FAQs

Frequently Asked Questions

Straight answers on the xCellSense® platform, including sample logistics, study design, data, IP, and getting started — for biotech and pharma teams developing hematologic-oncology therapies.

Platform & Technology

What makes functional ex vivo drug sensitivity testing more representative of patient biology than cell-line or mouse models?

Patient-derived primary cells retain the genetic heterogeneity, microenvironmental context, and resistance mechanisms of the actual tumor. Cell lines are extensively passaged and lose features that drive drug response. xCellSense® tests compounds in fresh patient samples that preserve their original immunophenotypic and genomic characteristics, generating data that more closely reflect the patient’s disease biology.

How does xCellSense® differ from other patient-derived testing platforms?

xCellSense® is purpose-built for hematologic malignancies. Our proprietary Optimum Media preserves the viability of primary blood-cancer cells after biopsy, whereas conventional media fail within days — a prerequisite for reproducible functional testing. We integrate drug sensitivity, multiparameter flow cytometry, optional NGS, and machine-learning analytics into a single workflow, with protocols specialized for blood-cancer cell handling, culture, and readout.

What quality standards does ImpriMed maintain?

ImpriMed operates two laboratories: a Silicon Valley lab accredited to ISO 17025 (A2LA) and a Seoul lab certified under KGMP and holding an IVD Medical Device Manufacturing License. CRO services are provided on a Research Use Only basis.

Which drug modalities are supported by your platform?

The platform supports biologics with direct cytotoxic effects, small molecules, peptides, oligonucleotides, enzymes, ADCs, DACs, bispecifics, and targeted degraders. For T-cell-engaging or immunomodulatory candidates, we incorporate relevant effector-cell populations and immune-mediated cytotoxicity readouts, as confirmed on a per-program basis. Cell and gene therapies are not supported as test articles. Contact us to confirm fit for your specific approach.

Sample Requirements & Logistics

How many patient samples are needed for a typical study?

Sample size depends on your objectives. For lead selection comparing 2–3 drug candidates, 10–30 samples typically capture biological variability. For biomarker discovery and patient segmentation, 30–50 samples provide sufficient power to identify responder subgroups. We recommend determining the sample size during the study design consultation.

Do you provide sample procurement, or do we supply samples?

Both. ImpriMed has established relationships with sample vendors and academic medical centers in the US and Korea. It can procure samples on your behalf with appropriate IRB approval and patient consent, or work with your banked repositories or clinical trial materials. All procurement complies with applicable ethical and regulatory requirements.

How are samples shipped, and what is the turnaround time?

Fresh samples ship at room temperature in our specialized transport media via overnight courier and remain viable for 24–48 hours. xCellSense® is designed for fast turnaround; we provide a study-specific timeline in your proposal, scaled to the number of compounds and selected readouts.

Study Design & Services

Can you help design the study, or do we need a complete protocol?

A full study design consultation is included in the service. We help define objectives, select controls, set dose ranges, choose endpoints, and establish the statistical analysis plan — drawing on extensive drug-development experience to maximize each study's value.

What controls and comparators do you typically include?

We routinely include indication-relevant standard-of-care comparators (for example, cytarabine and venetoclax for AML; bortezomib and lenalidomide for MM), vehicle controls, and, when useful, reference compounds from the same class — contextualizing your candidate against established therapies.

Can you test drug combinations and evaluate synergy?

Yes — combination testing is a core capability. We run dose matrices, quantify synergy using Bliss independence, Loewe additivity, ZIP, and HSA models for two-drug or more complex regimens, and identify which patient subgroups benefit most from combination approaches.

Do you provide genomic and transcriptomic profiling of samples?

Yes — targeted NGS panels, whole-exome and whole-genome sequencing, and bulk and single-cell RNA-seq with pathway analysis, clustering, and UMAP visualization. These integrate with drug-sensitivity data to surface predictive biomarkers and mechanistic hypotheses.

Can you analyze drug response in specific cell populations?

Yes. Using flow cytometry, we assess drug sensitivity in defined immunophenotypic populations — for example, CD34+ leukemic stem cells, lymphoma subsets, or plasma-cell compartments — to clarify the mechanism of action (MoA) and identify which cellular compartments are most sensitive to your compound(s).

Data & Analysis

What specific metrics and endpoints do you provide?

Individual patient dose-response curves; IC₅₀, area under the curve (AUC), and maximum effect (Eₘₐₓ); and statistical comparisons across patients and drugs. We classify patients as responders or non-responders using predefined thresholds and provide efficacy distributions; additional endpoints can be customized to your program.

How do you define responders versus non-responders?

Definitions are tailored to your program — commonly an IC₅₀ below a set threshold, an AUC indicating substantial cell kill, or a percentage of maximum effect. We establish clinically relevant cutoffs with you during study design.

What biomarker analyses are included?

Our ML-powered analytics link drug response to biomarkers — such as genetic mutations, immunophenotypes, and gene expression signatures — highlighting features that distinguish responders from non-responders and suggesting potential predictive biomarkers. Additional packages provide pathway enrichment analysis and insights into mechanistic relationships across multiple omic solutions.

Do you provide raw data or only analyzed results?

Both. Final reports include ready figures, statistical analyses, and interpretations, along with all relevant raw data — flow cytometry files (FCS) and sequencing data (FASTQ/BAM/VCF), when applicable.

Can the data support regulatory submissions?

Services are for Research Use Only (RUO). We provide detailed study reports that include complete methodology and QC documentation. If you anticipate using the data in a regulatory submission, raise this during study design so we can assess feasibility and determine appropriate documentation standards.

Commercial & Partnership

What is the typical timeline from initiation to results?

Engagements progress through study design, sample procurement (or use of your banked material), testing and analysis, and reporting. We aim for a fast turnaround and provide a study-specific timeline in your proposal; urgent programs can be prioritized.

Can we establish a long-term partnership or a platform access agreement?

Yes. For sponsors with active hematologic-oncology pipelines, we offer multi-study agreements, preferred commercial terms, dedicated project management, and priority access to our sample network.

How do you handle intellectual property and confidentiality?

All client compounds and data are handled with strict confidentiality. We claim no IP rights in your compounds, data, or resulting insights — they remain your proprietary information. We accommodate specific requirements, including materials transfer agreements, master service agreements, and invention-assignment terms.

What happens if the results are negative or inconclusive?

You receive honest, objective data either way. A clear negative is valuable — it prevents the costly advancement of an ineffective candidate. If a result is inconclusive for technical (not biological) reasons, we work with you to optimize conditions or redesign the study. The goal is reliable, decision-grade data that supports sound scientific decisions.

Can the data support regulatory submissions?

Services are for Research Use Only (RUO). We provide detailed study reports that include complete methodology and QC documentation. If you anticipate using the data in a regulatory submission, raise this during study design so we can assess feasibility and determine appropriate documentation standards.

Getting Started

What information do you need to provide a detailed proposal?

(1) A brief description of your compound(s) and mechanism of action, (2) target indication(s), (3) stage of development, (4) the key questions you need answered, (5) timeline requirements, and (6) whether you will supply samples or require procurement. A scientist responds within two business days, with a tailored proposal to follow.

How do we initiate a project?

Contact us via the request form or email. We schedule an initial call to understand your program, then send a tailored proposal outlining the scope, study design, and timeline. Once agreed, we execute the necessary agreements (CDA, MSA) and begin promptly.

Still Have Questions?

Our scientific team is ready to discuss your program and how xCellSense® can accelerate your hematology-oncology drug development. Email cro@imprimedicine.com or click the button below — we respond within two business days.