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Genomtec Plans 2021 Launch for Handheld MDx Platform, Respiratory Disease Panel

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NEW YORK (360Dx) – Genomtec, a Polish molecular diagnostics company, is moving ahead with plans to debut a handheld testing device in the European clinical market by 2021, along with an accompanying panel for respiratory diseases.

The company recently received 9 million Polish złoty ($2.4 million) through Poland's National Center for Research and Development (NCBR) to support its activities. The funding was made through NCBR's fast track program for small and medium-sized enterprises. NCBR is an agency of the Polish Ministry of Science and Higher Education.

"This grant will enable us to enter mass production of our reaction cards, run clinical trials, and to develop additional assays," said CEO Miron Tokarski. "By 2021, we want to enter the market with a panel for respiratory viral infections."

The new fast track grant is just 70 percent of the funding necessary to achieve those aims. Tokarski noted that it must be matched by additional contributions from angel investors. "We are looking to raise about $1.5 million more from investors, ideally those with medical experience and with connections to distributors and potential partners," Tokarski said.

That financing combined should be able to support the firm as it transitions from developing a prototype of its system to having a CE-IVD-marked platform available for clinical use.

It's been a relatively quick evolution for the company, which Tokarski co-founded in 2016. Based in the city of Wrocław in western Poland, Genomtec currently employs 10, though it plans to add about seven more employees thanks to the new funding. These will include hires in the areas of laboratory medicine, microbiology, and operations as it begins to prepare itself for market entry.

The firm's core offering is a handheld diagnostic device called Genomtec ID. It supports the amplification and detection of both DNA and RNA fragments using Genomtec's isothermal nucleic acid amplification technology (INAAT), which has patents pending in Poland. The IP was developed solely by the company.

According to Genomtec, the approach includes the extraction of genetic material directly on the reaction card within a closed lab-on-chip analysis system. This means that users do not need to isolate genetic material elsewhere and minimizes the risk of sample contamination. It also means that essentially anyone can perform the assay, as it is fully automated within the device.

By carrying out the assay within the reaction card, the firm also claims it can improve detection, arguably making it possible to detect infections earlier, which in turn permits faster therapy selection. The INAAT approach uses eight oligonucleotide sequences to amplify the genetic material in a sample, versus the two oligos commonly used in PCR, the company notes. The assay also relies on "state-of-the-art enzymes" to specifically amplify a pathogens' DNA or RNA, shortening the amplification time to as little as 10 minutes, without requiring cycles of temperature changes. The entire turnaround time is about 20 minutes.

The company is positioning its platform as an alternative to current systems in the infectious disease market. Tokarksi declined to discuss specific content for the firm's debut respiratory viral panel, so it is difficult to ascertain against which panels it will compete.

However, Abbott's Abbott ID Now platform, an isothermal nucleic acid amplication system for detecting infectious diseases, could certainly be a competitor. Roche's Cobas Influenza A/B & RSV Test, which relies on multiplex, real-time PCR, could be another.

Genomtec's test will enjoy a relatively straightforward approach to market. Under the new European In Vitro Diagnostics Regulation (IVDR), the targets on Genomtec's panel actually do not require clinical trials for CE-IVD certification, and the panel does not require review by a notified body.

However, the company will still run clinical trials on its debut panel in order to build experience and data around the test prior to launch, Tokarski said.

"For these pathogens, the IVDR says you only need to perform clinical validation of your assay," he said. "But if you look at manuals of quantitative PCR diagnostics, you will see that they didn't perform clinical trials."

However, in many cases, those tests are giving false positive and false negative results, he claimed. "There is a difference between tests that have been optimized in clinical trials and those that have not been optimized."

This is the reason that Genomtec will run clinical trials for its tests, even if it doesn't have to, he noted, "to have the confidence that what we are offering will be delivered and will improve clinical outcome of patients."

While Tokarski did not elaborate on other assays in the pipeline for the Genomtec ID device, he said that the company plans tests for sepsis, tick-borne diseases, and sexually-transmitted diseases. These assays will require oversight from notified bodies under the new IVDR, he said.

While Genomtec has not provided a timeline for when those tests might reach the European clinical market, or the US market, it's clear that Genomtec plans to reach both following its platform commercialization in two years.

"From day one, we have been working with people who specialize in CE-IVD-marking and US Food and Drug Administration approval," Tokarski said, adding that the company will become ISO:13485 compliant next year to ensure its quality management systems are in place ahead of launch."We take control of all aspects of this assay," he noted.

In the future, Genomtec believes its platform might be particularly attractive to US physicians because it could potentially supply them with a new revenue stream. Tokarski noted that current CPT codes for multiplexing the targets in its respiratory panel offer a reimbursement rate of $87. However, the company will charge around $50 for the test, meaning that the difference between the reimbursement price and the cost of the assay will provide revenue for doctors.

"This way, we can convince them to transfer to this test," he said. "From our perspective, because the device will be cheaper than what is offered, with an estimated price of below $1,000, they will simply make a profit from making the test faster than competitive solutions that cost five or 10 times more." He did not name the rival offerings.

Reaching the US market, though, will require partnerships that the company needs to secure.

"We are looking for partnerships," Tokarski said. "For startups, making sales directly to clients is something huge. From this perspective, we will be working with distributors and the distributors would work with the clients," he said. "There are exceptions for this, though," he added. "If we can sign a deal with bigger players, we can sell directly to them."