Company: CSTL
Filing Date: 2025-05-05
Form Type: 10-Q
Source: 0001447362-25-000069
Chunk: 33

Company: CASTLE BIOSCIENCES INC
Filing Date: 2025-05-05
Form: 10-Q
Item: Item 1
Chunk 33
---
 discontinued effective May 2025.

Government Regulation and Oversight of Laboratory Developed Tests

On May 6, 2024, the U.S. Food and Drug Administration (“FDA”) published a final rule on the regulation of LDTs which amends the FDA's regulations to make explicit that LDT's are devices under the FD&C Act. The FDA issued a policy to phaseout, over the course of four years, its general enforcement discretion approach to LDTs and also issued targeted enforcement discretion policies for certain categories of LDTs. The FDA is continuing enforcement discretion for currently marketed tests offered as LDTs (that were first marketed before May 6, 2024) that are approved by 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. It is unclear whether the court’s ruling will be appealed.

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-UMTissueCypherIDgenetixGrand TotalQ1 20258,621 4,375 926 13,922 470 7,432 2,578 24,402 Q1 20248,384 3,577 99812,959 422 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