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EliTech Instrument Clearance Brings Unique Features to Mid-Size US Labs

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NEW YORK (GenomeWeb) – With a real-time PCR system and first assay recently cleared by the US Food and Drug Administration, EliTech Group is positioning its products to fill some unmet needs in the lab market.

The Bothell, Washington-based firm's Elite InGenius is a benchtop instrument that combines the rugged sample prep typical of higher-throughput qPCR systems with a more moderate throughput of 12 assays per run.

The Elite InGenius platform was granted 510(k) clearance last week along with an assay that detects and differentiates herpes simplex viruses 1 and 2. Overall, the platform brings a number of unique attributes to the market, according to Carl Hilliker, EliTech's senior vice-president of business development.

The system is fully automated, incorporating automated liquid handling with nucleic acid extraction and real-time PCR amplification and detection.

For extraction, it uses bead-based methods and has capabilities to do on-board sonication. For amplification, the InGenius has 12 separate Peltier-based thermal cyclers, so up to a dozen qPCR reactions with different cycling requirements could potentially be run simultaneously. The system also has multiplex detection capabilities, with six optical channels per unit, which enables it to run small panel assays, Hilliker said.

Importantly, unlike some other molecular platforms with moderate throughputs, the Elite InGenius is also an open system. It can be used to run IVD tests, such as the cleared HSV 1 and 2 test, but laboratorians can also use it to run lab-developed tests. "They can even run assays that they might buy from a competitor," Hilliker said, such as kitted assays from a manufacturer like Altona, for example.

It is also one of the few commercial molecular diagnostics systems that allows for storage of calibration curves, Hilliker noted.

The system is designed for labs in small to medium-sized hospitals with up to 300 beds, and has been targeted, so far, particularly to labs supporting transplant centers, although the firm is now expanding its reach.

Smaller locations that focus on esoteric testing may not require the powerhouse throughputs of, say, a Roche Cobas, an Abbott m2000, or a Panther system from Hologic, Hilliker said. He also observed that the competition among the 96 samples-to-results systems is high, and the potential customer base is somewhat more restricted. EliTech is trying to reach this customer base, where large systems wouldn't be a fit because they never do sufficient test volumes to justify the expense.

EliTech has presented data at a number of recent conferences, including the recent Association of Molecular Pathology meeting where investigators at Albany Medical Center Hospital, SUNY Albany, and Albany Medical College presented an evaluation of the HSV test using 181 clinical samples. They found high concordance with the lab's test of record (TOR), a conventional ligation-during-amplification PCR targeting the glycoprotein B gene with an enzyme-labeled oligo sorbent assay for amplicon detection.

"The Elite easy to use sample-to-result system offers enhanced workflow and significantly reduced time to results as compared with the TOR and other commercial methods," the poster authors concluded.

Another early adopter, Suzane Silbert, a clinical scientist at the Esoteric Testing Lab of Tampa General Hospital, presented data from her lab at the Clinical Virology Symposium this year. She showed that the EliTech cytomegalovirus test – which is not yet approved by the FDA – was comparable to the lab's standard DiaSorin Symplexa assay for that target. "The ability to load a sample on the instrument and walk away provides greater technologist efficiency compared to multistep PCR protocols," Silbert concluded.

Additionally, in her talk Silbert noted that the Tampa lab brought the EliTech system live in 2017 and subsequently participated in the clinical evaluation of the HSV 1 & 2 test. The assay was compared to the Quidel Lyra Direct HSV 1&2 and VZV test and to lab-developed PCR tests, and found to have 100 percent specificity and 95 percent sensitivity for both HSV targets.

In its FDA submission, the predicate device to which EliTech compared its assay and instrument was the Luminex Aries HSV 1&2 Assay, Hilliker said.

Like that system, the InGenius can run 12 sample-to-answer assays simultaneously, with a typical run time of 2.5 hours. This throughput exceeds many other molecular solutions that incorporate sample prep, such as the Cepheid GeneXpert, which has a system that can run four assays at once. It also exceeds the throughput of other point-of-care molecular systems that typically run one sample at a time, albeit with shorter turnaround times.

Other moderate throughput systems, such as the DiaSorin Liaison or Quidel Solana, tend to focus on assays that don't require nucleic acid extraction, Hilliker said. "Not every assay is amenable to that type of workflow," he added.

On the other hand, with notoriously challenging stool samples, DiaSorin and Quidel systems do seem to have found a way to avoid extraction. DiaSorin's Simplexa C. difficile Direct kit, for example, is a moderately complex test for the toxin B gene of the bacteria that can be used directly on unformed stool samples without extraction, and the DiaSorin Liaison system can run up to eight samples at a time in about one hour. The Quidel Solana – which uses isothermal amplification, not PCR – can also run 12 tests at a time, including a C. difficile assay for the toxin A gene that runs without extraction in about 30 minutes.

The most comparable system to the EliTech Elite InGenius might be the BD Max from Becton Dickinson. It can also run IVDs or LDTs, can execute small syndromic panels, and can mix and match up to 24 assays at a time.

"They are very similar," said Tampa General Hospital's Silbert in an email. Her lab actually uses both systems, for different tests.

As previously reported, the BD Max doesn't enable removal and storage of extracted nucleic acid on board, and it has five optical channels versus six on the EliTech platform. On the other hand, while the BD Max is also easy to use, it also already has an extensive menu with at least nine FDA cleared tests.

"The InGenius seems to be more flexible than the BD Max," Silbert said. For example, it has a universal extraction kit that can extract DNA and RNA regardless of the matrix. It can also run both qualitative and quantitative real-time PCR tests, and It is possible to program the InGenius to use the same specimen extraction for different PCR tests.

"Both instruments, though, are automated sample-in answer-out systems and have an open mode system, which make them an excellent choice for a clinical laboratory," Silbert said, adding "In our laboratory, we use both of them for different purposes [and] tests."

The Elite InGenius instrument's list price is $130,000 and the HSV assay's list price is $60, but Hilliker noted that the firm uses volume pricing and provides discounts.

EliTech has a very broad menu of products but has had limited sales resources in the past, Hilliker said, so the firm has traditionally focused its sales efforts on the transplant market, including transplant centers and children's hospitals.

Now, the firm is hiring new sales people in order to double its staff by the start of 2019, Hilliker said, and the new team will be looking at the markets it has already served but also expects to be expanding to infectious disease testing in general, at locations such as public health labs, for example.

The labs the firm is targeting may or may not already have molecular testing, he said. "This is a good entrance into learning molecular because now that it is FDA approved [a lab] can then take this product and basically duplicate that [IVD] workflow to achieve an ASR validation as well."

Still, EliTech is also targeting labs more likely to run LDTs, rather than those that exclusively run FDA-cleared assays, based on market surveys in which labs have indicated that they run non-regulated tests. "Those are our first call points," Hilliker said.

In the US, the firm currently has two other FDA cleared or authorized tests — an emergency use authorization Zika test, and an MRSA assay approved for use on the ABI 7500.

"The next plan for us in the transplant market is BK virus and [Epstein–Barr virus], and beyond that, we plan on bringing some of the CE-IVD products into the US," Hilliker said. The firm will sell these as research-use-only tests until it gains regulatory approval on them.

EliTech has at least 35 CE-IVD assays, including 17 for transplant monitoring. But in the US, the firm's goal now is to broaden its reach beyond the transplant market, Hilliker said.

It is now looking into bringing antimicrobial-resistance testing to regulators, for example, and the firm already has four assays in Europe that look at different resistance markers, as well as STIs, small respiratory panels, and assays for tick-borne pathogens.