Disease State Biospecimens for Drug Development

MT Group delivers biospecimens with comprehensive clinical annotation. Data fields that may be provided include:

• Demographics: Age, sex, race, ethnicity
• Medical History: Diagnoses, comorbidities
• Treatment History: Therapeutic regimens, surgeries, dosing, lines of therapy
• Diagnosis/Pathology: Clinical diagnosis, path reports or summaries, tumor grade and stage, histology
• Disease-Specific Biomarkers: e.g., ER/PR/HER2 for breast cancer; MSS/MSI for colorectal cancer; PDL-1 status, if available
• Lifestyle Factors: Smoking status, alcohol use, BMI
• Lab Values: Relevant clinical laboratory results from standard of care
• Outcomes & Survival: Treatment response, relapse, and survival data

Serum vs. Plasma Comparison

Collection process:

• Serum: Whole blood collected without anticoagulant → allowed to clot (~30 min) → centrifuged → supernatant = serum.
• Plasma: Whole blood collected into anticoagulant tube → centrifuged immediately → supernatant above RBC pellet = plasma.

Analyte stability and assay performance vary between matrices; the right choice depends on your downstream application. MT Group collects both as part of our blood sample offerings.

MT Group has experience collecting biospecimens across a wide range of disease states spanning oncology, autoimmune and inflammatory diseases, metabolic disorders, cardiovascular conditions, infectious diseases, pulmonary diseases, and many other therapeutic areas. While our particular strengths lie in solid tumors and autoimmune diseases, our established site network enables collections across virtually any disease state where patients are seen in clinical settings. We conduct thorough feasibility assessments to determine collection viability and provide realistic enrollment projections for your specific disease population of interest.

In prospective collections, MT Group can accommodate highly granular inclusion and exclusion criteria tailored to your research objectives. Specifications can include disease severity scoring thresholds, specific treatment histories including washout periods and lines of therapy, comorbidity exclusions defined broadly or narrowly, biomarker status requirements, disease duration parameters, and standard demographic filters. This precision ensures specimens match the exact clinical and biological characteristics your study requires, eliminating compromises necessary with banked samples.

Comprehensive clinical documentation that accompanies disease biospecimens can include patient demographics, complete diagnosis with disease stage or severity scores, detailed treatment history (current and prior medications with dosing and duration), relevant comorbidities, laboratory values (disease-specific markers, routine chemistries), imaging findings when applicable, surgical pathology reports, and longitudinal outcome data when collected. MT Group customizes case report forms to capture specific data elements most relevant to your research. Essentially any information collected as part of standard clinical care can be provided, and non-standard-of-care data collection can often be arranged.

Treatment-naïve collections from patients who have never received systemic therapies are feasible but enrollment can be more limited based on new patients presenting at our sites. Treatment washout collections, where subjects discontinue medications for a specified period before specimen collection, are commonly performed instead. MT Group works with you to determine the most appropriate baseline collection strategy balancing scientific objectives with enrollment feasibility.

Yes, longitudinal collections tracking patients throughout their disease course and treatment journey are a core strength of MT Group. We achieve 90%+ subject retention rates by coordinating collections with standard-of-care clinical visits, maintaining proactive communication with sites and subjects, and implementing quality project management practices. Longitudinal collections enable tracking of disease progression, therapeutic response, biomarker evolution, and clinical outcomes over time, providing comprehensive datasets for robust research analyses.

Prospective disease collections typically begin 2-4 weeks after receiving a purchase order. During this period, MT Group develops collection SOPs, assembles study-specific material kits, and onboards collection sites. Nearly all collections fit under established umbrella IRB protocols, eliminating delays for additional approvals. Actual enrollment timelines depend on disease prevalence, eligibility criteria specificity, disease severity requirements, and treatment status specifications.

Yes, MT Group operates a global site network enabling disease biospecimen collections internationally. Fresh tissue requiring overnight delivery is limited to US locations, but frozen tissue, FFPE tissue, and blood specimens can be collected internationally and shipped to global destinations. International collections often provide access to larger patient populations and faster enrollment than US-only studies.

MT Group's rigorous enrollment protocols and site training minimize screen failures, but occasionally subjects may not fully meet criteria after enrollment or tissue may not be released by pathology due to quality issues. In these cases, specimens are not shipped and you are not charged. We work to identify and enroll replacement subjects to meet study targets. Our feasibility assessments account for expected screen failure rates to provide realistic enrollment projections.

For prospective disease biospecimen collections, MT Group typically requires a minimum order of 10 subjects due to significant study startup investments including protocol development, IRB coordination, site activation, and training. This minimum ensures efficient project execution while maintaining our quality standards.