Equity research Immunovia: New study and FDA choose not to appeal LDT ruling

Earlier today, on June 4, Immunovia announced the initiation of a new study with PancreaSure in a group at unusually high risk for pancreatic cancer, together with Leiden University. Furthermore, around two months ago, a federal judge in Texas ruled against the FDA regarding laboratory-developed tests (LDTs). This weekend, the deadline passed for the FDA to appeal the decision, solidifying the ruling.

New study with Leiden University

Immunovia is to carry out a case-controlled study to evaluate the accuracy of the Immunovia test in detecting early-stage pancreatic cancer. The blood samples will be collected from approximately 150 CDKN2A patients in Leiden. This mutation is associated with a highly elevated risk of developing pancreatic cancer. The Leiden University Medical Center (LUMC) works with over 300 patients annually, offering pancreatic cancer surveillance and research. The blood samples used in the study have been collected over several years. If the study demonstrates solid accuracy, the expanded clinical evidence behind PancreaSure should be helpful later when it comes to securing reimbursement for the test. Although the timeline for the study was not communicated, Immunovia reiterates the plan for commercial launch of the PancreaSure test in September of 2025.

FDA chooses not to appeal ruling by Texas judge regarding LDT overview

As we mentioned earlier in our Mrkt BUZZ in April, a federal judge ruled against the FDA regarding LDTs. Specifically, the US district court for the Eastern District of Texas determined that the FDA’s final rule was an overstep of authority. Since then, the FDA has had a 60-day window to appeal the ruling, which expired over the weekend. The choice not to appeal solidifies the status of LDTs as different from medical devices and IVDs. A democratic president in the future might still try to revive the legislation, but for now, with the Trump administration in place, the issue appears settled.

Taken together, , both news items are positive for Immunovia. We believe it is natural to study PancreaSure in smaller high-risk mutation populations to help build evidence of clinical utility. It would have been interesting to learn more about the study with Leiden, but it is possible that more information will be released as the study progresses. As for the ruling in the USA, we still believe Immunovia will pursue FDA approval for reimbursement reasons. However, the new regulatory landscape could provide more flexibility in addressing the US market if needed.

Read our latest research update here.

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