Micoy Therapeutics Achieves FDA Breakthrough Designation for Revolutionary Point-of-Care Test Targeting Folate Deficiency

In a significant regulatory milestone that could transform diagnostic testing for a critical nutritional deficiency, Brooklyn-based Micoy Therapeutics announced on January 12, 2026, that the FDA has granted Breakthrough Device Designation to its NeuroLume™ Test. This innovative point-of-care diagnostic represents the first FDA-recognized test specifically designed to detect folate receptor alpha autoantibodies (FRAAs), addressing a previously unmet medical need that affects millions of patients worldwide.

The FDA's Breakthrough Device Designation recognizes the NeuroLume Test's potential to provide more effective diagnosis of folate deficiency associated with autoantibodies that impair folate transport. This regulatory recognition validates a sophisticated understanding of folate metabolism that goes beyond traditional serum folate measurements, offering clinicians mechanistic insights that could fundamentally change how folate deficiency is diagnosed and managed.

Addressing a Hidden Cause of Folate Deficiency

Folate deficiency has long been recognized as a critical health concern, particularly during pregnancy and early development. However, traditional diagnostic approaches have focused primarily on measuring systemic folate levels, potentially missing cases where folate transport is impaired by autoantibodies targeting folate receptor alpha. These autoantibodies can disrupt cellular folate uptake even when serum folate levels appear normal, creating a diagnostic blind spot that may affect patient outcomes.

The NeuroLume Test addresses this gap by detecting autoantibodies that bind to folate receptor alpha, the primary mechanism by which cells take up folate from the bloodstream. When these autoantibodies are present, they can block folate transport across cell membranes, leading to functional folate deficiency despite adequate dietary intake or supplementation. This mechanism has been implicated in various clinical scenarios, including unexplained infertility, developmental concerns, and treatment-resistant folate deficiency.

Dr. Prem Premsrirut, CEO of Micoy Therapeutics, emphasized the clinical significance of this regulatory milestone: "Receiving FDA Breakthrough Device Designation represents an important milestone in the development of the NeuroLume Test. This designation reflects the FDA's recognition of the potential clinical importance of detecting folate receptor autoantibodies at the point of care."

Revolutionary Point-of-Care Technology

What sets the NeuroLume Test apart from existing diagnostic approaches is its design as a single-use, qualitative immunoassay that can be performed at the point of care using either fingerstick or venipuncture whole blood specimens. This accessibility could dramatically expand testing capabilities, allowing healthcare providers to obtain results immediately rather than waiting for laboratory processing.

The test's proposed clinical applications span both adult and pediatric populations, reflecting the broad impact of folate receptor autoantibodies across age groups. In adults, the test is intended to support clinical assessment in patients undergoing evaluation for possible folate deficiency, including pregnant patients, individuals with unexplained infertility, and those with treatment-resistant folate deficiency or macrocytic anemia.

For pediatric patients, the NeuroLume Test could prove particularly valuable in evaluating children with family histories of cerebral folate deficiency or unexplained developmental concerns where impaired folate transport is suspected. Early identification of folate receptor autoantibodies in children could enable targeted interventions that might prevent or mitigate developmental complications.

Scientific Foundation and Clinical Validation

The development of the NeuroLume Test builds upon decades of foundational research by Dr. Edward V. Quadros, whose work established folate receptor autoantibodies as biologically meaningful immune markers implicated in disrupted folate transport. This scientific foundation provides credibility to Micoy's diagnostic approach and suggests potential applications beyond the initial indications.

The FDA's Breakthrough Device Designation provides Micoy with enhanced regulatory support as the company advances through analytical validation and clinical studies. This designation facilitates more frequent communication with FDA reviewers and potentially expedited review processes, which could accelerate the path to market clearance.

Market Implications and Regulatory Pathway

The diagnostic testing market for nutritional deficiencies represents a substantial opportunity, particularly as healthcare systems increasingly embrace precision medicine approaches. The NeuroLume Test's ability to identify a specific mechanism of folate deficiency could enable more targeted treatment strategies, potentially improving outcomes while reducing healthcare costs associated with ineffective supplementation.

Importantly, the FDA has clarified that results from the NeuroLume Test are intended to aid in identifying folate deficiency associated with autoantibodies and must be interpreted in conjunction with other clinical and laboratory findings. The test is not intended to diagnose reproductive, developmental, or neurological disorders directly, but rather to provide mechanistic information that supports clinical decision-making.

Broader Implications for Precision Diagnostics

Micoy's success in obtaining Breakthrough Device Designation reflects broader trends toward mechanistic diagnostics that provide insights into disease pathophysiology rather than simply measuring biomarker levels. This approach aligns with precision medicine principles, where understanding the underlying biological mechanisms enables more targeted and effective interventions.

The company's focus on pathogenic autoantibodies as diagnostic targets suggests potential applications beyond folate metabolism. As Micoy continues to develop its platform technology, the success of the NeuroLume Test could validate approaches to detecting other autoantibodies that interfere with normal physiological processes.

For patients and healthcare providers, the NeuroLume Test represents hope for better understanding and management of folate deficiency, particularly in cases where traditional approaches have proven inadequate. As Micoy advances through clinical validation studies and regulatory submissions, this innovative diagnostic could establish new standards for evaluating nutritional deficiencies and autoimmune mechanisms that affect essential metabolic processes.