Ultra-Sensitive Minimal Residual Disease (MRD) Evaluation Services for CAR Therapy

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Despite the transformative potential of CAR therapies, clinical success is often hindered by the inability to reliably detect residual malignant cells at extremely low abundance, leading to delayed intervention and ambiguous prognostic stratification. To address this critical gap, we offer ultra-sensitive minimal residual disease (MRD) evaluation services specifically designed for CAR-T and CAR-NK cell therapy programs. Our service integrates high-parameter flow cytometry and next-generation sequencing with custom-designed CAR-targeted molecular barcodes, enabling quantification down to individual cell levels.

Introduction

CAR-T cell therapy has revolutionized the treatment of hematological malignancies by harnessing engineered T cells to selectively eliminate tumor cells, yet achieving durable remission remains a formidable challenge for a substantial proportion of patients. Minimal residual disease (MRD), defined as the persistence of submicroscopic malignant cells below conventional detection thresholds, has emerged as the most reliable prognostic biomarker, with sustained MRD negativity strongly correlating with prolonged progression-free and overall survival across multiple disease contexts. The precise and ultrasensitive evaluation of MRD following CAR-T infusion is therefore of paramount clinical importance, as it enables early risk stratification, facilitates timely therapeutic intervention, and provides a dynamic molecular compass for guiding personalized treatment decisions to preempt overt relapse

Fig.1 A pathway for the MRD-directed surveillance and intervention in early-stage NSCLC. (OA Literature) Fig.1 An operational framework that utilizes MRD to direct the treatment of early-stage NSCLC.¹

Our Service

Our Ultra-Sensitive MRD Evaluation Service for CAR Therapy leverages next-generation sequencing and digital PCR to detect trace cancer cells at high sensitivity level. By precisely tracking therapeutic efficacy, clonal evolution, and disease recurrence, we provide high-resolution kinetic reports and robust raw data to accelerate cellular therapy development and optimize patient management.

What We Can Offer

We offer advanced MRD evaluation tailored for CAR‑T cell therapies, leveraging high‑sensitivity assays to detect residual malignant cells well below conventional thresholds. Our platform enables precise risk stratification, early relapse prediction, and longitudinal treatment response monitoring, empowering actionable data to optimize patient management and therapeutic outcomes.

Our signature NGS‑Based Companion Ultra‑Sensitive MRD Tracking service integrates next‑generation sequencing with proprietary error‑suppression algorithms to track clonal rearrangements and CAR‑engineered cells simultaneously. This dual‑readout approach delivers unparalleled sensitivity and specificity, distinguishing true residual disease from bystander signals, while providing a dynamic molecular compass for real‑time intervention decisions throughout the CAR‑T treatment continuum.

Our Service Process

Required Starting Materials:

Patient clinical samples: peripheral blood, cryopreserved cells, or genomic DNA, etc.
Baseline samples.
Accompanying clinical data.

Key Steps:

Workflow of NGS-based companion ultra-sensitive MRD tracking for CAR therapies at Creative Biolabs. (Creative Biolabs Original)

Final Deliverables:

Raw data.
Analytical test report.

Key Advantages

CARtherapy tailored: Exclusively calibrated for CAR-T and CAR-NK products, our assay distinctly discriminates CAR positive effectors from residual tumor populations, effectively eliminating false positive signals.
Early relapse forecasting: Ultra-sensitive tracking enables molecular level recurrence alerts weeks to months ahead of imaging or routine biopsy, offering a crucial therapeutic window for preemptive clinical action.
Rapid, standardized workflows: We deliver uniform testing reports alongside streamlined sample processing, facilitating real time response monitoring and on the fly clinical decision making throughout the treatment course.
Broad and customizable targeting: Our system accommodates major clinically relevant CAR antigens and supports tailored assay development for novel or investigational targets upon request.

FAQ

Q1: What types of starting materials are required for the assay?

A1: We accept bone marrow aspirates, peripheral blood, cryopreserved PBMCs, or extracted genomic DNA. For personalized assay design, a baseline/diagnostic tumor sample or predefined genetic marker data is highly recommended.

Q2: Can this service track CAR-T cell persistence and MRD simultaneously?

A2: Yes. We offer co-testing options that simultaneously monitor CAR-T transgene copy numbers or cell frequencies alongside MRD tracking, providing a comprehensive kinetic correlation to evaluate CAR-T cellular kinetics and anti-tumor efficacy.

Why Choose Us?

We combine individual cell detection sensitivity with CAR‑tailored assay design, delivering earlier relapse alerts than conventional methods. Our standardized workflows ensure rapid turnaround, while flexible customization accommodates both common and novel targets. Backed by dedicated scientific support, we provide actionable data that empowers precise clinical decisions, transforming MRD monitoring from a passive readout into a proactive therapeutic guide.

Customer Reviews

"We chose this service for its ability to simultaneously track CAR-T persistence and MRD kinetics. The comprehensive analytical reports and clean, regulatory-compliant raw data seamlessly integrated into our IND submission package, saving us weeks of documentation time." M* V*, PhD.

"For our complex lymphoma study, standard MRD assays were insufficient. The team’s ability to design custom, patient-specific NGS primers based on baseline diagnostic data gave us the precise tracking we needed to map out clonal evolution post-infusion." Prof. S* J*.

How to contact us?

Our scientific team is ready to discuss your specific CAR therapy project, from early‑phase development to post‑infusion monitoring. Whether you need assay customization, technical consultation, or a tailored pricing plan, we invite you to reach out through our website or dedicated inquiry portal. Tell us your target, your sample type, and your sensitivity requirements – we will respond with a feasibility assessment and a preliminary proposal.

Reference

Boukouris, Aristeidis E et al. "A comprehensive overview of minimal residual disease in the management of early-stage and locally advanced non-small cell lung cancer." NPJ precision oncology vol. 9,1 178. Distributed under Open Access License CC BY 4.0, without modification. https://doi.org/10.1038/s41698-025-00984-9.

All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.