# Micro-Organospheres Drug Screen to Lead Care (MODEL): a Precision Oncology Platform to Guide Breast Cancer Therapy

> **NIH NIH R44** · XILIS, INC. · 2022 · $398,486

## Abstract

PROJECT SUMMARY/ABSTRACT
The goal of precision oncology is to match cancer patients with medicines based on the specific biology of their
tumor. Crucially, the current precision oncology paradigm – which is largely based on tumor genomic profiling –
doesn’t work for the majority of patients. Since every patient’s tumor is uniquely complex, a potential solution to
this “precision” problem involves creating a viable functional model of a patient’s individual tumor in order to
directly test its susceptibility to different drugs. The broad adoption of such patient-derived functional models into
the clinic thus far has been hindered by several limitations centered on scalability, time, and success rate.
Specifically, any assay for guiding therapy must be: i) amenable to the amount of material derived from needle
biopsies, ii) established with a high success rate, and iii) completed within 10-14 days to minimize unacceptable
treatment delays. To address these clinical limitations, we have developed the novel Micro-Organosphere Drug
Screen to Lead Care (MODEL) platform. MODEL is based on novel microfluidics technology that generates
Patient-Derived Micro-Organospheres (PDMO) from clinical samples (e.g., biopsies) and performs drug
screening within 10 days to guide therapy. The objective of our proposal is to further develop and validate our
MODEL technology in breast cancer, with a view to advancing it further towards becoming a standard of care
diagnostic assay. Phase I of our proposal will focus on preparing our MODEL device for rigorous clinical
evaluation. In Aim 1 we will make key upgrades to our device prototype to improve sample efficiency, device
performance, and operability. Specifically, the goal of these improvements will be to reduce sample size
requirements (extending our capabilities down to fine-needle aspirates), enhance device performance, reinforce
consistency of key parameters during and between runs, and increase process automation. In Aim 2, we will
rigorously test the ability of our second-generation device to i) successfully generate PDMO from breast cancer
biopsies and ii) perform drug screens in less than 10 days total. In Phase II, we will make key device upgrades
to prepare the MODEL platform for commercialization, focusing on improving features related to data integrity
and ease-of-use (Aim 1). In Aim 2 we will perform the first validation of our MODEL platform in a HER2+ breast
cancer clinical protocol consisting of 50 patients, with the goal of testing MODEL’s ability to predict response to
standard of care neoadjuvant therapy. If successful, the development of our platform will revolutionize
precision oncology by arming oncologists with the information needed to optimally match cancer patients with
medicines.

## Key facts

- **NIH application ID:** 10383051
- **Project number:** 1R44CA261579-01A1
- **Recipient organization:** XILIS, INC.
- **Principal Investigator:** Daniel Delubac
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $398,486
- **Award type:** 1
- **Project period:** 2022-05-09 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10383051

## Citation

> US National Institutes of Health, RePORTER application 10383051, Micro-Organospheres Drug Screen to Lead Care (MODEL): a Precision Oncology Platform to Guide Breast Cancer Therapy (1R44CA261579-01A1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10383051. Licensed CC0.

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