NEW YORK – With recent hires at its US subsidiary, Seegene has signaled an enhanced focus on US commercial expansion, intending to leverage its PCR multiplexing capabilities — including a new chemistry that enables reporting Ct values from three targets in a single channel — and its collaboration with Bio-Rad Laboratories to develop a suite of multiplex PCR assays for the US market.
Korea-based Seegene initially established its US affiliate, Seegene Technologies, in 2015, but to date the subsidiary has emphasized sales and distribution of products developed and manufactured in Korea.
Last month, however, the firm brought in diagnostics industry veteran Richard Creager, who previously was an executive at Beckman Coulter, as CEO and Glen Hansen, a former clinical lab director for Hennepin County Medical Center in Minneapolis, as head of scientific and medical affairs.
While Seegene has had a significant presence in many countries, the US is one of the largest global markets for diagnostics, and the firm realized that it needs to be present here in a bigger way, Creager said in a recent interview.
"We're embarking on a major investment strategy in the US to become a significant player in the molecular diagnostics space," Creager said.
The firm will establish a full-scale diagnostics company in the US, including research and development of products optimized for the US market, he said. The products will be manufactured in the US as well, which the firm expects will lower costs and expedite delivery to US customers.
Seegene Technologies expects to establish the US facilities for this endeavor over the next few months, likely located on the West Coast, Creager said.
The company also plans to make "significant investments" in the coming months to hire new talent for its US-based research and product development, manufacturing, quality assurance, clinical studies, and regulatory affairs, Creager said.
Creager's own history with Seegene began when he was senior VP of molecular diagnostics at Beckman Coulter, where he helped coordinate a collaboration to develop multiplex assays for the DxN Veris system. He most recently worked as an industry consultant, as well as a COVID diagnostics consultant to the National Institutes of Health RADx program, and he began consulting with Seegene one year ago to help establish the firm's US strategy.
Bio-Rad, multiplexing, and a focus on customers
Over the past year, Seegene has debuted a modular sample-to-answer system called the STARlet-AIOS and received the CE mark on a 30-minute isothermal SARS-CoV-2 assay on the system for launched research-use SARS-CoV-2 genotyping assays. The firm also garnered regulatory approval in Canada for a multiplex test for respiratory pathogens — including SARS-CoV-2, influenza A and B, and respiratory syncytial virus — as well as approval in Australia for a test to detect a total of 19 respiratory viruses.
A major element of Seegene's US expansion going forward involves its ongoing collaboration with Bio-Rad. "We're providing the assays, and they are providing the instruments," Creager explained.
As described by Bio-Rad at a recent investor day, the collaboration is also a lynchpin of that firm's future diagnostics strategies with Bio-Rad executives calling it a $2 billion opportunity.
Seegene expects to enter clinical trials for the first product from the Bio-Rad collaboration in the fall.
One of the core PCR technologies developed by Seegene incorporates single-tube multiplexing of up to approximately 20 targets. This week, the firm also debuted a new technology, called 3 Ct, that can report three Ct values per channel. The company plans to apply 3 Ct technology to its entire product menu, according to a statement.
Creager said the Seegene multiplexing technology has advantages over other syndromic testing methodologies, such as those that use arrays, because it is a single reaction. In addition, Seegene has a catalog of component assays that are already in use all over the world and could be incorporated into a multiplex test, he said.
Other realms of diagnostics have experienced a trend toward consolidation of testing, and while the molecular space remains highly fragmented, with most customers utilizing many different systems, molecular will likely also consolidate once companies have the appropriate menu, Creager said. In this scenario, "our technologies allowing high multiplexing in a single reaction offer significant advantages over the competition," he added.
In the multiplex PCR space, there are not many assays commercially available that can test for approximately 20 targets simultaneously. A major competitor might be the BioMérieux/BioFire FilmArray, which also has a 12-year head start in the US market. Highly-multiplexed PCR technologies are also being commercialized by firms like Luminex/DiaSorin, Lexagene, Applied BioCode, GenMark, Qiagen, QuantumDx, and Genetic Signatures, while makers of multiplex PCR diagnostics in the five- to 10-target range include companies such as Becton Dickinson, CoDiagnostics, Quidel, and many others.
Seegene is now taking a test that genotypes SARS-CoV-2 through the US Food and Drug Administration for Emergency Use Authorization. Next will be a combined test for COVID, influenza A and B, and respiratory syncytial virus. This particular test can also detect two to three variants per virus, with multiple targets within each gene, to improve specificity and mitigate the effects of genetic drift.
Beyond the respiratory space, Seegene is considering a menu of multiplex assays for sexually transmitted infections, hospital-acquired infections, viral load, gastrointestinal illness, and pneumonia, as well as potentially sepsis and antibiotic resistance testing.
These will all run on Bio-Rad instruments, Creager said. "We are their assay developer for molecular diagnostics in infectious disease … and we are trying to add menu as quickly as possible," he said.
Bio-Rad will be responsible for the distribution of joint products, while marketing will remain a partnership. The firms happen to be located a few miles from each other in Northern California, Creager said, and have in-person meetings two to three times each week.
While the Seegene/Bio-Rad partnership focuses on infectious disease, Seegene is also looking into developing tests in other disease areas in the future.
"We are starting to put more chess pieces on our board," Creager said. "We have a vision to become a significant player in the US market. Seegene is relatively unknown [here], so we really need to increase our brand awareness."
One strategy for increasing awareness among laboratorians is to add key opinion leaders onto advisory boards or bring them on staff.
In his new role at Seegene, Glen Hansen can add a customer perspective, which can help the firm's customer-driven US strategies, Creager said. Hansen will also be leading clinical and scientific studies for Seegene.
In an email, Hansen noted that partnerships between industry, commercial sectors, and healthcare have enabled many positive outcomes during the pandemic. In his view, the new role at Seegene now offers him an opportunity to support clinical testing labs throughout the country. Hansen has used Seegene tests in his 20 years of experience evaluating diagnostics technologies and has personally noted how the products benefit patients, physicians, and communities, he said.
The pandemic has also impacted the diagnostics space in profound ways, particularly in the attention it has brought to the fact that patient outcomes are dependent on diagnosis, Hansen said. "It's a wonderful time to be involved in diagnostics," he said.
Creager noted that he and Hansen know a lot of the key labs around the country. "I think we will be successful in getting people excited about what we have to offer," he said.