Company: CSTL
Filing Date: 2025-11-03
Form Type: 10-Q
Source: 0001628280-25-048254
Chunk: 189

Company: CASTLE BIOSCIENCES INC
Filing Date: 2025-11-03
Form: 10-Q
Item: Item 2
Chunk 189
---
 to LDTs will have no material impact on our existing test offerings.

In July 2025, the FDA granted Breakthrough Device designation to our DecisionDx-Melanoma test. We believe this designation highlights the test’s potential to improve melanoma care through individualized prognostic insights. The Breakthrough Device designation is intended to expedite the development and review of certain medical devices that may offer more effective diagnosis or treatment of life-threatening conditions.

Delivered Test Reports

The number of test reports we deliver is a key indicator that we use to assess our business. A test report is generated when we receive a sample in our laboratory, and then the relevant test information is entered into our Laboratory Information Management System, the laboratory portion of the test is performed, including proprietary algorithmic analysis of the combined biomarkers, and a report is then delivered to the clinician who ordered the test.

30

The number of test reports delivered by us are presented in the table below:

Proprietary Dermatologic GEP Tests DecisionDx-MelanomaDecisionDx-SCCDiagnostic GEP offeringDermatologic TotalDecisionDx-UMTissueCypherIDgenetix(1)Grand TotalQ1 20258,621 4,375 926 13,922 470 7,432 2,578 24,402 Q2 20259,981 4,762 1,166 15,909 468 9,170 1,027 26,574 Q3 202510,459 4,186 1,151 15,796 436 10,609 — 26,841 For the nine months ended September 30, 202529,061 13,323 3,243 45,627 1,374 27,211 3,605 77,817 Q1 20248,384 3,577 998 12,959 422 3,429 4,078 20,888 Q2 20249,585 4,277 1,099 14,961 456 4,782 4,903 25,102 Q3 20249,367 4,195 933 14,495 397 6,073 5,045 26,010 For the nine months ended September 30, 202427,336 12,049 3,030 42,415