Innovation Focus

Amplified’s approach uses ultrasensitive optical reporters to detect specific biomarkers in pancreatic cyst fluid that indicate cancer risk. The lead assay, PanCystPro, is designed to measure three complementary markers — gastricsin enzyme activity (via the BioMatra platform), carcinoembryonic antigen (CEA), and glucose — designed to stratify pancreatic cysts by risk.

This strategy aims to:

• Distinguish potentially cancerous mucinous cysts from benign non-mucinous cysts
• Reduce unnecessary surgery for patients with benign cysts
• Enable earlier intervention or closer monitoring for patients with higher-risk mucinous cysts
• Support more informed care decisions through more objective cyst risk assessment

Clinical Progress

In a multi-site IRB-approved study of approximately 136 pathologically confirmed cyst samples, PanCystPro showed diagnostic accuracy in the low-to-high 90 percent range, with high sensitivity, specificity, and very strong negative predictive value for ruling out mucinous cysts.

Amplified is also advancing a complementary “rule-in” assay, PanHGLG, designed to grade dysplasia in confirmed mucinous cysts. Pilot data from 71 pathologically confirmed samples — funded in part by a National Cancer Institute SBIR grant — generated performance metrics generally in the high 70 to high 90 percent range across accuracy, sensitivity, and negative predictive value.*

Together, PanCystPro and PanHGLG are designed to form an integrated algorithm capable of determining both whether a cyst is mucinous and whether it harbors high-grade dysplasia warranting surgical resection versus low-grade dysplasia suitable for surveillance.

Amplified is now advancing a mutli-site clinical utility study designed to link test results to clinical management decisions and outcomes — a prerequisite for broad payer coverage — and is pursuing a Medicare PLA code and CMS crosswalk pricing.

*Pilot data on 71 samples accepted as poster presentation at ADLM 2025.

Founder

Amplified was founded by Diana Caldwell, MBA, a serial diagnostics and life sciences entrepreneur with prior experience in commercial launches and strategic partnering, and V. Jo Davisson, PhD, a biochemist with roughly 30 years of R&D experience across academia and industry.

Davisson’s research at Purdue University generated the core science behind BioMatra — a proprietary Surface Enhanced Raman Spectroscopy dye chemistry designed to measure enzyme activity and other biomarker signals at a level of sensitivity previously impossible for the small sample volumes obtained from pancreatic cyst fluid analysis. Caldwell has led the translation of that science from Purdue’s laboratory into a CLIA-certified laboratory in California and toward a clinical utility study designed to secure payer coverage.

Caldwell serves as Amplified’s Chief Executive Officer. Davisson serves as Chief Scientific Officer and Board Member.

Strategic Rationale

The investment aligns with Cancer Fund I, LLC’s strategy of deploying capital into oncology innovations positioned to advance through defined clinical and regulatory milestones.

Amplified represents:

• An early-stage diagnostic asset pursuing and clinical validation and a defined path to payer coverage
• A targeted approach to pancreatic cancer, where early detection and risk stratification remain critical unmet clinical needs
• A platform technology that is potentially extensible across additional cancer and chronic-disease indications where enzyme activity and multiplex biomarker panels may enable earlier or more precise diagnosis

The investment also reflects the Fund’s role in supporting continued clinical progression alongside other institutional and non-dilutive funding sources, including NIH SBIR grants and state innovation funding.

Impact Thesis

Amplified Sciences is advancing a diagnostic platform aimed at improving cancer detection and management for patients with pancreatic cystic lesions — one of the most challenging cancer risk populations to accurately stratify. It is estimated that 5% to 15% of American adults could have pancreatic cycles. The cysts are often discovered incidentally on imaging ordered for unrelated reasons, yet current cyst fluid analysis often fails to distinguish benign from potentially cancerous lesions.

By offering more precise, more objective cyst risk assessment, Amplified’s innovation has the potential to:

• Reduce unnecessary surgery and surveillance for patients with benign cysts
• Enable earlier intervention for patients with high-risk mucinous cysts
• Support more informed management decisions at tumor boards and multidisciplinary pancreatic cyst clinics
• Expand to additional cancer and chronic disease indications through the BioMatra chemistry

What We’re Tracking

Consistent with CANCER FUND’s impact and investment framework, progress evaluation may include:

• Completion of analytical and clinical validation studies
• Progress on the multi-site clinical utility study
• Successful filing of a Medicare PLA code and CMS crosswalk pricing decision
• Non-dilutive funding attraction and CLIA lab operational scale-up
• Platform expansion to additional cancers and biomarker panels

Community Signal

This investment reflects engagement from CANCER FUND’s community of physicians, researchers, patients, and investors who participated in the evaluation process. 73 members of CANCER FUND’s Screening Committee evaluated Amplified Sciences during our review process. Community feedback was strongly positive — 69% of respondents perceived Amplified as having significant impact potential for patients, with an additional 29% perceiving some impact potential. 81% of respondents indicated that CANCER FUND should further consider Amplified Sciences for investment.

Role in the Portfolio

Amplified Sciences is one of Cancer Fund I’s early-stage diagnostic investments, expanding the Fund’s support of platform technologies designed to improve pancreatic cancer detection and risk stratification. The investment contributes to a diversified portfolio strategy focused on advancing multiple approaches to improving cancer outcomes across indications and modalities.

Why This Investment Matters

Pancreatic cancer is the third leading cause of cancer death in the United States and projected to become the second by 2030. The five-year survival rate remains at roughly 13 percent — the lowest of any major cancer. More than 66,000 Americans will be diagnosed this year, and approximately 52,000 will die from the disease.

These are the numbers that make pancreatic cancer one of the hardest places to move the needle — and one of the places CANCER FUND is deploying capital.

Amplified Sciences is one of the innovations our community has supported with an investment through Cancer Fund I, LLC. See our full portfolio at cancerfund.com/portfolio.