FDA Rejects Venaxis 510(k) for APPY1 Blood Test

The FDA has determined that Venaxis’ APPY1 rapid blood test is not substantially equivalent to a predicate device and is therefore not eligible for 510(k) clearance, the company said Thursday. The test helps to identify children and young adults who are at low risk for appendicitis.

President and CEO Steve Lundy called the decision “very disappointing.” The company will review the FDA’s letter outlining the issues that led to the decision before determining next steps, he said.

Possible options include continuing to seek FDA clearance for APPYI, exploring study protocols, speeding up development of the APPY2 next-generation test or pursuing commercialization in Europe, where the test is CE-marked, Lundy said.

Venaxis believes the information and trial results provided to the FDA were compelling and will continue to work with the agency to get clearance for a blood-based appendicitis test, Lundy said. — Kellen Owings