FDA Breakthrough designation supports development of a point-of-care test for detecting folate receptor autoantibodies
NEW YORK, NY, UNITED STATES, January 12, 2026 /EINPresswire.com/ — Micoy Therapeutics today announced that the NeuroLume™ Test has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH). The designation recognizes the NeuroLume Test’s potential to address a significant unmet medical need by enabling point-of-care detection of folate receptor alpha (FRα) autoantibodies, also known as folate receptor autoantibodies (FRAAs).
The NeuroLume Test is a single-use, qualitative immunoassay intended for the detection of autoantibodies to human folate receptor alpha in fingerstick or venipuncture whole blood specimens. The test is designed for point-of-care use as an aid in the assessment of folate deficiency associated with the presence of FRAAs.
Under the proposed indication evaluated by the FDA, the NeuroLume Test is intended to support clinical assessment in:
• Adults undergoing evaluation for possible folate deficiency, including pregnant patients, infertile patients, individuals with unexplained folate deficiency or macrocytic anemia, or clinical scenarios where impaired folate transport due to FRAAs is being considered.
• Pediatric patients undergoing evaluation for possible FRAA-associated folate deficiency, including those with a family history of cerebral folate deficiency or unexplained developmental concerns where impaired folate transport is part of the clinical differential.
The FDA’s Breakthrough Device Program is intended to facilitate the development and review of medical devices that have the potential to provide more effective diagnosis or treatment of serious or irreversibly debilitating conditions and that address an unmet medical need.
“Receiving FDA Breakthrough Device Designation represents an important milestone in the development of the NeuroLume Test,” said Prem Premsrirut, MD, PhD, Chief Executive Officer of Micoy Therapeutics. “This designation reflects the FDA’s recognition of the potential clinical importance of detecting folate receptor autoantibodies at the point of care, while we continue to advance the necessary analytical and clinical validation studies.”
As outlined by the FDA, results from the NeuroLume Test are intended to aid in identifying folate deficiency associated with FRAAs and must be interpreted in conjunction with other clinical and laboratory findings. The test is not intended to diagnose reproductive, developmental, or neurological disorders. Breakthrough Device Designation does not constitute FDA clearance, approval, or authorization, nor does it guarantee that a future marketing submission will be granted.
Micoy plans to engage with the FDA through the Breakthrough Device Program as development continues, including analytical validation and clinical studies to support future regulatory submissions.
Micoy acknowledges the foundational scientific contributions of Dr. Edward V. Quadros (Brooklyn, NY), whose decades of research established FRAAs as a biologically meaningful immune marker implicated in disrupted folate transport across multiple clinical contexts, including maternal and neurodevelopmental settings.
About the NeuroLume™ Test
The NeuroLume™ Test is an investigational point-of-care immunoassay under development to detect folate receptor alpha autoantibodies that may impair folate transport. The test is designed to provide mechanistic information not captured by standard systemic folate measurements.
About Micoy Therapeutics
Micoy Therapeutics is a biotechnology company developing diagnostic and therapeutic solutions targeting pathogenic autoantibodies, with a focus on immune-mediated mechanisms of disease.
Micoy is headquartered in Brooklyn, NY. Visit www.micoytherapeutics.com.
Media Contact:
Micoy Therapeutics, Inc.
press@micoytx.com
760 Parkside Ave., Suite 206
Brooklyn, NY 11226
Shilpa Parikh
Micoy Therapeutics
+1 215-850-5366
shilpa.parikh@micoytx.com
Legal Disclaimer:
EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability
for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
