First-to-Market FDA Pathway Underway

The first rapid
test for folate
autoantibodies

NeuroLume™ is bringing the nation's first point-of-care FRAA test to fertility clinics, OB-GYN offices, and pediatric practices — delivering answers in 10 minutes that standard panels have never been able to provide.

Micoy Therapeutics
×
Beacon Scientific
Joint Venture
See How It Works Investor Information
Rapid Lateral Flow Test
T
C
FRAA Positive Detected
10
minutes to result
1 in 36
Children with ASD (US)
$2.5B+
Infertility Diagnostics Market
0
FDA-Cleared FRAA Tests Exist
$3B+
US Autism Care Spending/yr
First-Mover Advantage
Lateral Flow Platform
Maternal Health & Fertility
Autism Risk Detection
Breakthrough Device Pathway
Folinic Acid Intervention
>1M Units/Month Manufacturing Capacity
The Problem

Hidden antibodies.
Devastating outcomes.
No rapid test.

Folate receptor autoantibodies — known as FRAAs — silently block the transport of folate to the developing fetus and brain. This happens even when a patient's serum folate levels appear completely normal. Standard prenatal bloodwork will not find them. Standard folate supplements will not fix them.

The consequences are severe and far-reaching. FRAAs are linked to miscarriage and recurrent pregnancy loss, neural tube defects, unexplained infertility, and increased risk of autism spectrum disorder. For millions of families, these outcomes arrive without warning and without explanation — because the test to detect their root cause has never existed at the point of care.

Approximately 1 in 36 children in the United States is diagnosed with autism. Millions of couples face unexplained infertility or repeated pregnancy loss with no actionable answer. In many of these cases, FRAAs may be the underlying and treatable cause.

The only existing FRAA test is not FDA-approved. The incumbent FRAT® test is limited to a single centralized laboratory, requires days to weeks for results, carries minimal payer coverage, and has seen almost no commercial adoption outside niche research settings. The market for a rapid, validated, point-of-care alternative is wide open — and entirely uncontested.

Conditions Linked to FRAAs
Landscape

The market already accepts blood-based
prenatal screening. FRAAs are the missing layer.

Blood-based prenatal testing is not a new idea — it is already deeply embedded in standard obstetric care. Chromosomal screening, single-gene inherited condition panels, and carrier screens are ordered by millions of OBGYNs every year. The infrastructure, the clinical acceptance, and the patient awareness are all in place. What is conspicuously absent from every one of these panels is immunological transport testing — the detection of folate receptor autoantibodies that silently disrupt fetal development regardless of what any genetic test reports.

1 in 3
US OBGYNs already order
blood-based prenatal NIPT

The clinical channel for blood-based prenatal diagnostics is proven, scaled, and receptive to expanded panels.

21
Genes now in single-gene
prenatal panels (and growing)

The field has moved from chromosomal to single-gene inherited conditions — but immunological barriers remain untested.

70%
of Down syndrome cases occur
in mothers under 35

Risk-based screening misses most cases. Universal screening is the direction of the field — and of FRAA testing.

5–7d
Typical lab-based prenatal
result turnaround time

NeuroLume's 10-minute point-of-care result is a paradigm shift in how quickly actionable answers can reach clinicians.

The prenatal diagnostics industry has proven the model: blood-based screening from a simple maternal draw, processed rapidly, returning actionable results that change clinical decisions. Chromosomal conditions. Single-gene disorders. RhD status. Preeclampsia risk. The field keeps expanding — and every expansion has found a waiting market. Folate receptor autoantibody testing is next, and NeuroLume is first.

The Test

ELISA precision.
10-minute results.
Point-of-care scale.

NeuroLume has taken the gold-standard ELISA methodology for FRAA detection and adapted it into a rapid lateral flow format — the same platform technology that powers modern pregnancy tests, flu tests, and COVID-19 rapid diagnostics. The result is a test that delivers clinically meaningful FRAA detection in 10 minutes, from a simple blood draw, at the point of care. No sample shipping. No waiting days. No referrals to niche labs. Just an answer — in the room, at the visit, when it matters most.

01

Rapid Lateral Flow

Micoy Therapeutics adapted the validated ELISA method for FRAA detection onto a lateral flow strip. Clinicians get a clear qualitative result in 10 minutes from a standard blood sample — no laboratory infrastructure required.

02

Blocking & Binding Detection

NeuroLume's platform detects both blocking and binding autoantibody subtypes — the two distinct mechanisms by which FRAAs impair folate receptor function. Comprehensive characterization in a single test.

03

Actionable at Every Step

A positive FRAA result directly enables intervention: folinic acid therapy, enhanced prenatal monitoring, and targeted neurodevelopmental support. Early detection gives clinicians and families the window to act.

10 min
Time to Result
Blood
Sample Type
POC
Point-of-Care
BDD
FDA Pathway
Who It's For

Designed for the
clinicians who need it most

NeuroLume is designed to integrate into the practices where FRAA screening matters most — without adding complexity, cost, or delay to your existing workflow.

Fertility Specialists & REIs

For patients presenting with unexplained infertility or recurrent implantation failure, FRAA screening offers a new diagnostic lens. A 10-minute in-office test can identify a treatable immune-mediated barrier that standard fertility workups completely miss.

OB-GYNs & Maternal-Fetal Medicine

Pre-conception and first-trimester FRAA screening adds a powerful layer to standard prenatal care. For patients with prior pregnancy loss or neural tube defect history, early identification enables folinic acid supplementation before the critical window closes.

Pediatric Neurologists & Developmental Pediatricians

In children presenting with autism, developmental regression, or cerebral folate deficiency, FRAA testing provides biological confirmation and opens the door to folinic acid intervention — one of the few targeted treatments with documented clinical response.

Integrative & Functional Medicine

For clinicians working at the intersection of immunology, nutrition, and neurodevelopment, FRAA testing adds precision to the folate conversation — moving beyond serum levels to the underlying transport biology.

How It Works in Your Practice
1

Order

Simple requisition form. No complex registration required to begin ordering.

2

Test

Standard blood draw. Results in 10 minutes at the point of care.

3

Report

Clear qualitative result with clinical interpretive guidance included.

4

Act

Folinic acid therapy, specialist referral, and enhanced monitoring as indicated.

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.

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.

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.

Dr. Edward Quadros — Scientific Founder

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.

Peer-Reviewed Evidence

The science behind
every test we produce

NeuroLume™ is built on decades of peer-reviewed research by Dr. Edward Quadros, the discoverer of folate receptor autoantibodies, and leading collaborators worldwide. The following published studies establish the clinical significance of FRAAs and the efficacy of folinic acid intervention.

01  ·  Dev. Med. Child. Neurol. 2008

Ramaekers, V.Th., Sequeira, J.M., Blau, N., Quadros, E.V. (2008) A milk-free diet downregulates folate receptor autoimmunity in cerebral folate deficiency syndrome. Dev. Med. Child. Neurol. 50, 346–352.

02  ·  Nutrients 2022

Ramaekers, V.Th., Quadros, E.V. (2022) Cerebral Folate Deficiency Syndrome: Early Diagnosis, Intervention and Treatment Strategies. Nutrients. 14(15), 3096.

03  ·  Biochimie 2016

Desai, A., Sequeira, J.M., Quadros, E.V. The metabolic basis for developmental disorders due to defective folate transport. Biochimie. (2016) S0300-9084(16)00055-9.

04  ·  Mol. Psychiatry 2018  ·  Randomized Controlled Trial

Frye, R.E., Slattery, J., Delhey, L., Furgerson, B., Strickland, T., Tippett, M., Sailey, A., Wynne, R., Rose, S., Melnyk, S., James, S., Sequeira, J.M., Quadros, E.V. (2018) Folinic acid improves verbal communication in children with autism and language impairment: a randomized double-blind placebo-controlled trial. Mol. Psychiatry. 23, 247–256.

05  ·  Biochimie 2020  ·  Randomized Controlled Trial

Renard, E., Leheup, B., Guéant-Rodriguez, R.M., Oussalah, A., Quadros, E.V., Guéant, J.L. (2020) Folinic acid improves the score of Autism in the EFFET placebo-controlled randomized trial. Biochimie 173, 57–61.

06  ·  J. Pers. Med. 2021  ·  Systematic Review & Meta-Analysis

Rossignol, D.A., Frye, R.E. (2021) Cerebral Folate Deficiency, Folate Receptor Alpha Autoantibodies and Leucovorin (Folinic Acid) Treatment in Autism Spectrum Disorders: A Systematic Review and Meta-Analysis. J. Pers. Med. 11, 1141.

"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.

Backed by Beacon Scientific's existing manufacturing infrastructure — currently producing rapid diagnostics at over 1 million units per month — NeuroLume™ has the operational capability to move from prototype to national scale without building from scratch.

2025–26
Foundation
  • Breakthrough Device Designation (BDD) with FDA
  • Prototype completion & analytical validation
  • Joint venture with Beacon Scientific for manufacturing
2027
FDA & Payers
  • FDA 510(k) submission
  • Payer engagement & reimbursement pathway
  • Multi-site clinical validation
Jan 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
The Joint Venture

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.

Therapeutics & Science

Micoy Therapeutics

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
Clinical Strategy
Regulatory Affairs
Neurodevelopment
Manufacturing & Distribution

Beacon Scientific

Beacon Scientific brings the operational backbone that transforms a validated assay into a nationally deployed diagnostic product. With expertise in lateral flow platform technology, scalable manufacturing, CLIA laboratory operations, and diagnostics commercialization, Beacon ensures NeuroLume can move from prototype to market — and from market to scale — with speed and precision.

Lateral Flow Mfg.
CLIA Operations
Distribution
Scale-up
NeuroLume™
A Joint Venture in Folate Autoantibody Diagnostics
"Together, we are making the invisible visible — identifying an immunological barrier that has silently affected millions of patients without a name, without a test, and without a path to treatment."
Micoy Therapeutics
×
Beacon Scientific
Leadership

A team that has
done this before

Proven at Every Stage of Diagnostics Commercialization

The NeuroLume™ team brings end-to-end diagnostic infrastructure that most startups spend years building. Beacon Scientific currently manufactures rapid diagnostics with capacity exceeding 1 million units per month. The team has the full infrastructure to develop, manufacture, and commercialize NeuroLume™ — from assay development and regulatory submission through to national distribution at scale. This is not a startup building from scratch. The factory is ready.

Manufacturing Capacity >1M Units / Month — Infrastructure Ready Now

Prem

CEO, Micoy Therapeutics

Leads Micoy Therapeutics with deep expertise in diagnostics commercialization, clinical strategy, and translating frontier science into scalable health solutions. Architect of the NeuroLume™ joint venture.

AJ

CEO, Beacon Scientific

Leads Beacon Scientific's manufacturing and distribution operations. Beacon currently produces rapid diagnostics with capacity exceeding 1 million units per month — giving NeuroLume™ proven infrastructure to develop, manufacture, and commercialize at national scale from day one.

Dr. Edward Quadros

Founder & Scientific Director, FRAA

Discoverer of folate receptor autoantibodies. One of the world's foremost authorities on FRAA biology, cerebral folate deficiency, and the clinical consequences of impaired folate transport. His foundational research underpins every test NeuroLume™ produces.

Investors

$10M Seed Round &
SAFE opportunity

NeuroLume™ is raising a $10 million seed round to complete prototype development, execute clinical validation, advance regulatory readiness, and expand our intellectual property estate. An optional $100,000 SAFE note is also available for investors seeking to accelerate the FDA pre-submission process and Breakthrough Device Designation request.

We are not asking investors to take a leap of faith on an unproven team in an unproven market. We are offering early-stage access to a first-mover diagnostic platform, backed by the world's leading FRAA scientist, built by a team that has already executed a rapid diagnostics exit, in a market with no approved competition and three large addressable segments.

$10M
Seed round — prototype, clinical validation, IP, regulatory readiness
$100K
Optional SAFE — FDA pre-submission & BDD acceleration
Jan '28
First revenue target — fertility & autism centers
BDD
Breakthrough Device Designation pathway
SAFE Return (Illustrative)

Early investors positioned for significant upside

Based on comparable diagnostics acquisitions, early SAFE investors in NeuroLume could plausibly see illustrative returns of 5× to 15× — or greater in a premium exit — over a 5 to 7 year horizon, depending on execution, dilution, and market conditions. This is illustrative and not guaranteed.

5×–15×
Illustrative SAFE return range
based on comparable exits
Comparable exits: Exact Sciences / Thrive $2.15B · Hologic / Gen-Probe $3.7B · Thermo Fisher / Mesa Biotech up to $550M · Qiagen / NeuMoDx $248M. Illustrative only — not a guarantee.
Get Involved

Invest in the
first rapid FRAA test

Whether you are a clinician ready to bring FRAA screening to your practice, an investor looking for first-mover exposure to maternal diagnostics, or a potential strategic partner — we want to hear from you. NeuroLume™ is raising a $10M seed round now.

Investor Inquiry Order the Test / Clinician Portal Download Investor Summary