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Congenica Eyes US, Chinese Markets, Plans Product Upgrades Following $10M Financing Round

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NEW YORK (GenomeWeb) – Congenica, a Cambridge, UK-based genomic analysis company, announced this week that it has closed a £8 million ($10 million) round of Series B financing that it will use to build its commercial operations and further develop its product.

CEO Tom Weaver and COO Nick Lench said in interviews that the company will use the proceeds to establish its presence in the US and China, where it will court not only clinical genetics laboratories, but specialists, academics, and biotechnology and pharmaceutical firms as potential customers for its flagship Sapientia genome analysis platform.

Moreover, the two-year-old Wellcome Trust Sanger Institute spinout is looking to fold its experience working with initial partners like Genomics England into an improved version of Sapientia, which enables customers to generate diagnostic reports, primarily for rare diseases, based on patient symptoms and next-generation sequencing generated genomics data.

In line with those plans, Congenica is expected to hire around 20 employees, from bioinformaticians to software developers to field support, raising its headcount to about 65 people.

Lench said that the company's partnerships to date, notably with Genomics England, where it generated diagnostic reports for the 100,000 Genomes Project, had put Congenica in a position where it could look to expand beyond its home market in the UK.

"If the UK's clinical geneticists and scientists are willing to use and endorse our product then it's a great marketing tool for us to take out to the rest of the world," said Lench. "That's been our strategy. Now we are at the point, particularly with this new funding, that we can start to really take our product out to the US and China."

Congenica made its initial foray into the US last month when it tapped Shikha O'Brien to be its chief business officer. O'Brien, based in San Diego, will oversee the company's efforts to reach new customers in the US market. Weaver, who has led Congenica since its inception, said that Congenica is in the process of setting up a US commercial office on the West Coast to manage a direct sales force, business development, and direct technical support for growing its base there.

It will also put Congenica in the same territory as competitors like Oakland, California-based Omicia, which sells Opal, a variant interpretation and reporting platform for handling NGS data.

Weaver said that the company's "determination to optimize the clinical interpretation workflow" will set the firm apart from competitors, noting that its partnerships have allowed it to create a product that is "designed and optimized for clinicians and researchers."

Indeed, Congenica markets Sapientia as a scalable platform that can serve individual users or national testing programs, moving cases from sequencing to annotation to interpretation and the generation of a final report. Customers can upload any kind of genomic data, gene panels to whole genomes, describe the phenotypes using a built-in interface, and add annotations in any format. All genomic file formats are also accepted.

Lench called the US market a "massive opportunity" for Sapientia and said that by having a US-based team, the firm hopes to be more competitive. "Without a physical presence in the US, building brand awareness has been difficult," he said.

In the US, Congenica will target diagnostics labs that provide NGS-based tests, including hospitals with a focus on pediatric or clinical genetic research. "We will also work with integrated service providers and large commercial CLIA labs," said Weaver. The company will also look to market Sapientia to biotech and pharma firms in the US and Canada.

While the US seems like a natural next step for a UK company, China is equally enticing. Congenica hopes to develop business-to-business relationships, in addition to working through direct channels, to make Sapientia available to potential Chinese users, Lench said.

"China is a new frontier," said Lench. "What is impressive about the Chinese is that when they decide to go for something, they go for it big time.When you think of BGI and the amount of testing they are doing, it's mind boggling. From a commercial point of view, if you are able to sell into a massive market, that's obviously attractive."

Congenica is also keen to capture some of the genetic information from this "sheer volume" of potential Chinese subjects, which would allow the company to build up its expertise and knowledge base quickly, Lench said. He said that Congenica aims to work with partners in clinical and medical genetics in China to get its foot in the door, while developing relationships with "key hospitals and laboratories" that it hopes will adopt Sapientia in order to better deliver genetic testing to their patients.

Reaching out to customers in these new regions also means that Congenica plans to diversify its offering, and with the new investment, new product development is in the pipeline. According to Weaver, company R&D will be focused on further automation of analysis, additional disease-causing variant prioritization methods, and enhanced scalability of the infrastructure. "We also intend to further expand our clinical decision support tools for screening genetic conditions beyond undiagnosed rare diseases," he said.

Congenica aims to parlay some of the experience it has gained working with Genomics England and other projects, such as the UK's Prenatal Assessment of Genomes and Exomes (PAGE) Study, into future versions of Sapientia.

"These landmark partnerships have allowed us to develop a platform in real-world settings," said Weaver. "For example, it's now possible for multi-disciplinary teams to review a patient report securely and remotely and Sapientia allows users to keep a record of decisions made, showing an audit trail," he noted. "Both programs have been extremely helpful."

Lench said that Congenica would also like to develop new versions of Sapientia suitable for a variety of user groups.

"Currently, if you provide a genetic diagnosis for a patient, it's really the medical genetics community that provides that diagnosis," said Lench. "We see that as more patients get access to genetic testing that's not sustainable."

Congenica sees its role as providing a platform to "democratize genetics," Lench said, by making it available to specialists, such as radiologists or neurologists, who could directly provide a diagnosis to their patient. This group might in the future license a "slimmed down version of Sapientia," one that lacks "all the bells and whistles, something like Sapientia Lite," said Lench. "That's clearly an area that will evolve."

Congenica could similarly create a version of Sapientia for biotech and pharma customers, one that might be "more of a research and discovery-focused product" that will enable them to discover new genes, stratify patients, and study shared haplotypes and markers. "There are different flavors of the product that we can develop," he said.

In December, Congenica announced a deal to provide the data analysis and interpretation component of Manchester, UK-based Elucigene Diagnostics' next-generation sequencing-based kit for cystic fibrosis testing.

Lench said that the partnership with Elucigene provides a blueprint for how Congenica could tailor Sapientia to suit the needs of a variety of customers, such as those that serve the reproductive health market. This would be another potential area of product development going forward, he noted. Weaver agreed and said that the firm would seek out similar deals in the US and China.

"Things like newborn screening panels would be a sensible place to start," said Lench. "For us it will be interesting to see the uptake with Elucigene and will be interesting to see how well we will do working with a partner like that that serves markets across the globe. It's a way of exposing us to new customers."

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