FAQ – Minimal Residual Disease (MRD) Testing – HPH MRD

Minimal residual disease (MRD) testing is used to detect very small numbers of cancer cells that may persist in the body after treatment. MRD tests detect tiny DNA fragments of genetic material released by cancer cells into the bloodstream. These fragments are called circulating tumor DNA (ctDNA). This information can be applied by clinicians for following purposes: To assess a patient’s risk of recurrence without further therapy, to identify patients who are more likely to benefit from additional treatment, to monitor disease status during ongoing therapy, to detect patients with cancer recurrence following definitive treatment.

MRD testing enables earlier detection of residual, recurrent, or resistant cancer cells than traditional detection methods. This allows clinicians to make treatment decisions earlier, when the tumor burden is low, improving the potential for successful outcomes.

CtDNA has a very short half-life of about 2 hours in the blood circulation and is thus a very direct biomarker of tumor presence. Detecting and analyzing ctDNA provides a minimally invasive approach to identify residual disease. A blood-based liquid biopsy can reveal tumor cells much earlier than imaging, improving the likelihood of a successful treatment intervention.

HPH MRD is a blood-based liquid biopsy test offered by the MVZ HPH Institute for Pathology and Hematopathology Hamburg. It uses a tumor-informed approach for highly sensitive and specific detection of circulating tumor DNA (ctDNA). The process begins with whole-genome sequencing (WGS) of the patient’s tumor tissue and a matched normal blood sample to identify patient-specific somatic mutations. Based on the WGS results, a personalized mutation panel is designed for each patient. A next-generation sequencing (NGS) assay is then used to detect and monitor ctDNA in plasma, enabling the identification of residual, recurrent, or treatment-resistant disease.

HPH MRD offers several key advantages: High sensitivity and specificity for accurate MRD detection, comprehensive whole-genome sequencing (WGS) approach, personalized mutation tracking based on tumor-specific genetic signatures, fast turnaround times for timely clinical decision-making, accredited laboratory with highest quality standards, expert team with extensive experience in molecular diagnostics.

HPH MRD uses an advanced, highly optimized form of the Safe-SeqS chemistry (Haystack MRD technology). Its patented error-correction technology confirms variants on both DNA strands, delivering a robust double-verification process for a higher standard of diagnostic accuracy and confident clinical decision-making.

Coverage for HPH MRD testing may vary depending on the health insurance provider and specific clinical indication. We recommend contacting your insurance provider or our team to discuss coverage options for your specific case.

Yes, our platform can support patient stratification for enrolment in neoadjuvant and adjuvant settings, as well as in second-line therapy trials. It can also be used to monitor therapeutic efficacy, potentially delivering significant time and cost savings.

Designing the personalized HPH MRD assay requires a formalin-fixed, paraffin-embedded tumor sample (or in some cases, a biopsy sample) and an initial blood draw (3x 9 mL, Streck Tube). All subsequent MRD testing is performed using blood draws only (3x 9 mL, Streck Tube).

The amount of tissue required depends on the sample type. Both biopsy and resection samples can be used, provided they contain sufficient tumor tissue for whole-genome sequencing. Our team can provide specific guidance on sample requirements based on your case.

Standard methods for tumor sample collection are suitable, including surgical resection, core needle biopsy, and fine-needle aspiration. The sample should be properly preserved and sent according to our shipping guidelines.

Turnaround times for HPH MRD testing vary depending on the stage of testing. Initial tumor profiling typically takes 3-4 weeks, while subsequent blood sample analysis for MRD monitoring typically takes approximately 10 days.

HPH MRD can track up to 50 mutations simultaneously, as the test is based on whole-genome sequencing which provides comprehensive coverage of the tumor's genetic profile. The specific number of mutations tracked is personalized based on each patient's tumor characteristics.

Yes, our laboratory maintains appropriate accreditations and certifications. We adhere to the highest quality standards for molecular diagnostics and follow all relevant regulatory requirements.

A WGS report will not be provided and WGS data are only generated to guide the variant selection for manufacturing the personalized test.

If a tumor sample fails WGS analysis, our team will contact you to discuss alternative approaches. This may include requesting an additional sample or exploring alternative testing methods based on sample quality and availability.

Cell-free DNA (cfDNA) refers to all DNA fragments found in the bloodstream, regardless of their origin. Circulating tumor DNA (ctDNA) is a subset of cfDNA that specifically originates from tumor cells. HPH MRD focuses on detecting ctDNA, which provides tumor-specific information.

The DYNAMIC study is a clinical research study investigating the use of MRD testing in patient management. For specific information about the DYNAMIC study and its findings, please contact our team or refer to relevant clinical publications.