CHICAGO – Last month, Qiagen purchased exclusive commercial licensing and distribution rights to the Catalogue of Somatic Mutations in Cancer (COSMIC) database from the Wellcome Sanger Institute. The deal, terms of which were not disclosed, will allow far wider distribution of the database than had previously been possible, the two parties said.
Cambridge, UK-based Wellcome Sanger has been offering the COSMIC licensing program since March 2015, but 95 percent of users are in academia or at healthcare systems, who get access for free under Sanger's academic terms and conditions, according to COSMIC Director Simon Forbes.
COSMIC's developers hope to "maximize our impact in the marketplace" and sustain "a large-scale, long-scale, long-term future," Forbes said. That includes adding "insightful" products like analytics tools and specialized curation on top of the database.
"Because we are existing at the Sanger Institute, we are focused on scientific excellence and data sustainability," Forbes said. "We decided a while ago that we were never going to want to grow a large-scale commercial team within a charitably funded institute."
He said that Sanger has an "enthusiasm" for technology transfer such as this, but that there always is a level of unease within the organization for building a large-scale salesforce, which led to discussions and, ultimately, the licensing deal with Qiagen.
"It was a perfect fit for what we are offering and it really fits well with our expertise in how to make this successful, how to bring this to all the users across the world," said Frank Schacherer, VP for products and solutions at Qiagen Digital Insights (QDI), the data and bioinformatics arm of Qiagen. QDI includes a collection of bioinformatics companies and technologies that go back more than three decades and incorporate more than just software.
Hilden, Germany-based Qiagen has a global reach, with sales teams in North America, Europe, Asia-Pacific, and Latin America. While there are no dedicated salespeople in Africa, the company does have distributors there, according to Schacherer.
"There's this kind of virtuous circle that that we're looking to sustain, whereby a small proportion of our users pay enough of a fee to sustain the team so that the rest of the world benefits from those developments," Forbes said.
Commercial users of COSMIC today include pharmaceutical and biotech companies, diagnostic labs, and informatics firms that support other licensees. QDI falls squarely into the third category, and already was a licensee.
"We knew firsthand the quality of the data before we had this discussion" of purchasing the exclusive commercial rights to COSMIC, Schacherer said.
COSMIC has more than 20,000 users, including researchers, bioinformaticians, and clinicians. The database of somatic mutations has been curated from about 27,000 scientific and clinical reports and 500 independent cancer genome studies, covering more than 1,500 types of cancer.
COSMIC continues to be a not-for-profit organization, and access to the data remains free for academic researchers. Fees for commercial licensing vary, based on the organization's size and intended use, and are waived for companies that collaborate in research with Sanger's COSMIC team.
Commercial organizations also can still access the information for free through the COSMIC website and run analysis through tools embedded in the site, though there is a fee to download data. The downloadable datasets contain more extensive annotations than the web version, according to Sanger.
Commercial licensing fees support growth of the COSMIC database as well as other Sanger Institute programs.
COSMIC launched exactly 17 years ago, on Feb. 4, 2004, as a public resource for genetic data. At the time, cancer genomics was somewhat nascent, but growing rapidly. "Precision medicine was fairly early-stage, but clearly had a lot of possibility," Forbes said.
"As the science around us grew and the literature around us grew, we needed to grow too," Forbes said. But the COSMIC organization was funded by charity and grants with specific time periods, which made it difficult to make the database sustainable for the long term.
"We wanted to make sure that we were fully available, fully reliable, and fully sustainable to really underpin quite a lot of the world's cancer genomics research," Forbes said.
The 2015 decision to add a commercial license "was really focused on growing us so that we could do more exciting things rather than just collect data," Forbes said. "We could begin to help people interpret it."
Since then, the COSMIC team has grown from nine employees funded entirely by charitable sources to 28 people.
"That commercial thing that we grew has allowed us to really make a much bigger impact in the market to provide more data, to provide more insights, and to really look to a more insightful future than we ever could have done," Forbes said.
However, the team Schacherer leads at Qiagen has far more commercial experience than Sanger, according to Forbes.
"The main challenge for these academic databases and resources is that once you have created it, how do you continue maintaining it and updating it and keeping it relevant and valuable for all the many thousands of users?" Schacherer said.
"Infrastructure" funding like grants tend to have set lengths of one to five years and are not meant to be sustainable.
The hybrid model of free access for academic users and sales to commercial customers has worked well for Qiagen with the for the Human Genome Mutation Database (HGMD), developed at Cardiff University. Qiagen gained the rights to HGMD when it acquired Biobase in 2014.
Schacherer called HGMD the "gold standard" when it comes to hereditary mutations. He sees COSMIC as filling a similar role for somatic cancer mutations.
Qiagen has built its knowledgebase through not only the Biobase purchase, but acquisitions of Ingenuity CLC, OmicSoft, and N-of-One. This collection now includes more than 40 databases, covering 33,000 and upwards of 20 million findings; some 5,000 new findings are added daily, according to the company.
Qiagen's support team now works with approximately 90,000 users.
"What is crucial is to have high-quality scientific content that you can leverage within the software to generate insight," Schacherer said. Manual curation, as Sanger offers for COSMIC, makes the content more trustworthy and reliable, he added.
Schacherer said it was difficult to estimate the market potential of COSMIC. He said that every pharma and biotech company that works in cancer is a sales target, but so are many hundreds of diagnostic labs, particularly in the US and Europe.
"Beyond that, there's a large and ever-changing community of informatic specialists building new tools to explore various aspects of data and combinations and supply to those sectors," Forbes added.
According to Schacherer, pharma and MDx both represent large potential growth areas for COSMIC, especially entities with multiple smaller labs, and noted that Qiagen has already had some discussions with pharma companies about licensing COSMIC in the last month.
"I'm really looking forward to hearing how those conversations progress, what that teaches us about the market, what that teaches us about was about customer needs, and then we can make sure that we're bringing that information back to COSMIC so that we can tweak the design," Forbes added.
Schacherer said it is "foundational" for Qiagen to be able to pass customer feedback along to Sanger so the scientific experts there can improve COSMIC.
Schacherer estimated that it will take six to nine months to make the partnership fully operational. Once the handover is complete, Sanger will be looking to recruit additional curators and informaticians, based on feedback Qiagen receives from the market, according to Forbes. "That will tell us with better resolution where we want to invest and where we should be developing, and I think that's where it starts getting exciting," he said.
Schacherer said that Qiagen is open to the idea of codeveloping with Sanger additional technologies to support COSMIC, though that is not part of the licensing agreement.
In the meantime, Sanger already is working on new tools around COSMIC.
Last summer, the organization introduced a cancer mutation census, providing metrics on protein structure properties to help researchers interpret the 35 million coding mutations already in COSMIC. This complements the long-established COSMIC gene census.
Forbes said that the mutation census will be particularly useful in helping diagnosticians interpret variants of unknown significance.
"This is very strongly aimed at giving people robust data that isn't simply a black-box algorithm," Forbes said. "It's a series of actual measurements to interpret [variants of unknown significance] and begin to say which ones matter beyond the ones that we already know."
Soon, COSMIC will release a more clinically oriented product that Forbes said will assess the treatability of mutations based on available drugs.
Forbes said that he is excited about receiving feedback from the Qiagen sales team because it will help Sanger fine-tune COSMIC and related bioinformatics tools to the needs of the user base. He called the informatics aspect important in "making sure we're feeding the diagnostics industry with the most useful insights across these mutation types."
The same goes for pharmaceutical users regarding variants of unknown significance. "If you don't have any drugs in precision medicine, it doesn't matter if you can diagnose anything if you can't treat it, so we're making sure we're developing insights that tell diagnosticians which of the VUS matter and which ones don't, which mutations matter, and which ones don't," Forbes said.
He said that it is equally important for pharma researchers to know how to characterize and understand drug targets across stratified populations.
Forbes said that both parties are looking at this as a long-term relationship. "You don't go into a partnership like this for one, two, or three years," he said.
Schacherer said that Qiagen has already reached out to existing commercial COSMIC customers to explain the transition, and said that the response was "overwhelmingly positive."
He added that more Qiagen news about COSMIC is forthcoming in the very near future. Qiagen is due to report its 2020 fourth quarter and full-year financial results next week.