# Advancing EFIRM-Liquid Biopsy (eLB) to a CLIA-Certified Laboratory Developed Test (eLB-LDT) for Detection of Actionable EGFR Mutations in NSCLC Patients

> **NIH NIH UH3** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 · $390,000

## Abstract

Project Summary/Abstract:
Malignant transformation of normal cells are driven by oncogenic mutations of key cellular genes where
therapeutics are actively being developed to target these mutations for interventions that will improve morbidity
and/or mortality. The current clinical practice to interrogate these “actionable mutations” is by tumor biopsy
followed by genotyping which is invasive and at times access restrictive, challenging, subject to sampling errors
and may simply not possible. Liquid biopsy is a rapidly emerging field to access actionable mutations in tumors
minimal/non-invasively in bodily fluids based on circulating tumor DNA (ctDNA).
This UH2/UH3 application is responsive to the PAR-15-095 to advance the translational and clinical development
of a matured academic laboratory assay, the EFIRM-Liquid Biopsy (eLB) to a “Clinical Laboratory Improvement
Amendment” (CLIA)-certified laboratory developed test (eLB-LDT), in the UCLA Molecular Diagnostic
Laboratories (MDL), a CLIA-certified/ College of American Pathologists (CAP)-accredited Laboratory. The eLB-
LDT will be evaluated in a clinical context of use to interrogate actionable mutations in the EGFR gene of NSCLC
patients at the VA Greater Los Angeles Healthcare System (VA GLA).
It is important to advance academic assays for cancer detection, diagnosis and treatment to regulated clinical
assays that will provide novel capabilities to physicians to impact health of their patients. Our proposal is to
advance a matured academic assay, EFIRM-Liquid Biopsy (eLB) that delivers the best performance technology
to detect oncogenic mutations, to become a CLIA-certified laboratory developed test (LDT), the EFIRM-Liquid
Biopsy laboratory developed test (eLB-LDT). eLB detects actionable EGFR mutations in NSCLC patients with
100% concordance with biopsy-based genotyping, outperforms current technologies for liquid biopsy. The
clinical validation study will be conducted at the UCLA Medical Center and VA Greater Los Angeles Healthcare
System (VA GLA) where 20% of patients with adenocarcinoma subtype of non-small cell lung carcinoma
(NSCLC) harbor TKI-responsive mutations in the EGFR gene. The eLB-LDT technology if validated, may replace
current practice of liquid biopsy for EGFR genotyping as it has the best performance, minimal or non-invasive,
rapid, inexpensive and self-contained permitting the detection of the most common EGFR gene mutations that
are treatable with TKI such as Gefitinib or Erlotinib to effectively extend the progression free survival of lung
cancer patients.
 Two Specific Aims are in place to achieve these goals. Aim 1/UH2 is to adapt the academic EFIRM-Liquid
Biopsy (eLB) technology to become a CLIA-certified assay in the UCLA Diagnostics Molecular Pathology
Laboratory and to determine analytical and clinical performance. Aim 2/UH3 is to analytically and clinically
validate eLB-LDT at the clinical sites (UCLA and VA GLA).

## Key facts

- **NIH application ID:** 10111468
- **Project number:** 5UH3CA206126-05
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** David S. Chia
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $390,000
- **Award type:** 5
- **Project period:** 2017-03-06 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10111468

## Citation

> US National Institutes of Health, RePORTER application 10111468, Advancing EFIRM-Liquid Biopsy (eLB) to a CLIA-Certified Laboratory Developed Test (eLB-LDT) for Detection of Actionable EGFR Mutations in NSCLC Patients (5UH3CA206126-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10111468. Licensed CC0.

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