In this section, we will break down next-generation sequencing, also known as NGS, including how it works, what the sensitivity of the test is, the pros and cons, and typical industry use and availability. 

How It Works

NGS analyzes DNA from bone marrow samples to identify and monitor unique dominant DNA sequences related to the individual patient’s myeloma. This "genetic fingerprint" allows for highly precise tracking of minimal residual disease (MRD) over time. NGS evaluates either bone marrow or peripheral blood for genetic evidence of myeloma cells.

Sensitivity

NGS can detect one cancer cell among 1 million normal cells, offering a sensitivity level of 10⁻⁶.

Pros

• Exceptionally high sensitivity for detecting even the smallest amounts of disease
• FDA-cleared for MRD detection in multiple myeloma (e.g., clonoSEQ®)
• Provides standardized, reliable results for tracking disease progression

Cons

• Requires an initial bone marrow sample to establish the patient’s genetic fingerprint
• May take longer to process results compared to other MRD tests
• Potential for lack of standardization

Industry Use

NGS is widely used in academic, community centers, and in clinical trials to monitor MRD. The FDA-cleared clonoSEQ® test by Adaptive Biotechnologies is the most recognized NGS assay for MRD detection in multiple myeloma. 

Pharmaceutical companies often integrate NGS-based MRD tracking into clinical trials to evaluate treatment effectiveness, especially in the development of novel therapies.

Availability

NGS testing is sent out for centralized, standardized testing to a single laboratory (Adaptive) And, clinical consultations are available to anyone needing more information regarding test results. NGS MRD is widely used in academic, community practice, and clinical trial settings since the test is performed by Adaptive Biotechnologies as a single, standardized, external lab.

• clonoSEQ® Patient Brochure
• clonoSEQ® Información para Pacientes