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SARS-CoV-2 Testing Boosts EliTech Assay, Instrument Sales

NEW YORK – Spurred by pandemic-related diagnostic testing demand, EliTech has increased placements of its sample-to-answer molecular diagnostic instruments. The Paris, France-based firm intends to use SARS-CoV-2 testing as a toehold to expand further in the hospital lab market going forward.

Called the Elite InGenius, the EliTech platform was first described by the firm in 2015. It is a fully automated, mid-throughput instrument that uses 12 separate thermal cyclers to test a dozen samples in 2.5 hours. The system has extraction capabilities to support testing a diversity of specimen types, and it can run EliTech assays as well as laboratory-developed tests.  

Christoph Gauer, CEO of EliTech Group, said in an interview that the pandemic has impacted EliTech in a number of ways.

First, "It has accelerated our business tremendously — our sales have increased many times over compared to the previous year, and we are really fortunate to be able to help fight the pandemic," he said.

The firm was one of the first to receive Emergency Use Authorization from the US Food and Drug Administration for a SARS-CoV-2 assay. In partnership with South Korea's OsangHealthcare, EliTech was granted EUA on March 4 for a test kit that can run on its InGenius platform. The test is called the GeneFinder COVID-19 Plus RealAmp Kit and is authorized for use with nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens.

EliTech also validated and submitted its own COVID-19 molecular diagnostic test for EUA three months ago and is selling it in the US in accordance with current FDA guidelines, Gauer said.

Worldwide, the firm has distributed more than 3.5 million SARS-CoV-2 tests to date.

"We are now working on a COVID/flu combo that we will submit to the FDA for EUA, as well," Gauer said.

EliTech has also installed more than 500 instruments worldwide, roughly 100 of which were placed after the SARS-CoV-2 pandemic began.

Many of the new sales were customers that the firm had talked to before but who had not yet made the commitment to purchase a system, Gauer said.

Typically, "If somebody is mulling over a new instrument and trying to get a budget, that can take a year, sometimes even more," he said. "COVID accelerated this from a year to about two weeks."

Customers have also expanded from running testing in a single shift to operating the lab around the clock.

The InGenius was cleared by the US Food and Drug Administration in late 2018 along with an assay to detect and distinguish herpes simplex viruses 1 and 2. The firm initially targeted the transplant market and has since branched into infectious disease testing. The InGenius test menu now covers gastrointestinal and respiratory testing and meningitis, and overall, the firm makes about 40 assays that have CE-IVD mark, many to detect viral infections in the transplant patients.

Surprisingly, the transplant lab testing space during the pandemic has been "remarkably resilient," Gauer said, as life-saving operations have continued. Indeed, some customers have begun sending out transplant tests to make room on the InGenius for SARS-CoV-2 testing, since COVID results are more time critical, he said.

The firm now has plans to fill the remaining holes in the menu, namely HIV and hepatitis. "By mid-next year we will have what I would call a complete CE-IVD menu in infectious disease," Gauer said.

In addition to the HSV 1 and 2 test in the US, EliTech previously obtained EUA for a Zika test and has a methicillin-resistant Staph aureus test cleared to run on another thermal cycler.

Gauer noted that EliTech is now working on two FDA approvals for 2021, but he declined to comment on the specific targets of the tests at this time.

The firm's SARS-CoV-2 test was used as the reference method in an evaluation of an assay from Seegene, as reported in the European Journal of Clinical Microbiology & Infectious Diseases.

The system, along with a research-use only macrolide-resistant Mycoplasma pneumoniae test, were also evaluated recently, as described in the Journal of Clinical Microbiology. Consistent with a previous evaluation, the EliTech Elite InGenius Mycoplasma MGB research-use-only (RUO) PCR test showed high sensitivity, and was found to be more sensitive than other commercial tests, including Meridian Bioscience's Alethia Mycoplasma Direct, GenMark Diagnostics' ePlex respiratory pathogen panel, Luminex's NxTAG RPP, and SpeeDx's Resistance Plus MP assays.

The company has also published an evaluation of an assay for macrolide-resistant Mycoplasma genitalium, a type of sexually transmitted infection that is of growing concern. That assay is distributed in the US by Hardy Diagnostics.

Gauer said the firm had made very good progress in the US in the transplant world, but "With the advent of COVID, that changed dramatically," as other new opportunities have opened up, as well.

The company has now been successful in placing systems for COVID-19 testing, but continues to focus on the hospital space, so that labs will have use for the system once the pandemic ends, Gauer said.

In terms of costs, the InGenius instrument is roughly $130,000 and the assays are approximately $60, but "pricing is very regional," Gauer noted.

Ben Goodstein, vice president and chief ambulatory officer at Dayton Children’s Hospital, said in an email that his team began adopting the EliTech system in early April for genetic and respiratory infectious disease panel testing.

He said that prior to then, the hospital had one of the systems. It now has nine. The lab is currently using these instruments to run approximately 700 SARS-CoV-2 tests per day.

The hospital purchased the InGenius primarily to help with testing for COVID-19, but Goodstein said it plans to use it in other ways in the future. "It will assist in developing our virology systems after the demand for COVID-19 testing subsides in the coming years," he said.

Goodstein noted that he and his team had considered a range of other instruments but found the EliTech system to be the best option for them because the unit is self-contained and because it had an EUA for COVID-19 testing.

"The self-extracting system poses less of a safety risk for our staff, which is a crucial consideration," Goodstein said, although he noted one drawback may be that it is a smaller system, so it can only do so many tests per day compared to higher-volume instrumentation.

Nevertheless, "EliTech has been a great strategic partner during this time," Goodstein said. "They managed the supplies well, which allowed us to take care of the kids in our region, [and] they also offered support to the state of Ohio and other small facilities that were interested in their services."

Gauer said that EliTech has faced some of the same supply chain issues that other diagnostics makers have encountered this year, noting that plastics consumables are a particular pain point industrywide.

"We need to be careful that we don't over-promise, and that is what is holding back the placement of instruments," he said, adding, "There is no point in placing instruments and then telling customers, 'We're sorry but we don't have consumables or extraction for you.'"

Striking the balance requires choosing where to place instruments so that customers can be assured a consistent supply of reagents in the future, Gauer said.

The industrywide ramp-up of manufacturing is also resulting in a sort of punctuated equilibrium, as building new lines and retraining staff slows things down before they can jump to the next level of capacity, Gauer said, noting that the firm feels confident it has also fully tackled an issue it had earlier in the pandemic with air freight.

EliTech has a research and production site in Bothell, Washington with the Nanogen and Epoch Biosciences business it acquired in for $25.7 million in 2009. Here, the firm does research and development and produces oligos, dyes, and quenchers for the assays, and it manufacturers all of the FDA-authorized and -cleared kits as ASRs for the US markets.

The firm is expanding both R&D and manufacturing now, and will continue working diligently on the FDA approvals, Gauer said.