Veracyte (VCYT) Study update summary

OPTIMA trial results and clinical impact

• OPTIMA phase III trial showed Prosigna-guided treatment allows over two-thirds of high-risk, node-positive, ER-positive, HER2-negative early breast cancer patients to safely avoid chemotherapy without compromising outcomes or increasing recurrence risk.

• The trial included more than 4,400 patients aged ≥40, with robust results across subgroups, including premenopausal women and those with up to nine positive nodes.

• Prosigna demonstrated superior prognostic accuracy, identifying patients misclassified as low risk by other tests who were actually high risk.

• The study mandated ovarian function suppression for all premenopausal women, providing definitive predictive data for this group.

• OPTIMA provides Level 1A prospective evidence that molecular biology, not clinical factors alone, should guide chemotherapy decisions, especially for premenopausal women and those with extensive nodal involvement.

OPTIMA trial methodology and results

• Patients were randomized based on Prosigna risk scores, with the primary endpoint being invasive breast cancer free survival (IBCFS) and a non-inferiority margin of 3%.

• Five-year IBCFS was 91.8% in the control arm and 90.3% in the test-directed arm, demonstrating non-inferiority.

• Subgroup analyses showed consistent results across menopausal status, tumor grade, size, nodal status, and intended chemotherapy.

Prosigna’s clinical and commercial positioning

• Prosigna is the only commercial test built on the PAM50 genomic classifier, validated to predict chemotherapy benefit regardless of menopausal status or nodal involvement, and up to 9 positive nodes.

• The test achieved non-inferior five-year cancer-free survival rates compared to standard chemotherapy, supporting safe de-escalation of treatment.

• Prosigna’s robust evidence base positions it as the new standard of care for early-stage hormone-receptor-positive breast cancer.

• The company is launching Prosigna as a laboratory-developed test (LDT) in its CLIA lab, with workflow integration and digital ordering platforms ready for adoption, and commercial launch set for June 8, 2026.

• Commercial strategy focuses on key opinion leaders and guideline inclusion, with reimbursement supported by existing commercial contracts and anticipated Medicare coverage.