Guardant Health said its colorectal cancer screening business Shield is scaling quickly while its companion diagnostic franchise is gaining reimbursement and clinical traction. At Morgan Stanley's 24th Annual Global Healthcare Conference, co-CEO AmirAli Talasaz and CFO Mike Bell said second-quarter total revenue growth exceeded 40%, with last-twelve-month revenue growth of 42.74%. Oncology volume growth surpassed 60%, and Shield growth exceeded 250% year over year.
The company remains unprofitable, with earnings per share of -$3.50, but reported a gross profit margin of 65%. Guardant said its biopharma business is on track for approximately $300 million in revenue by 2028, implying 10% to 15% annual growth. It estimated tissue biopsy penetration at 70% to 80%, liquid biopsy penetration at about 40%, and combined liquid and tissue testing at 1.2 to 1.3 tests per patient.
For Guardant360 Liquid CDx, the current Medicare reimbursement rate is $5,000, while the overall average selling price is about $3,000. The company expects Advanced Diagnostic Laboratory Test status in the first half of 2025, with an expected Medicare rate of $8,455. It targets an overall ASP of about $5,000 by 2028, representing roughly 60% realization of the ADLT rate across payer types over an 18- to 24-month transition.
Shield's ASP has recently been in the $770 to $800 range, and Guardant guided to about $770 for the remainder of 2024. The Medicare ADLT rate for Shield is $1,495 and has been in place for two years. Cost per test was just over $400 in the second quarter, with Guardant expecting about $350 by year-end and a long-term target of $200. A new FDA-approved workflow is expected to cut costs by about 15% by year-end, and further automation is expected to drive a larger reduction in late 2027.
Commercially, Shield reaches 80% of eligible patients, or 94 million people, with coverage wins from Carelon and EviCore. Guardant expanded its sales force from 300 representatives at the start of the year to more than 400 by the second quarter and plans to scale toward 600 to 700 representatives. The company said Shield is supported by more than 200,000 physician testing experiences and multiple randomized studies, and it has contracts with tens of thousands of phlebotomists nationwide.
In companion diagnostics, Guardant360 Liquid CDx, a 700-plus gene panel, was approved as the sole companion diagnostic for camizestrant in longitudinal breast cancer monitoring. The panel is about 10 times larger than the prior panel and includes epigenomic data. Guardant estimated the camizestrant opportunity at about 37,000 eligible breast cancer patients, which could translate to about 150,000 annual tests if monitoring is quarterly. Payment changes through a CMS National Coverage Determination, NCD 90.2, are expected to take about a year.
The company also said Reveal Ultra, a tumor-informed minimal residual disease product designed to complement Reveal, is expected to launch by the end of 2024, pending final internal validation.
