CareDx (CDNA) investor relations material

Strategic opportunities and market outlook

• Early-stage adoption in organ transplant molecular monitoring presents significant growth potential, with molecular testing becoming a standard of care and continued market penetration expected.

• The company is recognized as an innovator, with a 25-year mission focused on improving patient outcomes in transplantation.

• Solutions-based selling and a broad portfolio, including software, IVD kits, and molecular monitoring, drive adoption and operational efficiency at transplant centers.

• Digital solutions and SaaS transformation are key differentiators, supporting two-thirds of U.S. transplant centers and enhancing administrative efficiency.

• Ongoing investments in commercial teams and technology infrastructure aim to accelerate growth and market reach.

Operational performance and growth drivers

• Q2 saw strong test volume growth, with kidney testing up nearly 20% and 60 centers adopting surveillance protocols.

• Surveillance testing adoption is expanding, with over 200 kidney transplant programs in the U.S. and significant room for further protocol implementation.

• Epic system integration is expected to streamline operations, targeting 10% of volume by year-end and aiming for 50% by next year, despite administrative hurdles.

• Revenue cycle management overhaul has improved workflows, reduced zero pays, and is projected to increase ASP to $1,400 in the first half of 2025.

• Digital and patient solutions segment, about 15% of revenue, has grown at a 20–30% CAGR, with bundled solutions driving higher test utilization and revenue.

Policy, payer coverage, and clinical evidence

• Recent policy changes affirmed coverage for kidney surveillance testing, a major advocacy win, though draft LCDs propose frequency caps and single-test reimbursement per service date.

• The company submitted detailed feedback advocating for clinician-driven testing frequency and dual-test coverage for heart transplants.

• The KOR study demonstrated surveillance testing detects rejection up to three months earlier than clinical symptoms, supporting higher test frequency and payer adoption.

• Expansion of in-network commercial payer contracts, aided by new CPT codes, is expected to improve payment speed, predictability, and utilization.

• High clinical evidence publication rate supports medical necessity and drives broader payer acceptance.