With over two decades of experience and over 400 Phase I-IV research studies completed, our experienced team of scientists and pathologists produces top-quality results through appropriate regulatory-compliant testing, evidenced by our stringent adherence to CAP/CLIA, ISO 15189 accreditation, and state licensures. Our committed team of project and data managers diligently ensures the timely delivery of data for complex trials to achieve patient recruitment targets and to support the preparation of a successful FDA submission packet, minimizing rejection risks while reducing overall study costs. With our main laboratory strategically located in East Tennessee, we partner with a trusted and accredited network of laboratories across the globe to support global studies, providing centralized and harmonized testing solutions.
Geneuity Clinical Research Services is a DBA wholly owned by Molecular Pathology Laboratory Inc (MPLN) that encompasses the following branches, providing services specifically tailored to our Biopharma and Clinical Research clients: Project Management, Data Management, and Commercial Operations. The MPLN laboratory performs all specimen handling and testing as a CAP/CLIA/ISO15189 accredited laboratory.
We offer targeted diagnostic approaches to fulfill the specific requirements of clinical trial studies. Our pathologists and scientific experts have extensive knowledge and experience in a wide range of therapeutic areas including solid tumor oncology, Non-Small Cell Lung Cancer, head and neck cancer, prostate cancer, breast cancer, ovarian cancer, dermatopathology, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Lymphocytic Leukemia, Multiple Myeloma, GI pathology (liver, NASH, cytology, urology), hematopathology, and more. We proudly have three board-certified hematopathologists on staff and scientific experts supporting infectious disease, immunology, inflammatory response, genetic and rare diseases, and musculoskeletal, pulmonary, and sepsis indications. We further expand our network of experts using our trusted KOL partners.
Our expert board-certified pathologists and scientists can help assess biomarkers and complex molecular pathology testing panels for patient recruitment, stratification, and ongoing safety monitoring. Our team also offers fully customizable validation services across all testing areas to support novel and exploratory biomarker assessments. Our combination of experience as a trusted CAP/CLIA laboratory and full-service validation capabilities provides a consultative and unique approach to clinical trials, including R&D and IVD study laboratory testing. Please browse our extensive testing menu to see our full selection of validated diagnostic and exploratory assays, or contact us today for questions about validation services.
Beyond informing drug target discovery, validation, and clinical development, it uncovers critical genetic markers that drive disease progression and influence individual treatment responses. This empowers healthcare professionals to create more precise, tailored treatment plans, optimizing medical management based on each patient’s genetic profile.
DNA Solutions – WGS*, WGMS*, WES*, TSO-500 Comp, Pillar OncoReveal
RNA Solutions – Total RNA-Seq*, RNA exome*, mRNA*
Liquid Biopsy Solutions – TSO-500 ctDNA, PGDx elio™ plasma complete*
*Offered through fully accredited partner laboratories.
Our advanced technology enables simultaneous visualization of single or multiple biomarkers within the same tissue section, delivering comprehensive insights and precise diagnostics. With unmatched expertise and cutting-edge technology, our team supports you in understanding complex tissue microenvironments, aiding patient stratification and treatment response prediction.