How a first-in-class NGS diagnostics company built clinical belief in a new category of cancer testing

MRD is the small population of cancer cells that survives treatment, below the detection limit of standard response assessment. clonoSEQ uses multiplex PCR and next-generation sequencing to identify the DNA signature of a patient's malignant clone at diagnosis, then tracks those exact sequences in later samples, detecting one cancer cell among a million.

It reframes what response means: not whether disease is visible, but how much remains. In 2018 it became the first FDA-cleared NGS MRD assay for any lymphoid cancer.

The science was sound; the belief wasn't there.

In 2018, physician research found limited belief that MRD was clinically actionable — many community hematologists didn't know the term, and even MRD testers couldn't say how a result should change a decision. MRD faced the classic new-category trap: guidelines lagged, reimbursement lagged, and clinicians defaulted to the tests they knew. For a first-in-class diagnostic, the barrier wasn't proving the assay worked. It was making an entire field understand what MRD was, believe it mattered, and know what to do with it.

The strategy was behavioral, not promotional: educate, motivate, engage.

We built the unbranded education system — KnowMRD — that moved the field along an adoption continuum. A systems-mapping Knowledge Journey workshop charted the forces holding MRD back — status quo, cost fear, unclear guidelines — and the virtuous cycle that could replace them, then fixed a near star grounded in the Health Belief Model: clinicians understand MRD and believe its status matters, so that they act on it.

From that spine we produced a complete curriculum across the hematologic landscape — clinical data summaries, disease-state brochures spanning six malignancies, case-based studies, and bibliographies across nine disease areas — all unbranded, so the science, not the product, did the teaching.

The Outcome