# AperionDx

> 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.

Founded 2015. Based in Carlsbad, California, USA.

## 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.
- **Scalable** — high-throughput testing for research and clinical settings with a
  1.5-4 hour turnaround time.

## 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** — quantifies Aβ40, Aβ42, pTau181 and pTau217. 97.5% PPA/NPA or
greater versus Simoa®/ELISA. Supports the potential to identify risk 10+ years before the
appearance of clinical symptoms.

**Traumatic brain injury (TBI)** — quantifies GFAP, ALDOC, NGRN, BDNF and ST2. 97.5%
PPA/NPA or greater agreement with established methods. Supports early assessment, risk
stratification and ongoing monitoring.

**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:
PPA 100% (AD) and 97.7% (TBI); NPA 97.5% (AD) and 100% (TBI).

## Sample types

Standard blood samples. Serum and plasma have already been qualified; other sample types
may be used but have not yet been qualified.

## Workflow

1. **Detect** — measure full panels of disease-specific biomarkers from blood samples at
   extremely low concentrations.
2. **Scale** — compatible with 96- and 384-well plates, processing up to 350 samples per plate.
3. **Deliver** — turnaround time (TAT) in 1.5-4 hours.

## Who it is for

Research labs, biotech companies, drug development, and the pharmaceutical industry.
Hospitals and clinics upon completion of FDA review of clinical data.

## Important qualifier

Use in hospitals and clinics for human diagnostics only applies upon completion of
clinical trials' data review and clearance by the FDA. AperionDx products are not
represented as FDA-cleared or FDA-approved.

## Extended reference

- [llms-full.txt](https://www.aperiondx.com/llms-full.txt): the complete substantive
  content of this site in one file, including all FAQs, leadership credentials, and an
  explicit note on the provenance and qualifiers of every performance claim.

## Pages

- [Home](https://www.aperiondx.com/): Overview of Protein-PCR and why it matters.
- [About Us](https://www.aperiondx.com/about-us/): Mission, vision and leadership team.
- [Products](https://www.aperiondx.com/products/): Alzheimer's and TBI assay panels.
- [Contact Us](https://www.aperiondx.com/contact-us/): Enquiries and contact details.

## Contact

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