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 genetic mutations specific to myeloma cells. This "genetic fingerprint" allows for highly precise tracking of minimal residual disease (MRD) over time.

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-approved 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

Industry Use

NGS is widely used in academic centers and clinical trials to monitor MRD. The FDA-approved 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 is less commonly used in community oncology centers due to the need for specialized equipment and genetic analysis expertise. However, some centers may send samples to external specialized labs like Adaptive Biotechnologies for MRD testing.

• clonoSEQ® Patient Brochure
• clonoSEQ® Información para Pacientes