At the beginning of 2019, QIAGEN announced the acquisition of N-of-One, Inc., a molecular oncology decision support company that provides case-specific, expert-powered clinical NGS interpretation services and solutions.
We sat down with Sean Scott, QIAGEN’s Chief Business Officer and Vice President of Business Development for Clinical Genomics and Bioinformatics, to discuss QIAGEN’s plans for post-acquisition incorporation and what new value QIAGEN customers can expect.
How does the acquisition of N-of-One fit into QIAGEN’s clinical bioinformatics strategy?
Sean Scott: This acquisition represents a unique opportunity for QIAGEN and N-of-One to combine respective strengths to deliver the industry’s most robust portfolio of molecular oncology decision support solutions from one provider. 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), our platform for NGS analysis and interpretation. We are opening the door to real-world evidence (RWE) and creating new opportunities for supporting healthcare providers and payers.
What does the acquisition mean from a pharmaceutical company’s perspective?
Sean Scott: The addition of N-of-One’s MarkerMine database and commercial data rights creates an attractive and expandable link into RWE insights. N-of-One’s Genomic Insights and 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.
How does N-of-One differ from other molecular decision support providers?
Sean Scott: N-of-One is one of the best-known brands in molecular oncology decision support. It is well-established with labs, pharma companies, and payers, and N-of-One has been the solution-of-choice for leading diagnostic companies, such as Foundation Medicine. Unlike other providers, N-of-One employs a team of over 30 PhD scientists and oncologists to research and analyze each patient case, and in the process, N-of-One has amassed one of the most comprehensive resources of oncology clinical and scientific evidence in the industry with more than 125,000 anonymized patient samples.
How could real-world evidence and patient data impact clinical development program design?
Sean Scott: Today, all stakeholders in the healthcare spectrum—pharmaceutical developers, payers, regulators, physicians and patients—are putting their money on the collection and analysis of many different types of RWE as a key enabling strategy, to close critical gaps in knowledge, give physicians and patients broader access to therapies, and help payers realize the actual value of those therapies in improving health and reducing costs. While still at an early stage, RWE is becoming increasingly used to complement traditional RCT data to inform important healthcare decisions. This suggests that RWE will have a significant impact on the healthcare industry in the years to come.
We are excited to announce our acquisition N-of-One, Inc., a privately-held U.S. molecular decision support company and pioneer in clinical interpretation services for complex genomic data.
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.
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Day One kicked-off with numerous informational sessions, including talks on the role of AI in clinical decision-making, the importance of standardization for reimbursement, and the tremendous potential of genomic profiling in disease prevention, diagnosis, and treatment.
Dan Richards, Vice President of Biomedical Informatics at QIAGEN, spoke about the clinician's current challenge of curating all the evidence he or she needs to confidently sign-off on variant reports before they go to the prescribing physician. QIAGEN Clinical Insight (QCI) and N-of-One were featured as solutions providing options for either in-house curation with tailored workflows or on-demand curation services.
On Tuesday morning, the conversation continued with a panel hosted by Sean Scott, Chief Business Officer of Clinical Genomics and Bioinformatics at QIAGEN, that discussed the emergence and application of real-world evidence in the clinical setting, especially in precision diagnostics and clinical trial protocol design.
The panel consisted of Raju K Pillai, MD, Hematopathologist and Molecular Pathologist at City of Hope National Medical Center, James Hadfield, Director and Principal Diagnostic Scientist at AstraZeneca, and Sheryl Krevsky Elkin, Chief Scientific Officer of N-of-One.
Also on Tuesday morning, Mary Napier, Associate Director of NGS Strategy at QIAGEN, gave a timely talk on how diagnostic labs and pharma companies can gain a comprehensive understanding of tumor mutational burden signature by implementing our new QIAseq Tumor Mutational Burden panel.
What does she mean by "comprehensive"?
Find out here!
Thank you to everyone who visited the QIAGEN booth, we truly enjoyed talking to all of you about the industry challenges, and changes you see happening now and in the future.
See you at our next event:
Advances in Genome Biology and Technology (AGBT) 2019 in Marco Island, Florida!
February 27th - March 2nd
Want to know more about our clinical solutions and real-world evidence?
