculosis is a global public health threat, particularly with multi-drug resistant TB strains on the rise,” said GNA Biosolutions Managing Director Lars Ullerich. “We are excited to have a world -renowned team assembled so that together we can take on the challenge of making an extremely fast, cost-effective and easy-to-use TB test a reality.”

 

The European Commission’s Horizon 2020 program, the EU’s largest Research and Innovation program, has awarded PITBUL 3.8 million Euros for the duration of the project, which is expected to conclude in 2020. To commemorate this year’s World TB Day, the PITBUL team today launched a website which will provide additional details and news about this publicly funded research project. For more information, please visit www.pitbul-project.eu.

GNA Biosolutions Reveals New Ultrafast PCR Platform at Medica

Published on November 13, 2017.

Groundbreaking nucleic acid detection technology using nanomaterials

DUESSELDORF, Germany, November 13 – GNA Biosolutions GmbH, a molecular technology company based in Martinsried, Germany, today announced the launch of Pharos V8, the world’s first Laser PCR® platform. Pharos V8, an ultrafast PCR instrument for in vitro research use, will be showcased at the Medica Trade Fair (Exhibition Hall 3, Booth E93) from November 13-16.

 

The patented technology behind the Pharos V8 platform is Laser PCR®. Laser PCR® operates on the same principles as conventional nucleic acid amplification with PCR (Polymerase Chain Reaction). However, Laser PCR® uses nanomaterials to control temperature cycles at the nano scale, accelerating PCR reaction times by a factor of ten and opening the door for applications in multiple time-sensitive settings.

 

The Pharos V8 is the company’s first platform to come on the market, with additional product launches planned over the next two years. Key features of the Pharos V8 include:

  • An open platform for universal PCR assay development
  • Ultrafast real-time nucleic acid detection in 10 minutes or less
  • Intuitive interface with easy-to-use software that can be accessed remotely

Frank Krieg-Schneider, CEO of GNA Biosolutions states, “We are excited to present our first Laser PCR® platform, the Pharos V8, at this year’s Medica.  We believe the Pharos V8 will demonstrate the power of our patented technology to deliver ultrafast molecular results, and pave the way for additional platforms in development for diagnostic testing and point of care.”

 

About GNA Biosolutions:

GNA Biosolutions is a molecular technology company specializing in sample-to-result applications across medical diagnostics, biosecurity, food safety, and life sciences.

 

GNA Biosolutions develops instruments, OEM modules and applications for ultrafast molecular assays based on proprietary technology protected by a comprehensive patent portfolio.

GNA Biosolutions adds CEO to expand its management team

Published on July 5, 2016.

Munich, 05 July 2016 – GNA Biosolutions, Martinsried (Germany) has appointed Frank Krieg-Schneider as its Managing Director and CEO.

 

Frank is a senior executive in the diagnostics and life sciences industry with more than 20 years of experience in product development and commercialisation. After obtaining his PhD in molecular genetics from the University of Mainz, followed by a postdoctoral fellowship at the University Medical Centre Mannheim, Frank joined QIAGEN, a leading global provider of Life Science and Molecular Diagnostics products.

 

At QIAGEN, he was first instrumental in establishing the diagnostic sample preparation product range, and later in defining the strategy and product roadmap for the molecular diagnostics and point of care markets. In his former role as VP, Global Head of Strategic Alliances and OEM he successfully created new business opportunities for QIAGEN, such as the OEM business, Second Brands, and Customised Products. Frank managed independent businesses and employees across sites in Germany, Sweden and the United States. He drove revenues from zero to the high double-digit million USD range.

 

At GNA Biosolutions he is now expanding strategic alliances and promoting GNA’s commercialization. He will support GNA with his solid business experience, securing new OEM partnerships. This will allow the implementation of Laser PCR – GNA’s ultra-fast technology for molecular diagnostics – in selected partners’ applications and systems, in addition to GNA’s internal products.

 

He complements the existing management team, comprising the founders and co-Managing Directors Joachim Stehr, Federico Bürsgens and Lars Ullerich. The founders commented: “Frank is a perfect addition to our management team. He has a proven track record in building high-growth and profitable product portfolios.”  Frank Krieg-Schneider added: “I’m looking forward to break new ground with this strong team and our innovative technology, which applies the speed of light to PCR.”

Molecular diagnostics specialist GNA Biosolutions completes € 6 million (US$ 6.7m) financing round

Published on July 1, 2015.

Prepares for market entry with fast diagnostic instruments for hospital bugs

 

Munich (Germany), 1 July 2015 – GNA Biosolutions GmbH (GNA), a manufacturer of ultrafast pathogen diagnostic instruments, will receive fresh capital of € 6 million in a series B financing round. Founded in 2010, GNA welcomes new investors Robert Bosch Venture Capital (RBVC), SHS Gesellschaft für Beteiligungsmanagement GmbH, b-to-v Partners, and UnternehmerTUM-Fonds who are investing in its highly promising molecular diagnostics technology. The financing round was led by Robert Bosch Venture Capital. Existing shareholders include Mey Capital Matrix, KfW and the company’s founders.

 

Working with a laser-based PCR process, GNA facilitates reliable pathogen detection. The technology enables physicians and hospitals to diagnose bacterial diseases within minutes, with no need for time-consuming laboratory diagnostics. The specific DNA sequences for the pathogen under investigation are extracted and artificially multiplied (Polymerase Chain Reaction = PCR). The laser component of GNA’s technology is used for the necessary PCR thermo-cycling process (sample heating and cooling) and to read out results. Compared with traditional PCR diagnostics, this laser-based approach supplies results within just a few minutes. With low requirements in terms of sample preparation, it also facilitates the development of inexpensive diagnostics products.

 

GNA will use the funds from this financing round to bring its first product, the Pharos400 instrument, to market maturity. The Pharos400 processes samples with its integrated laser unit and allows a real-time detection and quantification of the results. Given its highly integrated diagnostics cartridges, Pharos400 will enable untrained hospital staff to quickly and easily obtain meaningful diagnoses. GNA will also work on developing tests for other hospital bugs. The company will focus above all on attracting university hospitals as its potential first customers.

 

Dr. Dieter Kraft, Investment Partner at Robert Bosch Venture Capital GmbH, comments: “With GNA Biosolutions, we are delighted to be supporting a company which operates at the interface between sophisticated mechatronic engineering and the growing global healthcare market, and one that has developed key innovations in this market.”

 

“PCR is now one of the fastest-growing areas of diagnostics. In recent years, the molecular diagnostics market has become a cornerstone for the world of medicine and beyond. GNA’s novel laser-based process enables physicians to treat patients faster, safely and more effectively– especially when it comes to time-critical diagnoses”, remarks Dr. André Zimmermann, Partner at the Tübingen-based growth financer SHS. Reinhilde Spatscheck, Managing Partner at SHS adds: “What convinced us is GNA’s innovative technological approach and the great potential this new PCR technology has for deployment. SHS is keen to invest in diagnostics applications that offer great growth potential.”

 

Comments Johan de Ruiter, Lead Investor at b-to-v Partners: “Multi-resistant bacteria present a significant problem in Germany, where between 400,000 and 600,000 treatment-related infections occur each year. Given the ultrafast availability of test results, the technology developed by GNA Biosolutions GmbH is particularly suited to applications in point-of-care diagnostics. Not only that, applications in other areas offer additional potential for marketing the technology.”

 

Andreas Unseld, Investment Manager at UnternehmerTUM Fonds, adds: “The efforts and initiatives currently underway in the political arena to improve hospital hygiene and get the problems associated with multi-resistant bacteria under control also require rapid, meaningful tests and diagnostic instruments capable of use, for example, in patient admissions. We see GNA as being ideally positioned to play a major role in the diagnostics market in future.”

 

In view of this financing round of great importance to GNA’s further development, the company’s management team – Drs. Lars Ullerich, Federico Bürsgens and Joachim Stehr – have issued the following statement: “We have already benefited from the business and industry expertise of this team of investors during the contract negotiation stage. With this financing round, we are now well positioned to jointly tackle the next key technological development steps and strategic decisions.”

 
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GNA Biosolutions leads consortium for ultra-fast detection of Ebola

Published on February 19, 2015.

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.

 

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