Germany-based molecular diagnostics company, GNA Biosolutions has closed a $13.5 million Series C round of financing backed by a U.S. and European Union (EU) consortium, with the money expected to advance the development and secure CE-IVD marking for the company’s first Point of Care (POC) molecular diagnostic platform.
GNA Biosolutions announced that the Series C financing round included new investors: GreyBird Ventures, Occident, and Wachtumsfonds Bayern. Existing investors are: SHS Gesellschaft für Beteiligungsmanagement, Robert Bosch Venture Capital, UVC Partners, Mey Capital Matrix, KfW, and btov Partners.
GNA eyes regulatory approval
The Genomeweb website explained that GNA had developed a PCR technology called pulsed control amplification (PCA) that rapidly regulates temperature with so-called microcyclers diffused in the master mix solution. PCA can be used to amplify nucleic acids directly from samples such as whole blood, sputum, and nasal swabs without additional sample preparation, the website said.
GNA further explained that its technology allows the development of cost effective and simple-to-perform molecular diagnostic tests. It’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 the Plague.
However, GNA’s PCA technology has not yet been cleared or approved by European or U.S. regulatory agencies. It is currently for research use only. The company expects that with the latest financing round, it can push for regulatory approval.
Federico Buersgens, GNA co-founder and Managing Director, said: “This Series C funding will help us execute our regulatory strategy and bring PCA to the clinic.”
Buersgens said having the backing of the U.S. and EU consortium gave GNA an edge, as this gave the company “a tremendous depth of experience but also visibility and access to decision makers across our key launch markets.”
GNA plans to launch its POC platform first in the EU, followed by the U.S.
Tom Miller, partner at GreyBird Ventures, lead investor for the round, said: “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.”
Following the financing round, Miller will now serve as the chairman of GNA’s board with immediate effect.
Crest of a wave
The completion of the Series C financing round caps a good past few months for GNA.
In June, the German startup was recognized as one of the 50 best-in-class startups across the medtech industry at the 2019 MedTech Innovator Showcase. Startups selected for this honor were given a slot in the MedTech Innovator Showcase in San Francisco in June. The company also has a slot at the Medtech Conference in Boston set for September.
“The MedTech Innovator competition is a unique and exciting opportunity for us to showcase our company and award-winning PCA technology. We are honored to be included amongst this group of innovative companies,” Anastasia Liapis, GNA head of strategic marketing and partnerships, said at the time.
In February, GNA announced that it had entered into a research collaboration with Boehringer Ingelheim that was focused on the development of a rapid African Swine Fever (ASF) diagnostic test. The test was to be used in combination with GNA’s portable molecular diagnostic platform, and is aimed at supporting the fight against the worldwide spread of ASF.
GNA co-founder and managing director, Lars Ullerich said the collaboration with Boehringer Ingelheim ”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.”
ASF, which does not affect humans, is a deadly viral pig infection with high mortality. It cannot be treated and there are no effective vaccines yet available. It is unclear how far ASF will spread, jeopardizing many countries’ pig trade and supplies.
More than 1 million pigs have been culled in China due to ASF outbreaks within the past few months. Russia has reported an ASF outbreak on its border with China.