Pacific Edge Releases Medicare LCD Evidence Rebuttal

Pacific Edge has today released a detailed rebuttal of the evidentiary review used to support the finalization of the ‘Genetic Testing in Oncology: Specific Tests’ (L39365¹) Local Coverage Determination (LCD) that is expected to come into effect on 24 April 2025.

Pacific Edge considers substantial parts of the evidentiary review underpinning the LCD to misinterpret or misunderstand Cxbladder evidence. Pacific Edge is particularly disappointed with the review, because it questions our steadfast commitment to generating the compelling clinical evidence required to drive behavior change in physicians. It has released the review because it is determined that the view put forward in the LCD should not go publicly unchallenged.

Our review finds:

1. Novitas conflates feasibility testing of biomarkers in urine with test development of a specific clinical diagnostic lab test.
2. Novitas misinterprets evidence for Cxbladder (Triage and Detect) by framing them as screening tests for an asymptomatic population, rather than tests to support clinical decision making.
3. Novitas misinterprets evidence for Cxbladder Detect and Triage because it misunderstands the patient population targeted by the tests (patients presenting with hematuria).
4. Novitas misinterprets evidence for Cxbladder because it does not understand how the information generated by the tests is used to guide clinical decision making.
5. Novitas has based its evidentiary review on a preliminary version of the Cxbladder test, referred to as uRNA-D, which is not the test offered to Medicare patients. Feasibility testing to prove that biomarkers from tissue can be detected in urine from a predecessor product is not appropriate for a coverage or non-coverage determination.

Pacific Edge Chief Executive Dr Peter Meintjes said: “Pacific Edge’s clinical evidence program is focused on developing high-quality clinical evidence for Cxbladder tests in a structured framework. Specifically, we seek to produce evidence that is founded on the frameworks of Analytical Validity, Clinical Validity, and Clinical Utility, with the endpoints and sample sizes required for coverage decisions and guideline inclusion.

“Our goal in producing this rebuttal is to ensure all our stakeholders – patients, clinicians, medical policy makers, healthcare payers, and our investors and our own people – fully understand our position and the justification for our confidence in the clinical value of Cxbladder.”

Pacific Edge’s evidentiary review can be accessed here.

The ‘Genetic Testing in Oncology: Specific Tests’ (L39365) LCD and the associated Local Coverage Article ‘Response to Comments: Genetic Testing in Oncology: Specific Tests’ (A59856) can be accessed using this link.

¹ L39365 was proposed and finalized by Novitas, the Medicare Administrative Contractor (MAC) with jurisdiction for Pacific Edge’s laboratory in Hershey, Pennsylvania.