GNA Biosolutions Closes $13.5M Series C Financing Round Backed by a US/EU consortium

Published on August 5, 2019.

Funding will finance further development and IVD-CE marking of the company’s first molecular POC (Point of Care) platform, based on Pulse Controlled Amplification (PCA) technology


Munich, Germany, August 5, 2019 – GNA Biosolutions GmbH, a molecular diagnostics company based in Germany, announced today that it has completed a $13.5M round of financing.


The Series C financing round was joined by new investors including GreyBird Ventures, Occident, and Wachtumsfonds Bayern, and existing investors SHS Gesellschaft für Beteiligungsmanagement, Robert Bosch Venture Capital, UVC Partners, Mey Capital Matrix, KfW, and btov Partners. Proceeds from the financing will be used to advance development and secure IVD-CE marking of GNA’s first Point of Care molecular diagnostic platform.


GNA Biosolutions has pioneered a next generation nucleic acid amplification technology (Pulse Controlled Amplification – PCA) in the field of molecular diagnostics. The company’s PCA platform amplifies nucleic acids captured directly from complex samples such as whole blood, sputum, and nasal swabs within minutes, without the need for additional sample preparation and with minimal hands-on time.


“We are excited to work with the GNA team and look forward to supporting this stage of the company. Rapid molecular diagnostics are key to patient care across an increasingly broad range of therapeutic areas, and particularly infectious diseases. We believe PCA technology will resolve many limitations of existing molecular diagnostics, enabling fast therapeutic decisions that improve patient care,” said Tom Miller, partner at GreyBird Ventures, lead investor for the round. Mr. Miller, a global healthcare industry leader and an experienced and visionary CEO, will serve as Chairman of GNA’s Board effective immediately. 


“We are very appreciative of the enthusiastic response from our new investors and the continued support of our existing consortium. This Series C funding will help us execute our regulatory strategy and bring PCA to the clinic,” said Federico Buersgens, co-founder and Managing Director of GNA Biosolutions.  GNA plans to launch its POC platform first in the EU, followed by the US. “We believe having this unique combination of European and US investors on board gives GNA an edge – we have assembled a great consortium which will provide us not only with a tremendous depth of experience but also visibility and access to decision makers across our key launch markets” said Mr. Buersgens.


GNA’s breakthrough technology allows the development of cost effective and simple-to-perform molecular diagnostic tests. The company’s prototype platform has been utilized in more than 30 assays in-house and with partners, including assays for Hospital Acquired Infections and Tuberculosis, and biothreats such as Ebola and Plague.


GNA is the winner of AACC’s 2018 Disruptive Technology Award and a Showcase Company in the 2019 MedTech Innovator Competition.


About GNA Biosolutions

GNA Biosolutions is a private molecular diagnostics company located in Germany. Our proprietary PCA technology offers a novel, ultrafast, and cost-effective molecular diagnostic platform that captures and amplifies nucleic acids from complex clinical samples. PCA assays are being developed for a number of therapeutic areas, including infectious diseases and biothreats.


The company’s first Point of Care product will be utilized for the diagnosis of antibiotic resistant Hospital Acquired Infections (HAIs) and Tuberculosis (TB). PCA technology has not been cleared or approved by European of U.S. regulatory agencies and is currently for research use only.


For more information, please visit www.gna-bio.com


Contacts

GNA Biosolutions GmbH
Anastasia Liapis – Head of Strategic Marketing & Partnerships

GNA Biosolutions Among World’s Best-in-class Startups Featured in 2019 MedTech Innovator Showcase

Published on June 18, 2019.

June 18, 2019 – GNA Biosolutions has been awarded a place in the 2019 MedTech Innovator Showcase, which features leading-edge device, diagnostic, and digital health technologies from around the world.


Each year, MedTech Innovator recognizes the 50 best-in-class startups across the medtech industry. Startups selected for this honor receive a slot in the MedTech Innovator Showcase.


This year’s competition attracted a record-breaking number of applications, with more than 800 companies applying. Applications were reviewed by more than 150 executives and professionals from dozens of leading companies including Johnson & Johnson, RCT Ventures, Baxter, BTG, HOYA Corp, NIPRO Medical Corp., Olympus Medical Systems Group, W.L Gore & Associates, Inc. and many more.


MedTech Innovator is a premier nonprofit startup accelerator in the medical technology industry. MedTech Innovator’s 2019 program includes participation from the U.S. military, National Institutes of Health (NIH), Food and Drug Administration (FDA), and Biomedical Advanced Research and Development Authority (BARDA), as well as leading healthcare investors, manufacturers, providers, hospital systems, and payers.


As part of the program, GNA Biosolutions will be presenting at the MedTech Innovator Showcase held in conjunction with The Wilson Sonsini Goodrich & Rosati Medical Device Conference taking place June 20-21 in San Francisco, and The MedTech Conference on Sept. 23-25 in Boston.  


“The MedTech Innovator competition is a unique and exciting opportunity for us showcase our company and award-winning PCA technology,” said Anastasia Liapis, Head of Strategic Marketing & Partnerships at GNA Biosolutions. “We are honored to be included amongst this group of innovative companies.”

GNA Biosolutions and Boehringer Ingelheim Partner on Emergency Veterinary Diagnostics Development

Published on February 26, 2019.

Program could lead to new diagnostic solutions for African Swine Fever (ASF) worldwide

 

GNA Biosolutions and Boehringer Ingelheim announce that the companies have entered into a research collaboration focused on the development of a rapid African Swine Fever (ASF) diagnostic test. The test would be used in combination with GNA’s portable molecular diagnostic platform, and is aimed at supporting the fight against the worldwide spread of this deadly disease.

 

ASF is a devastating viral infection of swine causing severe clinical disease and high mortality. The disease cannot be treated and currently no effective vaccines are available. ASF does not affect humans. It is currently unclear how far ASF will spread, jeopardizing many countries’ pig trade and supplies. Due to ASF outbreaks, more than 600,000 pigs were culled within the past few months in China alone.

 

“We are delighted to enter this collaboration with Boehringer Ingelheim, a global leader in animal health. This collaboration further emphasizes the role of GNA Biosolutions in the rapidly developing field of extra-laboratory diagnostics and extends the application of our Pulse Controlled Amplification (PCA) technology into animal protection,” said GNA Biosolutions co-founder and Managing Director, Dr. Lars Ullerich.

 

“Together with GNA we are striving to develop holistic solutions for veterinarians, farmers and the food producing industry. The targeted platform will allow for faster decision making based on more comprehensive diagnostic data,” shared the Global Head of Diagnostics & Monitoring Animal Health at Boehringer Ingelheim, Rolf-Dieter Günther.

 

Financial details of the agreement were not disclosed.

 

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GNA Biosolutions to Present at MedTech Showcase 2019 in San Francisco

Published on January 4, 2019.

Dr. Federico Buersgens, co-founder and CFO of GNA Biosolutions, will present at MedTech Showcase 2019, to be held January 7-9 during JP Morgan healthcare conference. The schedule is as follows:

 

Date:  Tuesday, January 8, 2019

Time:  11:15 AM Pacific Time

Location:  Parc 55 San Francisco Union Square, 55 Cyril Magnin Street, Powell II (Level 3)

 

“We have developed an ultrafast sample-to-result molecular diagnostics technology, suitable even for very challenging samples, and scalable from single sample testing near the patient to high-throughput in the lab. Our Pulse Controlled Amplification (PCA) technology can eventually be integrated on a USB stick” said Dr. Buersgens.

 

“We are delighted that GNA will be presenting at MedTech Showcase this year,” said Dr. Lars Ullerich, co-founder and COO of GNA Biosolutions.  “The conference is the perfect forum for us to showcase our award-winning technology and expand our partnerships with life sciences and health technology companies. We look forward to a great opportunity to foster new collaborations.”

 

The GNA team including Dr. Buersgens (), Dr. Ullerich () and Head of Strategic Marketing & Partnerships Dr. Anastasia Liapis (), will also be available to hold one-on-one meetings with corporate partners and investors.

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

Phone number: +49(0)89 998207 195

Email:

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.