Labs and diagnostics firms are racing to adapt after the National Comprehensive Cancer Network (NCCN) set a new bar for minimal residual disease (MRD) testing in multiple myeloma: 10−6 sensitivity. That means finding a single cancer cell among a million. The shift lands squarely on the desks of test developers and clinical labs, who now face pressure to deliver this level of precision in routine cancer monitoring.
The September 2026 NCCN update did more than tweak technical specs. MRD testing now extends to new time points, including during maintenance therapy and after advanced treatments like CAR T-cell therapy. This expansion is already fueling demand for high-sensitivity molecular diagnostics and repeat testing across the patient timeline. A recent analysis shows NCCN now calls for annual MRD checks during maintenance and after late-line therapies, including CAR-T, with 10−6 as the preferred sensitivity—roughly one malignant cell in a million normal cells.
The International Myeloma Society in 2026 introduced a consensus definition of myeloma cure: at least five years off therapy, complete remission by IMWG criteria, and serial NGS-MRD negativity confirmed by four consecutive assessments.
Market Acceleration and Competitive Dynamics
Diagnostics companies are scrambling for position. Adaptive Biotechnologies' clonoSEQ appears by name in the new NCCN guidance. Natera's Signatera CDx won FDA approval in May 2026 for detecting molecular residual disease after surgery in muscle-invasive bladder cancer. ARUP Laboratories and Myriad Genetics are pushing their own platforms, while Guardant Health is moving fast to capture share. The guidelines now explicitly mention bone marrow NGS testing with FDA-cleared assays like clonoSEQ or multiparameter flow cytometry, as detailed in a corporate report cited by Adaptive Biotechnologies.
Market projections are climbing fast. DataM Intelligence pegs the global MRD testing market at US$ 1.68 billion in 2025, with forecasts hitting US$ 8.47 billion by 2035. That’s a 17.4% compound annual growth rate from 2026 to 2035. Blood cancers account for 64% of the market, cancer centers drive 36% of end-user demand, and North America leads with a 39% regional share.
Regulatory and commercial moves are reshaping the field. The FDA has issued draft guidance on multiple myeloma. Natera’s Signatera CDx has cleared approval. Foundation Medicine rolled out FoundationOne MRD. International registry proposals are surfacing. Mergers and acquisitions are picking up speed: CareDx bought Naveris, Tempus AI is acquiring Personalis, and Roche is taking over SAGA Diagnostics. The sector is consolidating fast.
Current IMWG guidelines allow for bone marrow MRD assessment by either NGS or flow cytometry, but discrepancies between these technologies can complicate interpretation and standardization.
Technological Shifts and Clinical Integration
Next-generation sequencing (NGS) is gaining ground as MRD testing moves into solid tumors. The market is no longer just about blood cancers. Applications now reach leukemia, lymphoma, multiple myeloma, and a growing roster of solid tumors. PCR, flow cytometry, and circulating tumor DNA (ctDNA) assays are all in the mix, but the push for validated, high-sensitivity assays is relentless.
Clinicians are leaning harder on MRD results, with repeat testing and long-term monitoring now routine. Still, as a recent clinical commentary points out, a negative MRD result only means no disease was found at the test’s sensitivity—not proof of cure. Experts warn against using MRD status as the only reason to change therapy. Multiple negative results carry more weight for tracking response durability.
For those watching the collision of advanced diagnostics and cancer therapy, the current MRD testing overhaul echoes earlier breakthroughs that changed how tumors are found and targeted.
NCCN’s 10−6 sensitivity benchmark is now a market driver and a clinical requirement. MRD testing is becoming central to treatment decisions and relapse monitoring. Only companies that pair technical rigor with clinical proof will keep pace. The era of fuzzy detection thresholds has ended. Molecular clarity at scale is now the industry’s baseline.
