On January 8, 2024 ConcertAI, LLC, a leading oncology real-world evidence data and AI technology company, and NeoGenomics, Inc., a leading oncology testing services company, reported a broad collaboration to advance large-scale hematological research solution to investigate real-world clinical practice and outcomes in hematological malignancies (Press release, NeoGenomics Laboratories, JAN 8, 2024, View Source;generative-ai-solutions-at-ash-2023-302028062.html [SID1234639118]).
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Few diseases are as complex as hematological malignancies. The number of alternative treatments considered for patients at different points throughout their care is more varied and individualized than what is seen in diagnosis and management of solid tumors. Hematological malignancies require surveillance of patients over multiple time periods with numerous clinical and diagnostic measures to assess sustained response to treatment or relapse.
Combining ConcertAI’s longitudinal clinical data with NeoGenomics’ comprehensive biomarkers derived from hundreds of hematological tests, we are able to establish a robust and definitive real-world evidence (RWE) hematology solution. The collaboration advances molecular and genetic data solutions for the entire drug development lifecycle, from early clinical development planning to post-approval epidemiological studies. The scale and volume of the combined dataset, which covers over one million patient lives across over 1,000 oncology clinics, provides coverage of key biomarkers throughout the entire patient treatment journey and across multiple lines of therapy, which enables high-value research and quality of care insights. This is the first population-scale hematology data set, which is both large and broad enough to minimize selection bias, to offer an actionable representation of the hematological prevalent disease in the US. The multi-modal combination of Electronic Medical Record (EMR) and rich biomarker data allows for the latest causal inference methodologies, increasingly preferred by the U.S. FDA and other regulatory bodies, and clinical AI methodologies with assurance of high representativeness and generalizability.
"ConcertAI has spent the last three years with biopharma researchers, medical societies, patient advocacy groups, and academic teams to define requirements for truly definitive, insight-enabling research solutions for hematological malignancies," said Jeff Elton, PhD, CEO of ConcertAI. "We did this with the collective goal of having a decade or more of data, richness, consistency in biomarker coverage and the ability to integrate across clinical data and diagnostic modalities. NeoGenomics captures the majority of all U.S. hematologic malignancy testing being sent out to a reference laboratory. It was obvious to both teams that combining our data and capabilities could solve the legacy challenges of depth, breadth, and limited longitudinality."
With rich cytogenetics, morphology, flow cytometry, FISH, and molecular hematological data, this collaboration now has the potential to apply the latest Generative Artificial Intelligence and other complementary approaches that are historically limited by data set sizes and lack of standardization. Hematological diseases can be stable under treatment for years and then enter a period of non-response and relapse. New AI approaches offer the potential to define predictable patterns linked to specific biomarker patterns, aligned to different treatment approaches, and directly associated with outcomes, which can inform new therapeutic programs, clinical trial designs, and treatment strategies.
"We are excited to see the collaboration produce a rich and meaningful dataset to fuel life science research, clinical trial planning and real-world data application," said Lindsey Gasparini, Vice President of Informatics at NeoGenomics. "Our expansive footprint in hematologic testing will enable an important view into clinical work up, diagnosis, and monitoring through longitudinal and multi-modal testing for the community oncologist. ConcertAI has an impressive collection of research-grade clinical data in oncology and hematology, and the power in linking that with the depth and breadth of NeoGenomics data is transformational," Gasparini continued.
The companies will be launching a hematology-focused collaborative version of ConcertAI’s Clinical Trial Optimization solution later in Q1, supporting study design and optimizing all aspects of trial planning, with multiple clinical development initiatives planned.