QIAGEN acquires N-of-One, expanding its clinical bioinformatics capabilities in molecular oncology decision support

The addition of N-of-One will enable QIAGEN to significantly expand its decision-support solutions while offering a broader range of software, content and service-based solutions. It will also enable QIAGEN to provide customers with greater access to valuable genomic data assets and service offerings.

N-of-One’s technology-enabled, yet human-driven, services and the proprietary MarkerMine™ database are planned to be integrated into QIAGEN Clinical Insight (QCI), enhancing this industry-leading clinical offering with medical interpretation and real-world evidence insights and offering robust decision support in oncology. 

The proprietary database, services and processes of N-of-One produce case-specific reports based on data generated with molecular tests, including next-generation sequencing (NGS) technologies, and deliver clinical evidence for biomarkers and a list of therapeutic options for consideration. N-of-One also provides patient-specific clinical trial matching services and a somatic cancer database with more than 125,000 anonymized patient samples. This data will be added to the patient samples currently available in QCI, further increasing QIAGEN’s position in offering by far the largest genomics knowledge base.

“N-of-One has made tremendous strides in molecular oncology decision support, and their combination with QIAGEN’s own pre-curated knowledge base of evidence will provide powerful new tools to expand our abilities to deliver patient-specific insights,” said Jonathan Sheldon, Senior Vice President of QIAGEN’s Bioinformatics Business Area. “We look forward to combining N-of-One’s Precision Insights and Rapid Insights reporting tools, as well as their MarkerMine database, into our QCI portfolio, which is a leading integrated solution for NGS analysis and interpretation. This will further strengthen QIAGEN’s leadership in clinical decision support and provide customers with solutions powered by real-world evidence Insights.”

“We are excited about expanding N-of-One’s impact. With QIAGEN’s resources and reach, our combined technology will provide more patients with greater potential therapeutic strategies,” said Christine M. Cournoyer, CEO of N-of-One, Inc.

QIAGEN believes the addition of N-of-One advances its bioinformatics strategy while also providing access to new opportunities emerging to support healthcare providers and payers with access to real-world evidence (RWE) insights: 

• Strong brand recognition: Oncology is the most advanced area for clinical decision support use, and N-of-One is one of the best-known brands in oncology decision support. It is well-established with labs pharma companies and payers. The acquisition will highly complement QIAGEN’s leadership in bioinformatics and will benefit the already very rapid growth of QCI.
   
• Addition of expert-delivered, professional patient data review to QCI: The combination of N-of-One and QCI platforms creates a strong foundation for QIAGEN to add a new level of engagement with the professional patient data review services offered by N-of-One and provided by its employees, which together will improve the overall QCI offering for customers.
   
• Addition of clinical trial data and analyses to QCI: N-of-One has developed capabilities and tools to add insights from clinical trials data to insights derived from literature. This adds an important data layer for healthcare providers to achieve improved test interpretation and decision support, and also for payers to develop evidence frameworks for reimbursement and other protocols for genomic data interpretation.
   
• Real world evidence solutions as attractive growth opportunity: The addition of N-of-One’s MarkerMine database and commercial data rights creates an attractive and expandable link into real world evidence insights. Genomic Insights/analytics services can be commercialized to pharmaceutical industry partners – in particular to more than 25 companies with which QIAGEN has deep companion diagnostic co-development relationships – to support patient cohort analytics, patient stratification, trial protocol design, assay design and interpretation, trial accrual and market forecasting, patient-to-trial matching and other features. 

QCI is the leading integrated solution for NGS analysis and interpretation, and the addition of N-of-One will make it even more valuable for labs in analyzing and interpreting NGS data in a broad range of applications. QIAGEN recently announced major improvements to this offering that is anchored by applications for oncology and hereditary diseases. Powered by the QIAGEN Knowledge Base, QCI can annotate, interpret and report NGS variants in the context of over 10 million relevant biomedical findings while building the user’s internal experiential knowledge base. The best-in-class workflow minimizes the complexity, time and cost of determining clinical significance and actionability of NGS variants.

Transaction summary

Financial terms of the deal, which was completed in January 2019 using cash reserves, were not disclosed. N-of-One is not expected to provide a material contribution to QIAGEN’s results in 2019.

About N-of-One

N-of-One is a Concord, Massachusetts, based privately held firm that began in 2008 as a cancer patient advocacy company and evolved into a molecular decision support company. N-of-One employs 41 people and eight practicing / treating oncologists as contractors. N-of-One has built a proprietary somatic cancer database with more than 125,000 patient samples, and they keep the rights to the anonymized data interpreted to grow their database. N-of-One is the leader in identifying patient-specific therapeutic options for precision medicine in oncology by leveraging its proprietary knowledge base and its team of oncologists and Ph.D. scientists to integrate molecular data from multiple tests. N-of-One’s solutions have provided therapeutic options, including clinical trials, for tens of thousands of patient cases across hundreds of cancer types. N-of-One partners with leading hospital systems, cancer centers, and commercial labs around the world.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers‘ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors‘ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).