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In late 2018, QIAGEN, a leading molecular diagnostics and precision medicine company, acquired molecular oncology decision support company N-of-One. This move enabled QIAGEN to enhance its sample-to-insight solution offering with its clinical laboratory customers in molecular oncology testing from assay design to test interpretation—and to develop a new real-world data (RWD)-based solution offering for pharma and payers spanning basic research and discovery, through clinical development, to the development of companion diagnostic (CDx) products for approved therapies.

“The vision was to bring together N-of-One’s “expert-based molecular oncology decision support services together with QIAGEN’s existing evidence-based, clinical decision support software–based solutions to better meet our customer’s evolving needs,” says Sean Scott, VP, Business Development of QIAGEN Bioinformatics. QIAGEN can now offer its laboratory customers either its QIAGEN Clinical Insight (QCI) Interpret for Somatic Cancer clinical decision support software or QCI Precision Insights service-based interpretation capabilities, powered by N-of-One, or a combination of the two configured to each customer’s specific needs and challenges. “With this acquisition, QIAGEN enhances its software-based molecular oncology decision support solutions with N-of-One’s expert-based, on-demand curation and interpretation services, and RWD assets,” says Scott.

QIAGEN recently reached a milestone where its customers have analyzed and interpreted more than one million patient test cases through its clinical decision support software, and the addition of the N-of-One interpretation service will accelerate the growth of the sample volume where RWD derived from these cases can be used to power improved enhanced analytics with QIAGEN’s health care organization (HCO), pharma, and payer customers. QIAGEN’s goal here is to enable its customers to generate Real-World Insights (RWIs) from these increasingly large data sets.

“The benefit of the QIAGEN acquisition to the N-of-One customers is that these customers now have access to QIAGEN’s global presence, broader sample-to-insight solutions offerings, expertise in molecular diagnostics, extended support in hereditary-germline indication testing, and increased R&D investments. Many of N-of-One’s laboratory oncology testing customers are providing not only clinical testing services, but also pharma research program and trial support services and considering, CDx and IVD product support—all of which QIAGEN can assist them with,” says Scott.

Better together

About five years ago, QIAGEN established a molecular oncology franchise that now offers complete sample-to-insight solutions, ranging from target discovery and lab testing and variant interpretation through CDx product development for investigational compounds and approved drugs. Through the acquisition, QIAGEN has expanded its curated database with over 150,000 patient cases across more than 1,000 cancer types, 140,000 unique variants, and 1,900 genes—all part of N-of-One’s Genomic Insights Solution, further strengthening its clinical interpretation and reporting capabilities.

“Genomics Insights is an RWD-based solution offering that QIAGEN has recently developed for select pharma research and discovery applications such as biomarker and indication selection, prospective patient cohort stratification, trial protocol and eligibility criteria design and patient-to-trial matching and accrual forecasting, providers in support of genomics-guided precision medicine programs and clinical decision support and treatment pathway compliance, and payers for evidence-based reimbursement decision making. Overall, Genomics Insights, initially for oncology, can enable pharma and providers to advance their precision medicine development and application efforts across the drug development and clinical decision support continuum.”

In fact, the value of Genomic Insights, powered by N-of-One, was demonstrated when N-of-One collaborated with a global top 10 pharmaceutical company to help inform their development of a CDx to identify cancer patients most likely to respond to a targeted oncology therapy in their late-stage pipeline. Such CDx that can successfully identify the patients most likely to benefit from a treatment is crucial to the delivery of care in the era of precision medicine. Based on data derived from its clinical interpretation business, N-of-One reported the prevalence data for specific gene alterations in the cancer types of interest as well as gene variant classification and real-world cancer type data.

QIAGEN brings expertise in diagnostic development to the table, having had multiple successes in bringing CDx through approval by the U.S. Food and Drug Administration (FDA).  For example, QIAGEN’s recently approved therascreen® FGFR RGQ RT-PCR Kit and therascreen PIK3CA RGQ PCR Kit help clinicians identify patients eligible for treatment with newly licensed FGFR and PI3Kinase inhibitor drugs, respectively. The combined power of QIAGEN’s CDx development and Genomic Insights services can ultimately lead to the creation of more, and better CDx.

“N-of-One and QIAGEN are helping to take cancer drug development to the next level by aligning the real-world data and comprehensive analyses needed to support biomarker and indication selection for trial stratification and CDx labeling with the superior technical design, regulatory expertise, and manufacturing excellence that are required to deliver the precision CDx that will identify the patients who will derive the most benefit from the targeted therapies,” says Sheryl Krevsky Elkin, PhD, Chief Scientific Officer at N-of-One, a QIAGEN company.

The solutions Genomics Insights offers go beyond informing biomarker selection and CDx development, with plans to expand into other areas such as the analyses of biomarkers for immunotherapy.

Real-world insights, now

QIAGEN, with the addition of N-of-One, can now offer RWIs based on N-of-One’s real-world database of over 150,000 cancer cases, providing value across the spectrum of drug development. Although significant promise is associated with the use of real-world evidence (RWE) in accelerating targeted therapy development, highly valuable RWIs to support critical decision points can be derived from RWD.

For example, during biomarker selection and drug indication evaluation, RWD can provide insights beyond the prevalence of a biomarker for a drug. “The actual numbers of patients with a cancer type out in the real world who are positive for the biomarker alteration of interest is different than the prevalence of the alteration in that cancer type,” says Elkin. “This is because in reality, there may be a higher prevalence of the cancer type itself or a cancer type might be tested more frequently.”

During trial cohort and CDx design, RWD can provide insights into the use of different assays in the real world. “It’s critical to know real-world use of an assay to get a fuller picture of any barriers a drug may face once in the real-world,” says Elkin. “For example, if an assay is not widely available or routinely performed, that may hinder a drug from reaching its target patient population.”

N-of-One’s gene variant classification of cell lines or trial subjects is important for analyzing mutational profiles associated with response or resistance to an experimental drug. But the subsequent question is, how often are those profiles seen in the real-world? “Using our real-world data, we are able to determine the prevalence of these molecular profiles in a cancer population,” explains Elkin.

Another stage during which RWD can be valuable is clinical trial accrual, which can be challenging when multiple sites are involved. “Understanding the monthly frequency at which alterations are discovered in, and the geographic locations of, real-world cases can support trial enrollment needs,” says Elkin. For example, RWD can guide trial organizational decisions, such as how many trial sites should be opened and where.

The future is the real-world

Having access to RWD to generate RWIs is of increasing importance in drug development, particularly for targeted therapies and immunotherapies. QIAGEN will continue to develop and partner to assemble broader RWD resources, to enable customers to obtain better RWIs, with greater real-world impact.

“For example, we’ll be working with our HCO customers to link their genomic profiling data with treatment decisions and outcomes,” says Scott. “We’ll also be partnering with clinical research data networks to enrich clinical data with molecular profiling data to support drug development programs and trial design.”

 

Contact N-of-One, a QIAGEN Company, to learn more about how QIAGEN’s acquisition of N-of-One can help support drug developers and the precision oncology development lifecycle: n-of-one.com.

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