CHICAGO – Last month, WuXi NextCode changed its name to Genuity Science and announced plans to restructure as a single entity while it divests its operations in China in the wake of a controversy that reached the US Senate.
The move ushered in the final stage of a three-year transformation of the firm, which started when executive leadership and eventually company headquarters moved from Shanghai to Boston. The company expects to shed the China operations by the end of the year, CEO Rob Brainin said.
The newly renamed Genuity Science — which is not related to business analytics and IT management firm Genuity — offers contract genomics and artificial intelligence-driven data sourcing and data analytics services to the biopharmaceutical industry to support drug discovery and development. Brainin said to expect several announcements in the next few weeks and months as the reorganized company gets a handle on its new operations and business model.
In addition to its Boston base, Genuity Science has offices in Reykjavik, Iceland, and Dublin, as well as CAP-accredited, CLIA-certified sequencing laboratories in Woburn, Massachusetts, and Dublin.
"We've continued to build out the capabilities of both of those labs to be able to serve our biopharma customer base," Brainin said.
The company's new name, which plays on the word "ingenuity," is more in line with its mission and strategic direction.
"We think of ourselves as a genomic data and insights company and what we do is bring together a diverse set of capabilities to be able to integrate genomics into biopharma," Brainin said.
"We've got data sourcing and the creation of large-scale genomic and phenotypic datasets, as well as next-generation sequencing capabilities, as well as some advanced analytical capabilities, including AI," Brainin said. "We bring those together in a way to help biopharma across the discovery and development continuum."
He said that the newly rebranded Genuity Science has similar bioinformatics and sequencing offerings to Amgen, which acquired Decode Genetics in 2012. What is now Genuity Science actually was founded as NextCode Health in 2013 as a spinoff of Decode, and Iceland-based Amgen subsidiary before WuXi PharmaTec, a provider of laboratory and manufacturing services for biopharma and medical device customers, purchased NextCode in 2015.
Brainin said that Genuity Science partners with biopharma companies to help them discover and validate drug targets, identify biomarkers, and stratify responders and nonresponders in clinical trials.
Genuity Science calls itself a personalized medicine company, but exclusively works in the biopharma industry. "Longer term, we do see an opportunity to integrate genomics into clinical care," Brainin said.
The rebranded company is continuing to seek a buyer for WuXi NextCode's Shanghai operations. The divestment process started a year ago amid security concerns regarding changes to China's Human Genetic Resource Regulation. Two influential US senators raised questions in June 2019 about the security of patient data, given that WuXi NextCode had a relationship with Chinese state-owned telecommunications firm Huawei.
The Dublin operations were previously known as Genomics Medicine Ireland. Irish media had also raised questions about WuXi NextCode's data security practices, though executives said last year that data collected in Ireland was compliant with the EU's General Data Protection Regulation.
Company officials said that this is still the case.
Genuity has already completed the "operational separation" of the Shanghai office and the integration of the US, Iceland, and Ireland offices, according to Brainen. "The complete financial and legal separations are happening in transition over the course of the year," he said.
There also have been some governance changes, including a restructuring of the board. The board now includes representation from investors in the US, UK, and Ireland, as well as external subject-matter experts in drug discovery, data protection, and the integration of genomics into drug discovery.
"We're bringing in some of the capabilities that will enable us to succeed as a company," Brainin said.
Due to GDPR, the company is maintaining the Genuity Science Ireland board on the Emerald Isle to manage European data.
Iceland is outside the EU, but it is a member of the European Free Trade Association, and thus part of the European Economic Area. "For all intents and purposes, from an operational perspective, we comply with EU regulations," COO Anne Jones said.
Most of the high-throughput work, including whole-genome sequencing and whole-exome sequencing, to support population genomics, is performed at the Dublin lab because population genomics data collected for EU citizens needs to be stored in Europe for GDPR compliance. Tumor and single-cell sequencing tends to happen in the Boston-area lab, particularly with the Illumina TruSight Oncology 500`x pan-cancer assay.
Jones said that there is backup at each lab so each can pick up extra volume from the other if necessary.
"We really think about our sequencing business as part of our data and insights business, because in order to deliver end-to-end analytical capability to the industry, we want to be able to generate the data as well," Brainin said.
"I would consider Illumina's instrumentation to be a primary workhorse to process the data, which then sits on [our analytics] platform," Jones said.
Genuity primarily uses Illumina NovaSeq instruments for its next-generation sequencing. The company has a deep relationship with Illumina, and actually hired Brainin away from Illumina in 2017 to be COO. Brainin ascended to the CEO role in 2018.
Much of the software has been developed in the Iceland office, but the company does have analytics researchers at all of its locations. Jones said that analytics is a central piece of its offerings to the biopharma industry.
The company has a data center in Dublin. The Irish operation also manages all European data that is stored in the cloud, again, for GDPR compliance. Nearly all new sequencing data goes directly to a cloud platform, Jones said.
The company is three years into a 15-year partnership with AbbVie to use population genomics to discover and develop novel therapeutics and companion diagnostics for a range of chronic diseases in oncology, neurology, and immunology.
Under that deal, the former Genomics Medicine Ireland is collaborating with clinicians and researchers to sequence the genomes of 45,000 Irish volunteers, gather their medical information, and collect the data into a research database. The Genuity Science integrated genomics platform is organizing and mining the database to help AbbVie investigate new molecular approaches for therapeutic drug discovery and development, as well as to develop companion diagnostics.
Abbvie and Genuity Science are conducting population genetics studies with what Jones called "deeply phenotyped" data for seven specific diseases. The two companies are farthest along in multiple sclerosis and inflammatory bowel disease, specifically Crohn's disease and ulcerative colitis, she said.
"Not only are we looking at the genomics, but a lot of the clinical and the lifestyle data for the population which we're working," Jones explained.
To China and back
The firm acquired Genomics Medicine Ireland in 2018, the same year it closed a $200 million Series C funding round. WuXi NextCode also had a $240 million Series B round and $30 million in a Series A.
Formerly headquartered in Shanghai, the company took the WuXi NextCode name in 2015 after WuXi PharmaTec acquired NextCode Health and later stood it up as a separate operating unit.
WuXi NextCode was one of three companies that provided clinical interpretation services for the UK's 100,000 Genomes Project. It eventually won the contract to interpret all genomics data from patients with cancer and rare disease in the program.
The firm also has had partnerships with Sidra Medical and Research Center in Qatar, and Rhythm Pharmaceuticals, the latter for uncovering genetic markers for rare metabolic syndromes.
In 2018, WuXi NextCode teamed with Google to integrate its genomic data analysis platforms with the Google Cloud platform and genomics research tools.
In 2018, the company introduced LifeCode.ai, a health databank that uses blockchain technology to manage health data securely. The databank encrypts and stores user data multiple times, and the information can only be accessed with user-specific authorization.
When COVID-19 emerged from Wuhan, China, and reached Europe in early 2020, Ireland's Health Service Executive tapped what is now Genuity Science for testing support because the company has about the largest genomics operation in the small country.
Since the novel SARS-CoV-2 virus reached Ireland, Genuity Science has provided reagents for more than 200,000 tests, Jones said. The company performed the majority of COVID-19 tests in the country in April and May on behalf of Ireland's Health Service Executive, she said.
The firm also is providing sequencing services on numerous SARS-CoV-2 research projects across Europe, thanks largely to partnerships with Illumina and the UK-based European Genome-phenome Archive.
Collection of prospective samples from non-COVID-19 patients has slowed during the pandemic as orders for genetic tests have waned while many medical offices were closed and while the Republic of Ireland severely restricted the movement of its citizens during a nationwide lockdown this spring, according to Jones. However, the Dublin lab has continued processing many samples, including those for SARS-CoV-2 testing.
"For the most part, we're only as impacted as our potential partners may or may not be," Jones said. But the company was performing services that had been deemed critical even during the lockdown.
Brainin noted that genomics currently is popular in oncology and rare diseases, but is still underutilized in pharmacogenomics. "We actually see a broader opportunity to have genomics and other omics be really more tightly integrated into a patient's healthcare journey from diagnosis to therapeutic selection," he said.
However, he noted that in the short term the reality is that "there isn't yet [a] deep-enough understanding for there to be broad-based clinical adoption outside of some of the core areas I mentioned."
He does believe, though, that there will be more opportunity to bring genomics into "day-to-day healthcare" as new therapeutics can be correlated to patient genomic profiles.
Brainin believes that scenario is still several years off. "We have some future plans around that, but in the short term, we are really focused on serving and collaborating with the biopharmaceutical industry," he said.