# Translating a Novel Assay for Risk Stratification of Potentially Malignant Pancreatic Cystic Lesions

> **NIH NIH R43** · AMPLIFIED SCIENCES INC · 2024 · $55,000

## Abstract

1. Executive Summary
Pancreatic cancer has a depressing 5-year survival rate estimated at 12%. The dismal outlook is
due to myriad issues, including the fact that patients are asymptomatic in early stages combined
with the lack of screening tools. One window to earlier detection is through pancreatic cystic
lesions detected incidentally in routine imaging analyses for diagnosis of unrelated disorders.
These patients are at an increased risk for pancreatic cancer. Unfortunately, imaging is insufficient
for distinguishing benign cysts from those likely to progress to cancer forcing clinicians to rely on
biochemical analyses of acellular cyst fluid. The current assays display poor accuracy and require
large volumes of fluid not always available limiting their clinical utility. There is a profound unmet
clinical need for diagnostics that accurately grade dysplasia in mucinous pancreatic cyst fluids.
The objective of current SBIR Phase I grant (CA277913-01A1 effective May 2023) is to develop
and conduct clinical translation of a diagnostic assay panel using ultrasensitive detection methods
to grade dysplasia in pancreatic cysts. This assay will stratify
patients most at risk for progression to cancer thus providing high clinical utility.
The platform: Amplified Sciences has utilized a proprietary platform to translate to the company
roscopy platform is robust and readily
adaptable to other proteolytic enzymes as needed for this grant. To date, the company has made
strong progress on the Aims. The team has built a new direct-detection SERS ligand binding
platform (prototype stage) for two of the biomarkers, and adapted the existing enzymatic activity
assay for a third. Over 90 retrospective clinical samples have been procured, and all clinical
testing and statistical analysis should be complete by end of Phase 1. The company is on track
-ready assay protocol for full clinical validation and algorithm development in a
Phase 2 grant.
Several challenges have been met and overcome. Technical challenges including delays in the
supply chain have been overcome by securing new suppliers for chemicals, etc. Administrative
challenges include delays from securing invoices from vendors, so more frequent reminders have
been implemented. Finally, commercial challenges include limited funding for market research
with doctors and payers to gain the insights needed to prepare for commercial launch and
challenges in accessing clinicians at large academic centers. To overcome this, the company has
leveraged current clinical investigators for introductions. Finally, the current capital market for
fundraising is very challenging so the company has supplemented investor funds with non-dilutive
funding totaling $1M of research use only revenue and state and federal grants.
Specific Aims:
Aim 1: Validate a combination of three (3) protease activity markers to accurately distinguish
low- grade from high-grade mucinous pancreatic cystic neoplasms.
Aim 2: To develop quantitative...

## Key facts

- **NIH application ID:** 11020848
- **Project number:** 3R43CA277913-01A1S1
- **Recipient organization:** AMPLIFIED SCIENCES INC
- **Principal Investigator:** Daniel Sheik
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $55,000
- **Award type:** 3
- **Project period:** 2023-05-01 → 2024-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11020848

## Citation

> US National Institutes of Health, RePORTER application 11020848, Translating a Novel Assay for Risk Stratification of Potentially Malignant Pancreatic Cystic Lesions (3R43CA277913-01A1S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11020848. Licensed CC0.

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