VCYT: Ready, Set, Prosigna – US Launch Goes Live

Research evidence excerpt

VCYT: Ready, Set, Prosigna – US Launch Goes Live

June 8, 2026

State of the union on this testing market today? Oncotype DX is deeply embedded in the NCCN guidelines and

clinical practice. In 2025 Exact talked about roughly 80% penetration in the US, meaning test volumes are growing

with breast cancer incidence growth. Point? The commercial task for Prosigna is share take. Size of testing opportunity?

Approximately 225,000 HR+/HER2- breast cancer patients are diagnosed each year in the US. VCYT segments

this population into 100,000 post-menopausal/node-negative, 50,000 post-menopausal/node-positive, 50,000 pre-

menopausal/node-negative, and 25,000 pre-menopausal/node-positive. The OPTIMA data suggests Prosigna may have

a compelling case in the 75,000 pre-menopausal patients and the ~20,000 patients with >3 nodes.

What might this mean for numbers? On pricing, VCYT’s intention is to “crosswalk” Prosigna to the Afirma

reimbursement code. Low end of pricing possibility described as $2,500, the historical payment for the IVD version,

making for a potential range of $2,500-$3,300. We take the midpoint and call it $2,900. With that pricing input, every

5 points of share gain/penetration within this addressable patient population = $33M in revenue.

What is still on the to do list for Prosigna? 1) Secure MolDX coverage. Prosigna has some commercial coverage but

is not yet supported by Medicare. MolDX reimbursement decisions can be opaque and lengthy but VCYT has submitted

the technical assessment and believes decision to “pan out imminently.” 2) Inclusion in NCCN guidelines. Oncotype DX

is specifically named in guidelines – Prosigna will need that, too.

So how do we think this goes? There is undoubtedly wood to chop here. Breast cancer represents a new commercial