RAPID FRAA DIAGNOSTIC
The first rapid test for folate autoantibodies
NeuroLume™ is developing a 10-minute point-of care test for folate receptor autoantibodies, designed for fertility clinics, OB-GYN offices, and pediatric practices
Received FDA Breakthrough Device Designation: Q253172
T
C
RAPID LATERAL FLOW TEST
FRAA Positive Detected
10
MINUTES TO RESULT
1 in 36
CHILDREN WITH ASD (US)
$2.5B+
INFERTILITY DIAGNOSTICS MARKET
0
FDA-CLEARED FRAA TESTS
>1M units
MONTHLY PRODUCTION CAPACITY
FIRST-MOVER ADVANTAGE
LATERAL FLOW PLATFORM
MATERNAL HEALTH & FERTILITY
AUTISM RISK DETECTION
BREAKTHROUGH DEVICE PATHWAY
FOLINIC ACID INTERVENTION
>1M UNITS/MONTH MANUFACTURING CAPACITY
Hidden antibodies.
Devastating outcomes.
No rapid test.
THE PROBLEM
Folate receptor autoantibodies, or FRAAs, can block the transport of folate to the developing fetus and brain. Standard prenatal bloodwork will not find them. Standard folate supplements will not fix them. This happens even when a patient's serum folate levels appear completely normal.
CONDITIONS LINKED TO FRAAS
Miscarriage & Recurrent Pregnancy Loss
Neural Tube Defects
Autism Spectrum Disorder (ASD)
Unexplained Infertility
Cerebral Folate Deficiency
Rett Syndrome & Movement Disorders
Treatment-Resistant Depression
Developmental Regression
Solving a diagnostic gap
OPPORTUNITY
The core opportunity is not educating the market that blood-based screening exists. It is adding a missing immunological layer to channels that already order maternal, fertility, and neurodevelopmental tests
CLEAR UNMET NEED
FRAAs can disrupt folate transport even when standard serum folate appears normal, leaving clinicians without a rapid way to identify a potentially actionable mechanism.
POINT OF CARE FORMAT
The platform adapts ELISA-based FRAA detection into a lateral flow test intended to return a qualitative result in 10 minutes from a blood sample.
INFRASTRUCTURE ADVANTAGE
A collaboration between Micoy's folate receptor science with Beacon Scientific’s rapid diagnostics manufacturing and distribution backbone
THE TEST
ELISA precision.
10-minute results.
Point-of-care scale.
NeuroLume is designed to move FRAA screening closer to the clinical moment, where decisions are made and follow-up can happen sooner
01
RAPID RESULT
Designed to deliver a qualitative FRAA result in approximately 10 minutes without centralized lab turnaround
02
TWO-ANTIBODY MECHANISM
Intended to detect blocking and binding autoantibody subtypes, both relevant to impaired folate receptor function.
03
ACTIONABLE PATHWAY
A positive result may support folinic acid intervention, enhanced prenatal monitoring, or targeted neurodevelopmental evaluation.
WHO IT'S FOR
Designed for the
Clinicians who need it most
NeuroLume is positioned for clinical channels where testing behavior, urgency, and a plausible intervention pathway already overlap
Fertility Specialists & REIs
For unexplained infertility, recurrent implantation failure, and pregnancy loss cases where standard workups do not provide an answer.
Pediatric Neurologists & Developmental Pediatricians
For autism, developmental regression, or cerebral folate deficiency cases where biology may guide intervention.
OB-GYNs & Maternal-Fetal Medicine
For pre-conception and first-trimester screening when folate transport has high clinical relevance.
Functional Medicine
For clinicians already focused on immunology, nutrition, and folate metabolism, with a need for more precise testing.
OUR SCIENCE
It's not about
how much folate.
It's about how much.
Gets through.
Folate — Vitamin B9 — is essential for cell division, DNA synthesis, and fetal neural development. For decades, public health campaigns have focused on dietary folate intake and folic acid supplementation. But in FRAA-positive patients, the problem is not deficiency in the diet. It is a failure of delivery.
Folate receptor alpha (FRα) is the primary transporter responsible for moving folate across the blood-brain barrier and the placental barrier. When the immune system produces antibodies that block or bind to FRα, these critical transport mechanisms are impaired — regardless of how much folate is consumed or supplemented.
FRAA TYPES DETECTED
Blocking Antibodies (IgG & IgM)
Physically obstruct folate from binding to the receptor, preventing CNS and placental uptake entirely. Associated with the most severe clinical presentations.
Binding Antibodies (IgG & IgM)
Adhere to the receptor and trigger immune-mediated downregulation of transport function. Can coexist with blocking antibodies and are independently associated with adverse outcomes.
Standard folic acid supplementation does not correct FRAA-mediated transport failure. Folinic acid — a reduced, receptor-independent form of folate — can bypass blocked receptors and restore delivery. But folinic acid therapy is only indicated once FRAAs are identified. That is what NeuroLume makes possible.
PEER-REVIEWED EVIDENCE
Built on Dr. Edward Quadros’ FRAA research
NeuroLume's platform is built on the foundational research of Dr. Edward Quadros, who first discovered and characterized folate receptor autoantibodies. His decades of work establishing the clinical significance of FRAAs form the scientific bedrock of every test NeuroLume produces.
These studies collectively demonstrate that folate receptor autoantibodies are a clinically significant, measurable, and treatable biological barrier — and that folinic acid intervention produces documented neurological improvement in FRAA-positive patients. NeuroLume™ makes detection possible at the point of care."
DR. EDWARD QUADROS · SCIENTIFIC FOUNDER, NEUROLUME™
ROADMAP
Clear milestones.
Disciplined execution.
A clear development path from prototype completion through validation, FDA submission, first revenue, and national scale-up
2025–26
FOUNDATION
FDA Breakthrough Device Designation
Prototype completion
Analytical validation
2027
FDA & PAYERS
Multi-site clinical validation
FDA de novo submission
Payer & reimbursement groundwork
Early 2028
FIRST REVENUE
Fertility clinics & autism centers launch
LDT revenue generation
Real-world clinical data collection
2028-29
SCALE & LICENSE
US national scale-up
US licensing agreements
Global partnership expansion
LEADERSHIP
The partnership behind Neurolume.
Micoy Therapeutics and Beacon Scientific formed NeuroLume to do what neither could accomplish alone — combine world-class folate receptor science with the manufacturing, regulatory, and commercial infrastructure to bring a validated rapid test to market at national scale.
FOLATE RECEPTOR SCIENCE
Micoy Therapeutics was founded on the conviction that folate receptor autoantibodies represent one of the most significant and underaddressed biological mechanisms in maternal and child health. Built around the foundational research of Dr. Edward Quadros, Micoy provides the scientific credibility, clinical strategy, and regulatory vision that drives the NeuroLume program.
FOLATE BIOLOGY
NEURODEVELOPMENT
CLINICAL STRATEGY
REGULATORY AFFAIRS
MANUFACTURING & DISTRIBUTION
Beacon Scientific brings the operational backbone to transform a validated assay into a nationally deployed diagnostic product. With expertise in lateral flow platform technology, scalable manufacturing, and diagnostics commercialization, Beacon ensures NeuroLume can move from prototype to market — and from market to scale — with speed and precision.
MANUFACTURING
DISTRIBUTION
SCALE-UP
A team that has
done this before.
CEO, MICOY THERAPEUTICS
Prem Premsrirut
Diagnostics commercialization, clinical strategy, and collaboration leadership
Andre Alfaro
CEO, BEACON SCIENTIFIC
Rapid diagnostics manufacturing, distribution operations, and scale-up infrastructure
Dr. Edward Quadros
Discoverer of folate receptor autoantibodies and authority on FRAA biology
FOUNDER & SCIENTIFIC DIRECTOR
Shilpa Patel
CHIEF BUSINESS OFFICER
Business Development, reimbursement strategy and launch rediness
David Eads
CHIEF FINANCIAL OFFICER
Finance, accounting, administration
INVESTORS
Raising Series A to fund
development, approval, and commercialization
Milestone-based financing to complete development, clinical validation, FDA submission, and commercial readiness for the first rapid FRAA test.
$6 Million
Manufacturing development and FDA pre-submission through early 2027.
$4 Million
Clinical study, FDA de novo submission, GMP scale-up, and reimbursement groundwork.
$15 Million
Commercial launch, early revenue generation, and market expansion.
GET INVOLVED
Invest in the
first rapid FRAA test
For investors seeking first-mover exposure to maternal diagnostics, fertility care, and neurodevelopmental testing infrastructure