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Seegene to Enter Sample-to-Answer MDx Space With Modular 'Walkaway' System

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NEW YORK – Molecular diagnostics developer Seegene plans to enter the instrument space with a novel, modular sample-to-answer system called the STARlet-AIOS.

The system, which the firm debuted at the American Association for Clinical Chemistry annual meeting last month, incorporates standalone instruments and robotics. Seegene plans to launch it early next year and is also developing a suite of highly multiplexed syndromic PCR assays to target the diagnostic needs of small to mid-size hospital labs.

The All-In-One System, or AIOS, merges a standalone sample-prep unit from Hamilton called the STARlet with two CFX96 thermal cyclers from Bio-Rad Laboratories.

The Seegene team has bridged these with its own robotics, software, and proprietary diagnostic assay technologies.

Bruno Larida, VP of marketing at Seegene's US subsidiary, Seegene Technologies, said in an interview that customers who already have components of the modular system can use them in the STARlet-AIOS and simply purchase the additional robotics and software.

"We'll integrate that and create an AIOS for them," he said.

After the Hamilton STARlet performs extraction and PCR preparation, an elevator in the system takes the sample plates to an automated plate sealer, then robots transfer the plates to the CFX96 instruments.

"The combination of all of these standalone instruments provides complete automation," Larida said, adding that the system is fully walk-away, from sample in to results out.

The system can also perform thermal cycling and sample prep simultaneously. So, while each batch takes about four hours to process, a second batch can be started on its sample prep steps about two hours after the first batch is begun.

The software also allows users to omit adding reagents to specified wells, so they don't necessarily need to wait for a full batch of 94 samples to be assembled.

Globally, Seegene was one of the first firms to develop a SARS-CoV-2 test in January 2020, with an assay available in the Korean market the first week of February.

Larida noted that the team's methods, which combine artificial intelligence and big data analytics, allow it to develop new assays in silico in as little as four days. The team has also been creating methods for oligo development that has continued to evolve, Larida said.

The firm uses three chemistries — dual-priming oligonucleotides (DPOs), tagging oligonucleotide capture and extension (TOCE), and multiple detection temperatures (MuDT) technology — that also lend themselves to high-level single-tube multiplexing.

Specifically, DPO adds specificity by having two docking events on each side, while TOCE and MuDT provide real-time signal generation and enable multiple melting temperature analyses in each optical channel. This allows the system to simultaneously detect and quantify up to 10 targets per channel from a single reaction.

The Seegene team identified a particular need in the market for total automation during the pandemic. "We thought developing a system that would address the needs of small- to mid-size hospitals would lighten the load on large hospitals, and also address the problem of medical technologist shortages," Larida said.

User insights

Valerie Ng, director of the lab at Alameda Health System in California, has been using the Hamilton STARlet and Bio-Rad CFX96 along with the Seegene assay components — but not the STARlet-AIOS per se — since December 2020 for SARS-CoV-2 testing. Prior to that time, they were reliant on Hologic Aptima assays on a Panther system, Ng said in an email.

By way of comparison, Ng said that both workflows are "pretty 'hands off' and 'walk away,'" but that a significant advantage of the Seegene setup is that it does not require a bleach decontamination step, as does the Panther. The US Food and Drug Administration issued a warning to labs last year noting that the guanidine isothiocyanate in some types of transport media can potentially interact with bleach to produce cyanide gas.

In the past 10 months, Ng's lab has tested more than 30,000 samples for SARS-CoV-2 using the Seegene workflow.

Importantly, Ng said her clinical lab team had no prior experience with molecular testing, but the Seegene workflow proved to be hands-free and problem-free for them. "Seegene truly met the need of a small to moderate-sized clinical laboratory," she added.

The lab has had no issues with specimen carryover or contamination, and "technical performance has been outstanding," Ng said, with only rare "invalid" results. Ng also said she has appreciated Seegene's customer service and competitive pricing.

"Seegene was able to source us pipette tips, test reagents, 96 well plates, and other consumables at a time when the supply chain for SARS-CoV-2 testing was severely constrained," she also said. "All around, this was a most favorable and successful acquisition and implementation for our health system."

Given how well the workflow performed during the pandemic, even with all the "extenuating staffing and supply chain circumstances," Ng expects the workflow will likely perform well under non-crisis conditions in the future.

Although the lab has only been using the setup for COVID-19 testing, Ng said Seegene's other menu — which currently includes a total of 51 assays detecting 188 targets — is intriguing.

However, her team would "dearly love for Seegene to obtain FDA clearance or EUA for them first," she said, because, without FDA approval, these would have to be implemented as laboratory-developed tests, "a significant burden" for small- to mid-sized clinical labs.

"We remain hopeful Seegene will obtain FDA clearance of these many other tests so US clinical laboratories can simply implement tests of interest without undertaking LDT validation studies," she said.

Glen Hansen, a microbiologist at Hennepin Healthcare in Minnesota, is also not currently using the STARlet-AIOS system in his lab, but has seen it demo'd and is using some of the firm's assays as LDTs.

Hansen said that the pandemic has shown the value of automation for clinical labs, as well as the need for flexibility in run sizes and reduced turnaround times.

The STARlet-AIOS "provides a much-needed advance in laboratory automation for COVID-19 testing and additional syndromic testing," Hansen said.

As the pandemic drags on, technical staff remain the most challenged resource, he also said, so "integrating extraction, liquid handling, and PCR in a single fully automated platform ... offers the provision of quicker time-to-reporting and the flexibility of custom run sizes while providing efficiency gains in testing for a stressed workforce."

Collateral COVID benefits

The COVID-19 pandemic had a collateral benefit of allowing Seegene to raise its public profile, and the firm's business has grown about 10-fold in both the US and in Korea, Larida said.

The pandemic also helped the firm showcase an ability to develop new tests "in an extremely fast manner," Larida said, as well as an ability to supply its customers all over the world without interruption.

"We never put any of our customers on allocation," Larida said.

This is because, although the technology is innovative, its simple design means the manufacturing is not as complex as, say, cartridge-based systems that experienced shortages of plastics, electronics, or other raw materials.

The firm also pre-stocked supplies early in the pandemic, Larida said, and thus was able to supply things like tips and plates to its customers.

Going forward, the firm plans to focus its gains on a menu of syndromic tests, including assays for respiratory, gastrointestinal, and sexually transmitted infections.

Developing syndromic tests had been a goal at Seegene for many years, Larida said, in part because its proprietary chemistries support highly multiplexed testing. Indeed, the firm had already been developing panels for about five years, he said, adding that the pandemic has shone a spotlight on diagnostics that has now allowed Seegene to push this technology closer to commercialization.

The ways in which syndromic panels will be reimbursed is still somewhat of an open question in the market, but Seegene expects to offer its panels with a software tweak enabling masking of results for targets, if needed. Seegene's development and manufacturing costs are low enough to make this approach competitive, Larida said, adding that outside the US, the pathway to reimbursement may be more straightforward.

The individual components of the AIOS system — namely, the Hamilton STARlet and Bio-Rad CFX96 — are already validated for all of Seegene's globally available catalog of assays.

In the US, the company's only regulatory approval is its Emergency Use Authorization for the SARS-CoV-2 test, which is authorized for use on multiple different systems, including the STARlet and the CFX96. Seegene is now in the process of determining the exact requirements to authorize the assay for use on the AIOS system specifically, Larida said.

Globally, Seegene also offers a complete lab solution called the Seegene Mobile Station, which the firm debuted to help with SARS-CoV-2 molecular testing in resource-poor regions. Essentially, "we integrated a molecular diagnostics lab into a shipping container," Larida said, with different compartments to separate extraction from amplification. The station can be provided as just the container or as a complete lab filled with Seegene instrumentation.

In North America, the firm saw 68 percent revenue growth in the most recent quarter, which Larida attributed to COVID-19 sales, including variant detection assays. Also, when test volumes declined before the Delta variant emerged, some labs with excess capacities began validating other assays, such as the firms sexually transmitted infection and respiratory viral assays, he said.

The Seegene-Hamilton collaboration began in 2017. Larida, who was formerly a global marketing director at Bio-Rad, noted that Seegene also has an assay development partnership with Bio-Rad which stipulates that Bio-Rad will distribute the firm's infectious disease tests in the US once they are cleared by the FDA. In the meantime, all the RUO assays are distributed by Seegene in the US, he said.

The firm has filed pre-submissions for a combination panel to detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus. It plans to start a clinical trial as soon as possible, but may need to work around the fact that there is not much flu circulating currently.

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