Venaxis, a US-based in vitro diagnostic firm, has completed the patient enrollment in its pivotal clinical study of the APPY1 test in the US.
The APPY1 test, a unique appendicitis test, has projected high sensitivity and negative predictive value and is being developed to aid in the identification of patients at low risk for acute appendicitis, allowing for more conservative patient management.
The company expects to announce top-line data following the required patient follow-up period and subsequent database lock and required analysis of the data.
The study enrolled patients at approximately 27 hospital sites across the US, and the pivotal data will be based on approximately 2,000 net evaluable patients.
Venaxis president and CEO Steve Lundy said completing this significant pivotal US study is a major milestone for Venaxis and company looks forward to reporting the data when it is available.
"We will work to finalize our 510(k) and final data package for FDA submission at or near the end of the first quarter, assuming positive data," Lundy added.
"In the meantime, we remain committed to our diligent market development efforts and expect to be well positioned to launch the APPY1 Test in the United States upon receipt of clearance."