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Euformatics Eyes Global Expansion in NGS Informatics

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CHICAGO – The worldwide growth of next-generation sequencing has Finnish NGS informatics company Euformatics thinking expansion into new parts of the globe.

Last month, in announcing that it had entered the Latin American market by granting Brazilian distribution rights to life sciences product distributor Síntese Biotecnologia, the firm also expressed a desire to move into Southeast Asia.

Euformatics CEO Tommi Kaasalainen specifically named Singapore, Thailand, and Malaysia as near-term targets, but did not rule out other countries, noting in an interview that the region's relative success at containing COVID-19 makes it a particularly attractive market to explore right now.

Espoo-based Euformatics had moved into Central Asia, the Middle East, and Africa by virtue of a distribution agreement with Dubai-based Alliance Global (AGBL) in late 2019.

The company also recently broadened its reach in Europe by virtue of a December agreement with Dynex Technologies to distribute its products in the Czech Republic. The Czech distributor is not affiliated with US-based medical equipment manufacturer Dynex Technologies.

Both Dynex and Belo Horizonte, Brazil-based Síntese will distribute OmnomicsNGS, Euformatics' CE-marked variant interpretation and reporting software, as well as OmnomicsQ, a quality control tool. Euformatics also offers OmnomicsV, a validation tool that Kaasalainen described as "kind of a subset" of OmnomicsQ that can be bundled with the quality control software.

While the Síntese deal only covers Brazil, the largest market in South America, Euformatics also has designs on other Latin American nations. Kaasalainen said that the firm has received funding from Business Finland, a government agency that promotes Finnish companies abroad, to target Latin America.

Kaasalainen considers Euformatics to be a global company, with customers "throughout Europe" as well as across North America, he said. The firm has named Dartmouth-Hitchcock Medical Center as a flagship customer in the US, and is in the process of installing its technology at two private clinical labs in the US and one large hospital in Canada, which Kaasalainen said the company would identify in the next few months.

Current clinical users include Biopticka Laborator — the largest cytology and biopsy lab in the Czech Republic — and Helsinki University Hospital in the company's home country.

Kaasalainen said that the technology is meant to be flexible, both in terms of handling data from  multiple clinical domains, and in user customization of screen layouts, filtering, and reporting.

"We trust that our customers know their field of expertise better than we do, so by putting the tools in their hands, we let them make the best decisions based on their situation," Kaasalainen said. He said that the company is still available to offer guidance to customers when necessary, particularly in markets where clinical genomics is nascent.

Among other recent developments for Euformatics is the hiring of Kaasalainen himself. He joined the company in September after serving as CEO of Nukute, a startup maker of wireless sensors for sleep apnea diagnostics.

From a strategic perspective, Kaasalainen is interested in finding partners in markets where NGS is being rapidly adopted in clinical settings.

"There is a lot of opportunity," he said, including in regions where the company has gained a foothold in the last couple of years. "Even if the markets themselves might be small, if we are present in all of those, then the aggregate impact is going to be significant for Euformatics."

Kaasalainen said that the COVID-19 pandemic has presented another opportunity for the company, particularly since the first full week of 2021, when the World Health Organization issued guidance to national health authorities on sequencing SARS-CoV-2 genomes.

With the rising concern about the spread of SARS-CoV-2 variants, sequencing capacity has increased as governments and public health organizations have installed new instruments in hopes of keeping track of variant prevalence in their jurisdictions, Kaasalainen noted. This variant tracking also is informing vaccine development and evolution as the world tries to control the pandemic that has killed at least 2.8 million people worldwide since March 2020.

Kaasalainen said that this WHO guidance has prompted Euformatics to examine how to update its interpretation and reporting products to fit with this uptick in demand for coronavirus variant identification. "I don't have anything to announce on that front now, but it's something that is in the works," he said.

The push to get ahead of SARS-CoV-2 variant spread has led to a larger installed base of Illumina instruments in particular. "In the long term, I think that's good for NGS in general," Kaasalainen said.

Since NGS itself has evolved in recent years, for a bioinformatics company like Euformatics, it is important to remain current in terms of classifying, annotating, and filtering different types of variants.

"We need to kind of chase science," Kaasalainen said. "[As] new types of genetic variants are discovered and their clinical impact is determined, then we will need to implement support for those variants into the product." That is exactly what the company is considering for SARS-CoV-2.

While datasets have grown in size and sequencing depth has increased, Kaasalainen said that Euformatics has always been able to support any FASTQ, BAM, or VCF file, regardless of the brand and type of sequencer the raw data comes from.

Long-term, Kaasalainen said that the company needs to "be more complete" in its product line, which currently lacks secondary analysis. "That gap we need to fill either through partnering or through our own solutions," he said.

Euformatics has had a mixed record with partnerships in the past.

A year-old pharmacogenomics agreement with Bio.logis to integrate their technologies has been slow getting off the ground. Kaasalainen said that he actually has not been involved in any discussions with Bio.logis since he joined Euformatics seven months ago, but is committed to the integration work because the need for pharmacogenomic services remains.

The firm has already integrated its software as a plug-in to Thermo Fisher Scientific's Ion Torrent system and as an app for Illumina's BaseSpace informatics platform.

Euformatics also has an ongoing partnership with two of the world's three major genomic quality assessment bodies, namely EMQN and the UK NEQAS for Molecular Genetics' Genomics Quality Assessment, or GenQA. The company has helped EMQN and GenQA develop an external quality assessment (EQA) program for NGS-based clinical testing that includes copy-number variation data.

This relationship is a point of pride for Kaasalainen. "This is how I would like to position the company from a thought leadership point of view, because this is kind of clear evidence of our leadership in this domain," he said.

However, the firm lacks any similar agreement with the other big player in EQA, namely the College of American Pathologists.