We're pleased to share that Voyant has successfully completed its first clinical trial with Northwestern University Feinberg School of Medicine. The study evaluated the feasibility of using a fully automated point-of-care urine diagnostic platform to accurately determine the pregnancy status of patients.
The study's objective was to demonstrate a device accuracy of at least 95%. Voyant's device exceeded this accuracy, achieving a final accuracy of 98.15% on 54 blinded patient samples, representing a 95% confidence level.
The results included no false positives, demonstrating that the device was able to prevent cross-contamination of results from different patients. The singular false negative from the study surfaced an opportunity to improve our algorithm. An updated algorithm was able to achieve 100% accuracy on the same 54 sample images captured by the device.
This study was performed in collaboration with Principal Investigator and Associate Professor Dr. MaryEllen Pavone and researcher Rafael Confino from Northwestern’s Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility. We also worked with researcher Megan Connolly from the Woodruff Lab. We are very grateful for their partnership and are excited to welcome Dr. Pavone to our Medical Advisory Board. We look forward to our continued collaboration in the future.
In addition, we'd like to thank Teresa Woodruff, as well as Voyant Advisory Board members Bob Shaw, Eric Shain and David Grenache, for their generous support on this study.
For more information, please reach out to Claire Zhou at firstname.lastname@example.org.