Wren Laboratories
Wren Laboratories is a CLIA, CAP, NYSDOH and ISO15189-certified clinical testing and R&D laboratory specializing in mRNA liquid biopsy diagnostics for cancer.
Last updated September 27, 2026
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Overview
Wren Laboratories is a United States-based clinical testing and research-and-development laboratory focused on molecular liquid biopsy cancer diagnostics. Established in 2014 in Branford, Connecticut, the laboratory was founded as a commercial extension of decades of academic and medical research into non-invasive liquid biopsy tests for a wide variety of cancers and other diseases detectable through molecular biomarkers such as messenger RNA (mRNA). The company describes itself as a CLIA, CAP, NYSDOH and ISO15189-certified laboratory. Wren Laboratories' core technology is a proprietary RNA stabilization and testing platform that uses mRNA profiling to provide a functional view of tumor biology. Rather than relying solely on gene mutation detection through next-generation sequencing, the company's diagnostics measure mRNA activity — the dynamic link between genome abnormalities and disease behavior. According to the company, mRNA carries a gene's instructions, mutated or not, into biological action, and RNA profiling can detect aberrations in signaling pathways that drive tumor behavior. These insights are positioned to support drug development teams and cancer care providers in making more informed therapeutic decisions. The company's test portfolio centers on multi-gene mRNA expression technology for real-time, non-invasive cancer diagnostics, personalized treatment planning and patient monitoring. Its principal offerings include the NETest® and NETest® 2.0 for neuroendocrine cancer, the NETest PPQ® 2.0 (PRRT Predictive Quotient) for predicting response to peptide receptor radionuclide therapy, and PROSTest® for prostate cancer. These tests are marketed for applications including diagnosis and risk stratification, post-surgical disease status and minimal residual disease (MRD) detection, recurrence detection, and therapy response monitoring. Wren Laboratories serves both clinical and research markets. It provides tests for patients and oncologists, and it supports biopharma and research organizations in precision drug discovery and development. The company has also established international activity, including setting up NETesting at Sarah Cannon in the United Kingdom in 2019. Its history includes regulatory milestones such as a New York State Department of Health permit for NETest® in 2018, California Department of Health permit for NETest® in 2018, CLIA laboratory certification in Connecticut in 2014, CAP certification in 2022, and NYSDOH approval of PROSTest® in 2025. During the COVID-19 pandemic, the laboratory received FDA Emergency Use Authorization for SARS-CoV-2 testing via nasopharyngeal swab in 2019 and saliva PCR testing in 2020. Wren Laboratories remains a private company headquartered in Branford, Connecticut. Its stated mission is to transform cancer diagnostics through innovative liquid biopsy mRNA technology, using machine learning and liquid biopsy-RNA technologies to enhance detection of minimal residual disease, predict and monitor cancer response to therapies, and improve disease prognosis and outcomes.
History
Wren Laboratories was established in July 2014 in Branford, Connecticut, as a clinical laboratory. In October 2014, the laboratory received clinical laboratory certification in Connecticut and a CLIA license for the NETest®. The company describes itself as having been founded as a commercial extension of decades of academic and medical research into non-invasive liquid biopsy tests for cancers and other diseases detectable via molecular biomarkers such as mRNA. In May 2018, Wren Laboratories obtained a California Department of Health permit for NETest®, followed in August 2018 by a New York State Department of Health permit for NETest®. In October 2018, the company developed the PPQ (PRRT Predictive Quotient), a test designed to predict patient response to peptide receptor radionuclide therapy. In August 2019, the laboratory received FDA Emergency Use Authorization for nasopharyngeal swab SARS-CoV-2 diagnosis, and in November 2019 it set up NETesting at Sarah Cannon in the United Kingdom. In October 2020, it received FDA Emergency Use Authorization for COVID-19 PCR saliva testing. In December 2022, the laboratory achieved CAP certification. Development of the PROSTest®, a molecular genomic assay for prostate cancers, began in March 2023. The company completed a PROSTest® clinical validation study in October 2023 and a screening study on high-risk men of African descent for prostate cancer in December 2023. In March 2024, Wren Laboratories completed the publication of the first article about PROSTest® and completed evaluation of PROSTest® as a marker for minimal residual disease (MRD). In May 2024, PROSTest® was approved by CLIA and submitted to NYSDOH. In June 2024, the company was finalizing two clinical studies evaluating PROSTest® as a monitor for 177Lu-PSMA (Pluvicto) radioligand therapy (RLT). In January 2025, NETest 2.0® was developed. In February 2025, ISO15189 certification was submitted. In April 2025, PROSTest® was approved by NYSDOH. In May 2025, NETest 2.0® was submitted to NYSDOH. In September 2025, a large screening study (800 men) for prostate cancer using PROSTest® was conducted. Throughout its history, Wren Laboratories has focused on mRNA liquid biopsy diagnostics, building a portfolio that includes NETest®, NETest PPQ®, and PROSTest® for neuroendocrine and prostate cancers.
- 2025
NETest 2.0® developed.
- 2025
ISO15189 certification submitted.
- 2025
PROSTest® approved by NYSDOH.
- 2025
NETest 2.0® submitted to NYSDOH.
- 2025
PROSTest®: large screening study (800 men) for prostate cancer.
- 2024
Completed the publication of the first article about PROSTest® and completed evaluation of PROSTest® as a marker for minimal residual disease (MRD).
- 2024
PROSTest® approved by CLIA and submitted to NYSDOH.
- 2024
Finalizing two clinical studies evaluating the PROSTest® as a monitor for 177Lu-PSMA (Pluvicto) radioligand therapy (RLT).
- 2023
Development of the PROSTest® – a molecular genomic assay for prostate cancers.
- 2023
Completed PROSTest® clinical validation study.
Products and positioning
Pioneer in mRNA liquid biopsy diagnostics for cancer, offering functional tumor biology insights beyond traditional gene mutation detection.
NETest® 2.0
A simple and rapid blood test for neuroendocrine cancer that can aid in diagnosis, predict tumor progression, predict response to therapeutics, and monitor disease recurrence.
NETest PPQ® 2.0
A test that predicts the likelihood of patient response to peptide receptor radionuclide therapy (PRRT).
PROSTest®
A molecular genomic assay for prostate cancers, used for screening, monitoring, and minimal residual disease detection.
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