# Early Detection through Novel OCEAN Technology - Ovarian Cancer Exosomal Analysis with Nanoplasmonics

> **NIH NIH U01** · MASSACHUSETTS GENERAL HOSPITAL · 2021 · $746,693

## Abstract

Extracellular vesicles (EVs) are a new class of circulating biomarker that promises non-invasive, real-time
cancer monitoring. Many studies have shown that i) EVs may function as reliable surrogates of parental cancer
cells, and ii) these vesicles can reﬂect global tumor burden, overcoming limitations of tumor heterogeneity and
sampling bias. Translating EV analyses into a clinically relevant cancer test, however, is limited by the lack of
standardized, practical methods. Conventional assay tools (e.g., ultracentrifugation, Western blotting, ELISA)
require large amounts of EVs and extensive processing, making them impractical for clinical workﬂows.
Moreover, variations in sample handling and testing protocols often lead to inconsistent and confounding
results. The goal of this proposal is to i) address such technical challenges in EV analyses, and ii) rigorously
evaluate EVs' clinical value as a novel biomarker for early detection of ovarian cancer. We formed a strategic
academic-industry partnership to achieve this goal: Exosome Diagnostics, an industry leader in EV-based
cancer diagnostics, offering ready capacity to develop and manufacture in-vitro diagnostic medical devices;
and the Center for Systems Biology at the Massachusetts General Hospital, a pioneer in developing novel
analytical technologies for EV analyses. These teams will bring their multidisciplinary expertise, innovative
technologies and complementary resources to carry out the following translational projects. First, we will
advance a standardized EV assay platform. We will adopt our recently developed ExoLution platform to
streamline EV collection, and the nPLEX (nano-plasmonic exosome) technology for high-throughput EV protein
screening. Our initial study showed that nPLEX achieved >1000-fold higher sensitivity than conventional
methods and yet consumed scant sample volumes (0.1 μL). We now seek to advance nPLEX to the instrument
level by i) improving its robustness and throughput, and ii) establishing standardized assay protocols.
Leveraging the developmental and regulatory expertise of Exosome Diagnostics, the resulting platform will be
ready for translation into clinical diagnostic laboratories. Second, we will perform a targeted clinical study,
particularly testing whether EVs can be exploited as a biomarker for early detection of ovarian cancer and
progression monitoring. Our preclinical study will use patient-derived ovarian cancer cells and novel genetically
engineered mouse models to identify EV protein signatures for ovarian cancer. We will next proﬁle circulating
EVs from ovarian cancer patients and assess the correlation between tumor burden and EV protein signature.
Our study will be designed to ensure assay reliability and reproducibility, thereby delivering clinically
translatable EV diagnostics. We will impose stringent quality controls on device design and sample processing,
accrue well-annotated patient and control samples, and perform multisite testing. The ...

## Key facts

- **NIH application ID:** 10223236
- **Project number:** 5U01CA233360-04
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Cesar M Castro
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $746,693
- **Award type:** 5
- **Project period:** 2018-09-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10223236

## Citation

> US National Institutes of Health, RePORTER application 10223236, Early Detection through Novel OCEAN Technology - Ovarian Cancer Exosomal Analysis with Nanoplasmonics (5U01CA233360-04). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10223236. Licensed CC0.

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