Coeptis Therapeutics Files FDA 513(g) Submission for CD38 In Vitro Companion Diagnostic
513(g) request will help initiate dialogue with FDA and guide 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.
"With this 513(g) submission, we now look forward to initiating a dialogue with the FDA to advance the regulatory development of our CD38 diagnostics technology, which we believe has potential to significantly improve the treatment of severe and complicated oncology indications," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "For patients living with these very severe and difficult to treat conditions, this companion diagnostic could potentially relieve substantial burdens and cost of treatments to those individuals who likely won't respond to treatment. Importantly, predicting treatment could provide clinicians with the opportunity to choose a different, possibly more effective treatment plan, rather than losing time with an ineffective therapy as the disease progresses."
About Coeptis Therapeutics Holdings, Inc.
Coeptis Therapeutics Holdings, Inc., together with its subsidiaries including Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals, Inc., (collectively "Coeptis"), is a biopharmaceutical company developing innovative cell therapy platforms for cancer that have the potential to disrupt conventional treatment paradigms and improve patient outcomes. Coeptis' product portfolio and rights are highlighted by a universal, multi-antigen CAR T technology licensed from the University of
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Coeptis Therapeutics, Inc.
Andy Galy, Sr. VP of Communications
504-416-6965
andy.galy@coeptistx.com
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SOURCE Coeptis Therapeutics