Company: CSTL
Filing Date: 2025-08-04
Form Type: 10-Q
Source: 0001447362-25-000097
Chunk: 38

Company: CASTLE BIOSCIENCES INC
Filing Date: 2025-08-04
Form: 10-Q
Item: Item 1
Chunk 38
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 offered as LDTs (that were first marketed before May 6, 2024) that are approved by New York State Department of Health (“NYSDOH”). Our proprietary tests, outlined above, are all NYSDOH approved. We believe this final ruling will have no material impact on our existing test offerings given all of our tests were marketed before May 6, 2024. In addition, on March 31, 2025, the United States District Court for the Eastern District of Texas vacated the FDA’s LDT final rule. The U.S. government did not appeal the ruling, and the deadline to do so has passed; therefore, the court’s decision stands.

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.

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 For the six months ended June 30, 202518,602 9,137 2,092 29,831 938 16,602 3,605 50,976 Q1 20248,384 3,577 998 12,959 422 3,429 4,078 20,888 Q2 202