# Advanced Development of the MasSpec Pen for Cancer Diagnosis and Surgical Margin Evaluation

> **NIH NIH R33** · BAYLOR COLLEGE OF MEDICINE · 2021 · $485,413

## Abstract

ABSTRACT: Tissue diagnosis is critical during surgical removal of solid cancers for margin evaluation and
optimal excision. Complete resection of the tumor is associated with an improved prognosis for almost all types
of solid malignancies. However, the standard clinical approach for intraoperative assessment of extent of tumor
excision, frozen section analysis, can be subjective, require on site specialty pathology expertise, is labor- and
time- consuming, and exposes patients to increased risks of anesthesia and surgical site infection. Our team has
reported the development of a highly innovative handheld and biocompatible mass spectrometry device, the
“MasSpec Pen”, for rapid and non-destructive diagnosis of ex vivo and in vivo tissues (Zhang et al, Science
Translational Medicine, 2017, 9, eaan3968). The MasSpec Pen provides the unique and transformative ability
to assess molecular predictors of disease state directly from tissue samples without causing harm or damage to
the tissues and in seconds. We believe the MasSpec Pen offers substantial improvements over existing
technologies and represents an advance that is so innovative that will become a disruptive leap forward for
intraoperative use in cancer diagnosis and margin evaluation. In collaboration with surgeons and pathologists at
the Baylor College of Medicine, we propose to further develop and validate the MasSpec Pen within the context
of its intended intraoperative use in surgical margin evaluation. The objectives of this proposal include:
Aim 1. Optimize the MasSpec Pen for breast and pancreatic cancer detection. The MasSpec Pen provides
near real time molecular detection capabilities for cancer diagnosis along with operational features that are
attractive for clinical use. Technical refinements will be pursued to improve performance for intraoperative use,
and to further determine and develop detection capabilities at various tumor cell concentration and tissue depths
(Aim 1a). Performance measures (e.g. sensitivity and reproducibility) will be systematically evaluated. Statistical
classifiers will be expanded considering aspects of tumor heterogeneity, refined, and their performance
(sensitivity, specificity and accuracy) further validated using independent sample sets (Aim 1b).
Aim 2. Validate the MasSpec Pen for intraoperative cancer diagnosis and surgical margin evaluation.
The demonstration that the MasSpec Pen allows in vivo cancer diagnosis and surgical margin evaluation has
profound clinical implications. Technical validation of cancer detection capabilities and final tuning of the
technology for in vivo use will be pursued during breast (Aim 2a) and pancreatic (Aim 2b) cancer surgeries at
Baylor College of Medicine. Predictive diagnosis and surgical margin status will be compared to clinical results
for the same patients using standard clinical approaches to evaluate its clinical usefulness for clinical use.

## Key facts

- **NIH application ID:** 10462343
- **Project number:** 7R33CA229068-03
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** Livia Schiavinato Eberlin
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $485,413
- **Award type:** 7
- **Project period:** 2021-08-05 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10462343

## Citation

> US National Institutes of Health, RePORTER application 10462343, Advanced Development of the MasSpec Pen for Cancer Diagnosis and Surgical Margin Evaluation (7R33CA229068-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10462343. Licensed CC0.

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