In addition to seeking guidance on the P2V diagnostic test, the pre- investigational device exemption (IDE) application will also include an investigational plan overview for the tumor grading potential of the test.
In addition to its diagnostic potential, the test’s protein biomarkers were able to distinguish aggressive prostate cancer (cancers with a Gleason grade of seven or higher) from non-aggressive prostate cancer with a sensitivity and specificity of 92% and 55% respectively. Once the FDA provides its response to the pre-IDE application, the company will formalize plans for its clinical study.
A submission made under the pre-IDE process is not an official IDE application as described in 21 CFR Part 812. The pre-IDE process is designed to help companies obtain early, informal input on aspects of a future IDE application and offers assistance in establishing the parameters for official IDE applications when unique diagnostic tests involving innovative technologies are being pursued.
Christopher Moreau, president and CEO of Miraculins, said: “We are confident in the results of our research that demonstrates the potential of P2V to eliminate one out of every four unnecessary biopsies worldwide, which is a potential $500 million market.”