Detailed Narrative
Prosigna Launch and OPTIMA Trial Impact
Veracyte successfully launched Prosigna LDT in the U.S. following the presentation of practice-changing OPTIMA trial results at ASCO. The OPTIMA trial, an independent prospective Phase III study, demonstrated that over two-thirds of clinically high-risk early-stage breast cancer patients, including premenopausal women and those with up to 9 positive lymph nodes, may safely avoid chemotherapy. This Level 1A evidence significantly expands Prosigna's clinical utility beyond node-negative patients. The company is seeing tremendous physician enthusiasm and is expanding its sales force to meet demand, with over 100 institutions evaluating broad adoption. Discussions with MolDX for Medicare coverage are ongoing, with an expected price around $2,500.
TrueMRD Platform and Bladder Cancer Entry
Veracyte entered the rapidly growing MRD market with the launch of TrueMRD for muscle invasive bladder cancer (MIBC) recurrence monitoring. This test is the first commercial application of its TrueMRD platform, which utilizes whole genome sequencing for both landmark and subsequent liquid biopsy surveillance tests, offering a broader view of tumor biology and tracking tumor evolution. The company secured Medicare reimbursement for this initial indication and plans to leverage its Decipher Bladder brand and relationships in urology to accelerate adoption. The TrueMRD platform is designed to be extensible to multiple tumor types and clinical applications over time⏳, positioning it as a long-term growth driver.
Decipher Prostate Performance and Evidence Generation
Decipher Prostate delivered a strong quarter with 20% year-over-year revenue growth and 17% volume growth, totaling nearly 30,000 tests. This growth was driven by increased ordering positions and deeper penetration among existing physicians, particularly in intermediate and high-risk localized disease, post-prostatectomy, and biochemical recurrence. While low-risk volume guidance was slightly reduced due to NCCN guideline changes, the company is investing in new evidence generation, with initial readouts expected as early as 2027, to support broader adoption in this segment. Decipher Prostate was featured in over 35 publications and abstracts, including Level 1b evidence from the EZAMET trial, further solidifying its clinical utility.
Afirma Growth and Operational Improvements
Afirma continued its strong performance with 18% year-over-year revenue growth and 10% volume growth, totaling approximately 18,600 tests. This was driven by increased utilization, expansion of the ordering physician base, and ongoing market share gains. Revenue also benefited from sustained ASP gains and favorable commercial payer reimbursement. Operational efficiencies from the B2 transcriptome workflow significantly improved the no-result rate, contributing approximately 400 basis points to volume growth. Evidence generation remains robust, with Afirma featured in 10 conference abstracts and multiple peer-reviewed manuscripts, and growing academic and industry collaborations through Afirma Grid.
Strategic Investments and Capital Deployment
Veracyte generated $45.8 million in cash from operations, ending the quarter with $485.2 million in cash, cash equivalents, and short-term investments. The company is maintaining its full-year adjusted EBITDA guidance of greater than 26%, reflecting strategic investments in its growth initiatives, including the expansion of the Prosigna sales force and R&D for pipeline development. Management prioritizes investing in the business for continued growth, evaluating M&A opportunities for the right assets, and regularly discusses returning capital to investors, though current focus remains on internal opportunities.