# Lung Cancer Screening via Ultrasensitive and Cost-efficient Analysis of Tumor DNA Signatures in Blood

> **NIH NIH U01** · YALE UNIVERSITY · 2022 · $947,748

## Abstract

PROJECT SUMMARY
Substantial improvements in cancer survival rates could be achieved by developing better tools to detect occult
malignancies at an earlier, more curable stage. Unfortunately, efforts to identify serum protein biomarkers that
are sufficiently cancer-specific to be used for screening have found little success. Here, we pursue an
alternative strategy based on detection of exceptionally tumor-specific mutant DNA fragments in the circulation
of patients with early-stage lung cancer. Because these tumor-derived DNA fragments harbor genetic
signatures that would be uncommon in healthy individuals, they hold great promise for screening applications
where a high frequency of false-positive results would be unacceptable. However, it is a formidable challenge
to create an assay that is able to detect trace quantities of mutant DNA released into the bloodstream from a
small, early-stage tumor, without knowing the tumor’s mutation profile beforehand. Additional challenges are
posed by economic factors as well as the presence of low-level mutations in the healthy population. To
address these challenges, we have assembled a multidisciplinary team with highly complementary expertise
from Microsoft Research and from Yale, Rice, and Harvard Universities. In this proposal, we describe
innovative solutions in which we apply tools of biochemistry, thermodynamics, machine learning, and
biostatistics to develop and validate an ultrasensitive, cost-efficient assay for detecting rare mutant DNA
fragments in blood as markers of early-stage lung cancer.

## Key facts

- **NIH application ID:** 10478168
- **Project number:** 5U01CA233364-05
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Abhijit Patel
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $947,748
- **Award type:** 5
- **Project period:** 2018-09-06 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10478168

## Citation

> US National Institutes of Health, RePORTER application 10478168, Lung Cancer Screening via Ultrasensitive and Cost-efficient Analysis of Tumor DNA Signatures in Blood (5U01CA233364-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10478168. Licensed CC0.

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