Genetesis launches MICRO2 trial with announcement of first patient enrolment

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Genetesis, a leader in the field of magnetocardiography (MCG), announced the formal launch of the MICRO2 trial, marked by the enrollment of the trial's first patient at Ascension St. John Hospital in Detroit, Michigan, under Drs. Edouard Daher, MD, and Nishtha Sareen, MD, MPH, FACC, FSCAI.

MICRO2 (Magnetocardiography as a noninvasive diagnostic strategy for suspected myocardial ischemia with the absence of obstructive coronary artery disease) is a multicenter, prospective, observational study aimed at validating magnetocardiography’s ability to detect myocardial ischemia caused by underlying coronary microvascular dysfunction. The study will compare the diagnostic performance of MCG to a reference standard of invasively measured Coronary Flow Reserve (CFR). MICRO2 is expected to enroll at least 135 patients and will be conducted with the support of at least six enrolling sites – Ascension St. John Hospital, Cleveland Clinic, Hackensack Meridian Mountainside Medical Center, Saint Luke’s Health System Kansas City, The Christ Hospital, and University of Florida – and is funded by Genetesis, Inc.

The application of CardioFlux MCG for diagnosis may represent a significant opportunity to reduce the cost and burden typically associated with a diagnosis without compromising on diagnostic accuracy, and if validated by MICRO2, making diagnosis more accessible.

MICRO2 trial enrollment is expected to close by the end of 2024, with results reported in Q1 of 2025. Positive results would be followed by a De Novo request for market authorization to FDA shortly thereafter, and if successful, would represent the first diagnostic to be FDA approved for this application.