Germany’s GNA Biosolutions Commercializing Rapid MDx Instrument, SARS-CoV-2 Test

Source: GenomeWeb, Author: Madeleine Johnson

NEW YORK – With recent regulatory approval in Germany, GNA Biosolutions has begun commercializing a rapid, moderate-throughput, sample-to-answer molecular diagnostics instrument called Octea along with an assay for SARS-CoV-2. 

The Munich-based firm also is using support from the Innovative Medicines Initiative (IMI) to develop its technology into a disposable molecular diagnostics system, which it expects to be a pioneer in instrument-free home-use molecular testing. 

GNA Biosolutions received Emergency Use Authorization from the German Federal Institute for Drugs and Medical Devices for its SARS-CoV-2 test on the Octea instrument late last year. 

The Octea tests eight samples simultaneously, while the firm’s SARS-CoV-2 test on the Octea specifically detects the E-gene of the virus from oropharyngeal swabs. The assay has a total sample-to-result time of 45 minutes, which includes a 25-minute extraction step. Test kits come with all necessary reagents, including proprietary bead-based extraction, such that users do not need to purchase separate sample prep reagents. 

GNA Biosolutions CEO Federico Buersgens said in an interview that the firm has already received a subscription right for 1 million tests from the free state of Bavaria and has also had several hundred requests for the system so far. 

Specifically, the Bavarian Ministry of Economic Affairs invested in accelerating development of the system in 2020 and has already ordered a first batch or 60,000 tests. The firm also is working with Bavaria to place systems in pilot sites as a first step in its roll out, including in clinical settings and workplace testing sites. 

GNA Biosolutions originally spun out from the Institute for Photonics and Optoelectronics of the Ludwig Maximilian University of Munich in 2010 and has consistently targeted its core technology — called pulsed control amplification (PCA) — for infectious disease diagnostics use. 

Its first system was the Pharos 400, followed by the Pharos V8. While these previous iterations of the PCA technology used lasers, the heating and cooling in the Octea is accomplished using electrical heating of thin foils, Buersgens said. 

“We think we have an even more attractive product now, which is particularly well suited for SARS-CoV-2 diagnostics,” he said, adding that it is “much more robust, compact, and affordable.” 

The core technology involves essentially levitating magnetic bead-bound samples near the sides of a reaction vessel, where they can be rapidly thermal cycled using localized temperature pulses.

GNA Biosolutions claims four-second ramp times for its Octea thermal cycling, in part because it does not need to heat the entire 40 microliter reaction volume in the tube. And, the PCA process can be run in a compact instrument using a battery because it does not require as much energy as standard thermal cycling, Buersgens said.

In addition, “We do not rely on any kind of exotic chemistries or enzymes,” he said, but rather the technology works with standard PCR chemistries, such as TaqMan.

“We are a spinout of a physics department, and it has always been part of our corporate DNA to use physical methods to improve DNA analytics and molecular diagnostics,” Buersgens explained.

The list price of the Octea is €12,500 (US$15,206), and the firm is targeting a cost per test of below €20.

GNA Biosolutions anticipates publishing clinical study data for the Octea and SARS-CoV-2 test in the next few weeks, Buersgens said. In the study, the firm found that the test’s performance was “substantially better” than half a dozen antigen tests and comparable to two different lab-based PCR assays.

Its limit of detection of below 1,000 viral copies per milliliter is in the range of some of the best-performing PCR tests, Buersgens added.

The Octea system is a rapid sample-to-answer instrument, but Buersgens noted that it is not CLIA-waivable in the current manifestation. That said, it is also not the kind of system that has to be used in a central lab, either.

The firm is targeting a use space for Octea somewhere between a central lab and the point-of-care, ideally for settings that need to test a few dozen samples per day, such as clinical labs or temporary COVID-19rapid test sites in airports or other decentralized spaces.

GNA raised $13.5 million in Series C funding in 2019 to support development of the Octea system. The firm now expects to obtain CE-IVD for the Octea and the SARS-CoV-2 test by the end of the first quarter, and is looking into entering the US market as well, Buersgens said.

Anastasia Liapis, vice-president of strategic marketing and partnerships at GNA Biosolutions, confirmed that the Octea will replace the Pharos laser-based systems, and said that the firm is now working with established manufacturing partners in Germany and has invested in manufacturing lines and reagents to enable rapid scale up for the system. It currently has double-digit weekly manufacturing capabilities, she said.

In addition to Octea, GNA is developing an instrument-free test system that will be for point-of-care and home use.

The firm was selected as one of eight projects from among 144 applicants to an Innovative MedicinesInitiative (IMI) call for proposals last year and will share in a total funding amount of €72 million. As part of the IMI support, GNA Biosolutions will partner with groups in Germany, Italy, and Spain on a project called Decision, with the overall aim of developing a low-cost, miniature, disposable COVID-19 molecular test that will run in 15 minutes.

Liapis said the system uses the same technology as Octea, and with its consortium partners, GNABiosolutions has already advanced the microfluidics concepts for the project.

The home-use infectious disease diagnostics space seems likely to grow due to the COVID-19 pandemic, with the US Food and Drug Administration encouraging more at-home test EUA submissions. It authorized a fully at-home molecular test from Lucira in November of last year, as well as an over-the-counter fully at-home rapid antigen test from Ellume and an at-home indication for the Abbott BinaxNow test. In addition, Quidel recently described plans to enter the nascent over-the-counter infectious disease testing market with its QuickVue antigen test, as well as potentially with a dedicated instrument on which consumers could run their own immunoassays.

Other small instrument or instrument-free molecular diagnostics in development include ones using paper, smartphones, and loop-mediated isothermal amplification (LAMP). The latter method is being developed by Detect, for example. Startup Sense Biodetection uses a different proprietary isothermal method, and newcomer Nuclein relies on true PCR performed in a disposable handheld instrument. SherlockBiosciences, meanwhile, was recently awarded $5 million from the Bill and Melinda Gates Foundation to support an instrument-free test using Internal Splint-Pairing Expression Cassette Translation Reactiontechnology.

At-home infectious disease testing also needs to have connectivity for cases in which the particular illness requires reporting to public health agencies. Liapis said that connectivity will likely be a key differentiator for”all the companies that are rushing toward the home market for molecular,” and noted that this is a very important part of GNA Biosolutions’ product development.

Overall, the SARS-COV-2 pandemic has given the global community a glimpse into the importance of high-quality diagnostics like molecular testing, and also stimulated the growing trend toward home-use testing, Buersgens said.

True PCR is generally considered to be the most sensitive testing technology, and low-cost, instrument-free tests will likely have an advantage with consumers. So, while the idea of bringing molecular testing into the home may have been around for some time, “There are very few technologies that can deliver on the promise,” Buersgens said, adding, “We think that we have one of them.”

GNA Biosolutions erhält Sonderzulassung vom Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) für das molekulare SARS-CoV-2-Schnelltestsystem

MÜNCHEN, 29. Dezember 2020 — Das deutsche Molekulardiagnostik-Startup GNA Biosolutions hat vom Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) eine Sonderzulassung für das GNA Octea SARS-CoV-2-Testsystem erhalten. Mit der neuen Technologie von GNA Biosolutions lassen sich dezentrale Corona-Schnelltests in etwa 40 Minuten durchführen ohne Abstriche bei der Genauigkeit zu machen. 

Das System besteht aus dem tragbaren Analysator GNA Octea und einem SARS-CoV-2-Testkit und dient dem schnellen molekularen Nachweis des SARS-CoV-2-Virus aus oropharyngealen Abstrichen. Das GNA Octea SARS-CoV-2-Testsystem basiert auf der Pulse Controlled Amplification (PCA®)-Technologie, einem proprietären neuen Ansatz für die Polymerase-Kettenreaktion (PCR), dem globalen Goldstandard für molekulare COVID-19-Tests.

Die meisten empfindlichen molekularen COVID-19 PCR-Tests werden in zentralisierten Labors durchgeführt, die auf die Probenentnahme an diversen Standorten und auf den Transport ins Labor angewiesen sind – ein Prozess, der bis zu 48 Stunden dauern kann und die Identifizierung infizierter Patienten – und damit die Unterbrechung von Infektionsketten – verzögern kann. Darüber hinaus handelt es sich bei den meisten Corona-Schnelltests um Antigen-Tests, die nicht die Genauigkeit der Testergebnisse von molekularen Tests aufweisen und zu falsch-negativen oder falsch-positiven Ergebnissen führen können (1).

Das Octea SARS-CoV-2-Testsystem von GNA ermöglicht molekulare  Corona-Schnelltests in dezentralen Labors mit hoher Sensitivität:

  • Flexible Einsatzmöglichkeiten: Das Testgerät kann aufgrund seiner Größe und seines Gewichts (<2 Kilogramm) mobil eingesetzt werden, in dezentralen Labors, mobilen Labors und Zeltlabors. Damit spart man wertvolle Zeit, die nicht für den Transport der Probe in ein zentrales Labor benötigt wird. 
  • Genauigkeit: Die PCA-Technologie von GNA Biosolutions weist eine hohe Sensitivität (96,7 Prozent) beim Nachweis viraler Nukleinsäuren auf, vergleichbar mit dem Goldstandard in der Industrie, PCR-Systemen. 
  • Integriertes Testkit: Pro Analyselauf können bis zu acht Patienten-Proben untersucht werden, ohne dass zusätzliche Reagenzien oder komplexe Geräte zur Probenextraktion benötigt würden.
  • Geschwindigkeit: GNA Biosolutions reduziert die Durchlaufzeit auf ca. 40 Minuten – von der Probenentnahme bis der Patient das Testergebnis erhält 

„In unserem Kampf gegen die Corona-Pandemie können wir das Gesundheitswesen ab sofort mit unserem innovativen Schnelltestsystem unterstützen. Unsere Technologie ermöglicht eine schnelle und sehr genaue Diagnose von COVID-19 in dezentralisierten Labors hier in Bayern und Deutschland. Die Sonderzulassung durch das BfArM öffnet uns nun die Tür, um die Gesellschaft zu unterstützen, in der wir leben und arbeiten”, sagte Dr. Federico Buersgens, Mitgründer und CEO von GNA Biosolutions. „Damit wir unsere Technologie europaweit zur Verfügung stellen können, streben wir eine CE-Markierung im ersten Quartal 2021 an.”

Um die Entwicklung des GNA Octea SARS-CoV-2-Testsystems von GNA Biosolutions zu beschleunigen, hat das Startup im April 2020 eine Förderung durch das Bayerische Wirtschaftsministerium erhalten. GNA Biosolutions arbeitet mit bayerischen Produktionspartnern zusammen und hat in Instrumente, Verbrauchsmaterialien und Reagenzien investiert, um die Produktion von mehr als 500.000 Tests zu gewährleisten. 

„Es ist einer sensationellen Leistung unseres gesamten Teams zu verdanken, dass wir die Entwicklung und Zulassung in nur wenigen Monaten abschließen konnten. Ohne ihre Expertise, ihren unermüdlichen Einsatz und ihre großartige Zusammenarbeit wäre das nicht möglich gewesen. Unser Dank gilt aber auch unseren Fertigungspartnern und dem Bayerischen Wirtschaftsministerium, die entscheidend dazu beigetragen haben, dass wir diese Technologie in die Realität umsetzen konnten. Unsere Technologie bietet eine einzigartige, einfache und effektive Möglichkeit für schnelle molekulare Tests in dezentralen Labors. Wir freuen uns darauf, mit den lokalen Gesundheitsbehörden und dem Bundesministerium für Gesundheit zusammenzuarbeiten, um das GNA Octea SARS-CoV-2-Testsystem auf den Markt zu bringen und den Bedarf an molekularen Corona-Schnelltests zu decken”, so Dr. Buersgens.

Weitere Informationen über das GNA Octea SARS-CoV-2 Testsystem finden Sie unter 

(1) Fitzpatrick MC, Pandey A, Wells CR, Sah P, Galvani AP. Buyer beware: inflated claims of sensitivity for rapid COVID-19 tests. Lancet. 2020 Dec 14:S0140-6736(20)32635-0. doi: 10.1016/S0140-6736(20)32635-0. Epub ahead of print. PMID: 33333002.

Über GNA Biosolutions 

Die GNA Biosolutions GmbH ist ein molekulardiagnostisches Unternehmen, das 2010 in Martinsried gegründet wurde. Die Kerntechnologie von GNA, die sogenannte Pulse Controlled Amplification (PCA®), ist ein neuer Ansatz für die molekulare Goldstandard-Technologie, die Polymerase-Kettenreaktion (PCR), die  aber schneller ist und für die Herstellung kleiner, tragbarer und energieeffizienter Geräte verwendet werden kann. 

Über das GNA Octea SARS-CoV-2 Testsystem

Das GNA Octea SARS-CoV-2 Testsystem führt den qualitativen Nachweis von Nukleinsäure des SARS-CoV-2-Virus in oropharyngealen Abstrichen. Das GNA Octea Molekulartestsystem und das SARS-Cov-2 Testkit sind nur für die Verwendung durch geschultes klinisches Laborpersonal vorgesehen

Für weitere Informationen besuchen Sie: 


Anastasia Liapis, PhD
VP, Strategic Marketing & Partnerships

GNA Biosolutions Receives Emergency Use Authorization from German Health Authority BfArM for Rapid Molecular SARS-CoV-2 Batch Testing System

MUNICH, December 29, 2020 – German molecular diagnostics startup GNA Biosolutions has received Emergency Use Authorization (Sonderzulassung) from the German Federal Institute for Drugs and Medical Devices (BfArM) for the GNA Octea SARS-CoV-2 Test System. The new technology developed by GNA Biosolutions enables decentralized COVID-19 rapid tests in approximately 40 minutes without sacrificing sensitivity. 

The GNA Octea SARS-CoV-2 Test System is based on Pulse Controlled Amplification (PCA®) technology, a proprietary new approach to Polymerase Chain Reaction (PCR), the gold standard technology used globally in molecular COVID-19 testing. The system is comprised of the GNA Octea portable analyzer and a SARS-CoV-2 test kit and performs rapid molecular detection of the SARS-CoV-2 virus from oropharyngeal swabs.

The most sensitive molecular COVID-19 PCR testing is conducted in centralized laboratories which rely on sample collection across various sites and transport back to the laboratory for analysis – a process that may take up to 48 hours to complete and which could delay identification of infected patients. Furthermore, the majority of rapid tests for COVID-19 are antigen tests, which have not demonstrated the sensitivity of molecular tests, and may lead to false negatives and or missed infections (1).

GNA’s Octea SARS-CoV-2 Test System addresses an unmet need for rapid and sensitive decentralized testing for COVID-19 with several unique features:

  • Flexibility: A portable analyzer which weighs less than 2kg and is small enough to be used on-site in decentralized laboratories, mobile laboratories, and tent labs. Thereby, valuable time is not wasted by transporting the sample to a central laboratory 
  • Accuracy: Sensitivity of 96.7% for detecting viral nucleic acids, which is comparable to gold standard PCR analyzers
  • All-in-one test kit: Testing of one to eight samples per analyzer run, without the need for additional reagents or sample complex extraction instruments
  • Speed: With GNA’s technology turnaround time is significantly reduced to approximately 40 minutes from sample to result

“We are committed to supporting the fight against the COVID-19 pandemic by bringing our innovative rapid molecular batch testing system to the health care community. Our GNA Octea SARS-CoV-2 Test System can uniquely enable molecular diagnosis of COVID-19 in decentralized labs here in Bavaria and across Germany. This BfArM approval opens the door for us to support the communities where we live and work,” said Dr. Federico Buersgens, GNA Biosolutions’ co-founder and CEO. “Our next step will be to obtain CE marking for the GNA Octea SARS-CoV-2 Test System in the first quarter of 2021, to expand our reach across Europe.”

GNA Biosolutions received support to accelerate development of the GNA Octea SARS-CoV-2 Test System in April of 2020 through the Bavarian Ministry of Economic Affairs. GNA Biosolutions has worked with Bavarian manufacturing partners and invested in capacity for instruments, consumables, and reagents to guarantee production of more than 500k tests. 

“It is a tremendous accomplishment for our team to complete development and approval in just a few months – it would not have been possible without our team’s expertise, their tireless commitment and great collaboration. We are also thankful to our manufacturing partners, and the Bavarian Ministry of Economic Affairs, which were all critical to making this system a reality. Our technology provides a unique, simple, and effective way to enable rapid molecular testing in decentralized laboratories. We look forward to working with local health authorities and the Federal Ministry of Health to bring the GNA Octea SARS-CoV-2 Test System to market and fulfill the ongoing unmet need for rapid molecular COVID-19 testing” said Dr. Buersgens.

More information about the GNA Octea SARS-CoV-2 Test System is available at 

(1) Fitzpatrick MC, Pandey A, Wells CR, Sah P, Galvani AP. Buyer beware: inflated claims of sensitivity for rapid COVID-19 tests. Lancet. 2020 Dec 14:S0140-6736(20)32635-0. doi: 10.1016/S0140-6736(20)32635-0. Epub ahead of print. PMID: 33333002.

About GNA Biosolutions 

GNA Biosolutions GmbH is a molecular diagnostics company founded in Martinsried, Germany in 2010. GNA’s core technology, called Pulse Controlled Amplification (PCA®), is a new approach to the molecular gold standard technology, polymerase chain reaction (PCR), but works faster and can be used to produce small, portable, energy-efficient instruments. 

About the GNA Octea SARS-CoV-2 Test System

The GNA Octea SARS-CoV-2 Test System performs qualitative detection of nucleic acid from the SARS-CoV-2 virus in oropharyngeal swabs. The GNA Octea molecular test system and SARS-Cov-2 test kit is intended for use by trained clinical laboratory personnel only.

For more information, visit:


Anastasia Liapis, PhD
VP, Strategic Marketing & Partnerships