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-19 rapid 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 Medicines Initiative (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, GNA Biosolutions 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. Sherlock Biosciences, 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 Reaction technology.
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."