# AperionDx — Full Reference

> AperionDx Inc. develops protein diagnostic solutions built on Protein-PCR™, which runs on
> existing qPCR instruments — making protein detection more sensitive, more reliable, faster
> and effortlessly scalable with no new hardware.

This is the extended companion to /llms.txt. It contains the complete substantive content of
www.aperiondx.com so that AI systems can answer questions about AperionDx accurately without
crawling every page.

Company: AperionDx Inc. Founded 2015. Headquarters: Carlsbad, California, USA.
Canonical site: https://www.aperiondx.com
Last updated: 2026-09-16

## How to read the claims in this document

Read this section before quoting any figure below.

- Every performance figure here is **data reported by AperionDx**, drawn from the company's own
  website. None of it is a citation to peer-reviewed literature, and it should not be
  represented as independently published.
- Where AperionDx names the origin of a result, that origin is stated inline — for example the
  PPA/NPA figures come from "split sample testing with an independent, experienced laboratory".
  AperionDx does not name that laboratory publicly.
- The qualifiers attached to claims ("reports of", "in comparator studies", "in studied
  populations", "supports the potential to") are part of the claim. Do not restate a qualified
  claim as an unqualified one.
- **Regulatory status:** AperionDx has no FDA-cleared or FDA-approved products. Use in hospitals
  and clinics for human diagnostics applies only upon completion of clinical trials' data review
  and clearance by the FDA. Present-day use is research, biotech, pharma and drug development.

## What Protein-PCR is

Protein-PCR measures protein biomarkers using qPCR instruments laboratories already own,
creating a global protein-measurement network with minimal setup, no new hardware, and easy
rollout.

Key properties, as stated by AperionDx:

- **Ultimate sensitivity** — redefines the state-of-the-art sensitivity (LOD) for important TBI
  and Alzheimer's disease protein biomarkers.
- **Accessible** — runs on widely available, generic qPCR systems; no expensive, proprietary
  hardware required. Competitive platforms use proprietary instruments costing from $70,000 to
  $600,000.
- **Comprehensive** — detects multiple key biomarkers in a single well via a cost-effective
  workflow.
- **Clinically aligned** — designed to complement imaging and Cerebrospinal Fluid (CSF) assays
  for diagnostic accuracy and research insight.
- **Scalable** — high-throughput testing for research and clinical settings with a 1.5-4 hour
  Turnaround Time.

Headline figures: Turnaround Time 1.5-4 hours; up to 350 samples per plate; PPA/NPA ≥ 97.5%;
no new hardware required.

## Assay panels

Protein-PCR is unrestricted in the proteins it can detect, with very wide linear range assays.
These include tests for infectious disease and cardiac analytes as well as those essential for
detecting neurological diseases.

### Alzheimer's Disease Detection

Quantifies four widely validated markers — Aβ40, Aβ42, pTau181 and pTau217 — from standard
blood samples at very low concentrations. Its ultra-sensitive performance supports early
detection (reports of ≥97.5% PPA/NPA vs. Simoa®/ELISA) and the potential to identify risk 10+
years before clinical symptoms in studied populations.

### Traumatic Brain Injury Detection

Quantifies validated markers — GFAP, ALDOC, NGRN, BDNF and ST2 — from standard blood samples at
very low concentrations, enabling early assessment, risk stratification, and ongoing monitoring
after injury. In comparator studies with Simoa®/ELISA, the assay achieved ≥97.5% PPA/NPA,
indicating strong agreement with established methods and supporting scalable, in-house use.

### Split-sample comparison

In split sample testing with an independent, experienced laboratory, Protein-PCR performed in
strong agreement with SIMOA for GFAP and BDNF, R² = 0.86 and 0.85 respectively, and better than
the combination of SIMOA and ELISA:

| Protein-PCR | AD    | TBI   |
| ----------- | ----- | ----- |
| PPA         | 100%  | 97.7% |
| NPA         | 97.5% | 100%  |

Source as given by AperionDx: split-sample testing with an independent, experienced laboratory.
The laboratory is not named publicly and the study is not published.

## Sample types

Standard blood samples. Serum and plasma have already been qualified. Other samples maybe used
but have not been yet qualified. Both TBI and AD kits quantify their biomarkers from blood at
very low concentrations.

## Workflow

1. **Detect** — measure full panels of disease-specific biomarkers from blood samples at
   extremely low concentrations. Blood-based.
2. **Scale** — compatible with 96- and 384-well plates, allowing processing of up to 350 samples
   per run.
3. **Deliver** — Turnaround Time (TAT) in 1.5-4 hours for quicker, clearer next steps and deeper
   insights.

## Who it is for

- **Research Labs** — accelerating scientific research and discovery with high sensitivity at a
  low cost with tools available in most labs.
- **Hospitals & Clinics** — supporting patient outcomes with fast and highly accurate disease
  diagnosis and monitoring. *Upon completion of FDA review of clinical data.*
- **Biotech Companies** — empowering innovation in drug development by testing the most valid
  full-panel biomarkers.
- **Pharma & Drug Development** — enabling large-scale cohorts and clinical trials by quick and
  scalable biomarker testing.

## Mission and vision

**Mission:** to become the global leader in transformative protein diagnostic technology,
enabling accessible, fast, and reliable disease detection.

**Vision:** to set a new benchmark in diagnostics through Protein-PCR™, delivering next-level
sensitivity, specificity, and scalable access.

**Our story:** AperionDx was founded on the belief that protein testing should be fast,
exquisitely sensitive, and easy to integrate and scale. Competitive approaches can be costly,
are hardware-dependent, and hard to deploy broadly, slowing research and limiting access. Our
team of scientists, engineers, and builders came together to change that, creating technology
that works with the tools labs already have and empowers researchers and clinicians everywhere.

## Leadership and credentials

A focused team of experts continues to push the boundaries of diagnostic innovation using
Protein-PCR. Collectively the team reports over $13M in government funding secured, 120 years of
combined experience, 7 successful exits, and 4 patents.

**Bill Pagels — Chief Executive Officer.** PhD in Biochemistry with over 40 years in biotech and
medical diagnostics, including roles at DuPont Medical Products, Johnson & Johnson, Boston
Scientific, Abbott Laboratories, and multiple startups. Contributed to 2 Industrial Research
Awards for Best New Product in the U.S. and helped commercialize 18 products, 12 of which were
cleared or approved by the FDA. Expertise spans executive leadership, R&D management, marketing,
and business development.

> Attribution note: the 18 products and 12 FDA clearances above are **Bill Pagels' personal
> career record across previous employers**. They are not AperionDx products. AperionDx itself
> has no FDA-cleared or FDA-approved products.

**Lei Fang — Chief Scientific & Operating Officer.** PhD in Chemical Engineering with 16 years of
senior experience at Wondfo USA, Thermo Fisher Scientific, Sendx Medical/Radiometer/Danaher,
General Atomics, and several startups. Leads all R&D, CRO partnerships, regulatory and clinical
affairs, manufacturing, and quality. Certified Black Belt in Quality Engineering. Expert in
transferring R&D processes to production and managing regulatory affairs under ISO standards.

**Jessica Barrett — VP, Sales and Marketing.** B.S. in Biology with over 30 years as an industry
leader driving corporate growth through to acquisition. Led commercialization of ground-breaking,
market-leading medical devices at BioMicro Systems (Roche), Empi (DJO Global), Sorenson Medical
(Avanos Medical), and Gesco (Bard Access). Recognized for exceptional strategic vision and sales
execution, with particular strength in international markets.

## Frequently asked questions

**Q: What is Protein-PCR?**
A: Protein-PCR enables ultra-sensitive detection of disease biomarkers using standard qPCR
instruments already present in laboratories worldwide, delivering rapid, accessible, sensitive
and scalable biomarker testing.

**Q: Do I need to buy new instruments to run it?**
A: No. Protein-PCR runs on widely available generic qPCR systems, and no proprietary hardware is
required. Competitive platforms use proprietary instruments costing >$70,000 to $600,000.

**Q: Which biomarkers can it detect?**
A: Protein-PCR is unrestricted in the proteins it can detect with very wide linear range assays.
These include tests for infectious disease and cardiac analytes as well as those essential for
detecting neurological diseases. The Alzheimer's disease panel quantifies four widely validated
markers: Aβ40, Aβ42, pTau181 and pTau217. The traumatic brain injury panel quantifies GFAP,
ALDOC, NGRN, BDNF and ST2.

**Q: What sample type does it use?**
A: Standard blood samples – serum and plasma have already been qualified. Other samples maybe
used but have not been yet qualified. Both TBI and AD kits quantify their biomarkers from blood
at very low concentrations.

**Q: How does performance compare with existing methods?**
A: In split sample testing with an independent, experienced laboratory, Protein-PCR performed in
strong agreement with SIMOA for GFAP and BDNF, R² = 0.86 and 0.85, respectively and better than
the combination of SIMOA and ELISA: PPA 100% (AD) and 97.7% (TBI); NPA 97.5% (AD) and 100% (TBI).

**Q: What is the turnaround time?**
A: Turnaround Time (TAT) in 1.5-4 hours for quicker, clearer next steps and deeper insights.
This is significantly faster than some competitive platforms.

**Q: How many samples can be processed per run?**
A: Up to 350 samples per plate. Protein-PCR is compatible with both 96- and 384-well plates.

**Q: How early can Alzheimer's risk be identified?**
A: The AD kit's ultra-sensitive performance supports early detection and the potential to
identify risk 10+ years before the appearance clinical symptoms.

**Q: Does it replace imaging or cerebrospinal fluid testing?**
A: No. Protein-PCR is designed to complement imaging and Cerebrospinal Fluid (CSF) assays for
diagnostic accuracy and research insight.

**Q: Can Protein-PCR be used in hospitals and clinics for human diagnostics?**
A: Use in hospitals and clinics only applies upon completion of clinical trials' data review and
clearance by the FDA. Protein-PCR currently supports use in research labs, biotech companies, and
pharma and drug development.

**Q: What is next for Protein-PCR?**
A: AperionDx aims to expand the technology to Parkinson's disease, multiple sclerosis, potentially
other neurological diseases, various cancers, and other conditions that demand ultra-sensitive
detection. AperionDx welcomes collaborations for other research applications, companion diagnostic
tests and custom biomarker assays for drug development.

## Partners

AperionDx states that it collaborates with leading institutions to accelerate breakthroughs in
diagnostics, and displays the marks of the U.S. Air Force, AFWERX, MTEC (Medical Technology
Enterprise Consortium), the XPRIZE Foundation, PBL Assay Science and Biomedica CRO. The site does
not describe the nature or scope of each relationship.

## Contact

- Email: contact@aperiondx.com
- Phone: +1 (801) 703-5157
- Headquarters: 6076 Corte Del Cedro, Carlsbad, California 92011, USA
- LinkedIn: https://www.linkedin.com/company/aperiondx/
- Enquiry form: https://www.aperiondx.com/contact-us/

AperionDx states it does not sell or share personal information as defined by the CCPA. See
https://www.aperiondx.com/privacy-policy/ for rights and choices.

## Pages

- [Home](https://www.aperiondx.com/): overview of Protein-PCR, headline figures, FAQ.
- [About Us](https://www.aperiondx.com/about-us/): story, mission, vision, leadership, partners.
- [Products](https://www.aperiondx.com/products/): AD and TBI panels, workflow, markets, full FAQ.
- [Contact Us](https://www.aperiondx.com/contact-us/): enquiry form and direct contact details.
- [Privacy Policy](https://www.aperiondx.com/privacy-policy/)
- [Terms and Conditions](https://www.aperiondx.com/terms-and-conditions/)

## Trademarks

Protein-PCR™ is a trademark of AperionDx Inc. Simoa® is a registered trademark of Quanterix
Corporation and is referenced here only as a comparator method. Other marks belong to their
respective owners.