Coeptis Therapeutics Holdings, Inc. announced that it has submitted a 513(g) request to the U.S. Food and Drug Administration (FDA) for an in vitro companion diagnostic test designed to be used with anti-CD38 monoclonal antibody therapies. The 513(g) request serves to introduce Coeptis' diagnostic technology to the FDA and to request guidance in determining the appropriate classification and regulatory pathway. The companion diagnostic test is intended to guide clinicians' decisions in difficult to treat oncology indications.

Treatments for complicated oncology indications that target CD38 can have significant impact on the immune system including increased risk for infectious complications, autoimmune disorders, and secondary malignancies, so in vitro companion diagnostics could be a valuable tool in guiding treatment decisions.