Blue DNA double helix on top of a print out of genetic sequence letters (black on a white background) to indicate genome sequencing carried out as part of the Estonian Biobank precision medicine project.
Credit: Mopic/Fotolia.com

GNA Biosolutions GmbH, a molecular diagnostics company based in Germany, has completed a $13.5-million round of financing. The new funding will finance further development and IVD-CE marking of the company’s first molecular point of care (POC) platform, which is based on its Pulse Controlled Amplification (PCA) technology.

PCA is a novel molecular diagnostic platform that captures and amplifies nucleic acids from complex clinical samples. The company says it is faster, simpler to use, and less expensive than current technologies.

The Series C financing round was joined by new investors including GreyBird Ventures, Occident, and Wachstumsfonds Bayern, as well as existing investors SHS Gesellschaft für BeteiligungsmanagementRobert Bosch Venture Capital, UVC Partners, Mey Capital Matrix, KfW Group, and btov Partners.

“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, in a release. Miller will serve as chairman of GNA’s board, effective immediately.

GNA is developing PCA assays for a number of therapeutic areas, including infectious diseases and biothreats, such as Ebola and plague. The company’s prototype platform has been used in more than 30 assays in-house and with partners. Its first POC product will be used to diagnose antibiotic-resistant hospital-acquired infections and tuberculosis.

According to the company, PCA has several advantages over competing technologies. For example: whereas steps in conventional molecular testing involve discreet lysis, sample purification, and amplification using complex reagents, PCA has an intrinsic target capture capability for nucleic acid purification, which makes going from sample to answer simpler.

Moreover, conventional PCR amplification reactions must cycle through different temperatures, which requires thermal cyclers and fans be built into the instrument. In PCA, those thermocyclers are replaced by microcyclers in the consumable: Microsecond pulses mediate instantaneous heating, enable passive cooling, and allow detection of amplified nucleic acids in 10 minutes or less.

Finally, the company says its technology will save costs because PCA-based instruments can be made with low-cost, mass-produced, ready-to-assemble components. Furthermore, PCA technology is scalable from high throughput to single test chips and portable battery-operated instruments.

GNA was founded in 2010, launching its first product seven years later—Pharos V8, an ultrafast PCR research-use instrument that uses the company’s proprietary Laser PCR technology.

“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, GNA’s co-founder and managing director.

GNA plans to launch its POC platform first in the EU, followed by the United States. “We believe having this unique combination of European and U.S. 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 Buersgens.

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