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Singlera Genomics Inc.

Singlera Genomics Inc. is a La Jolla-based company established in 2014 that develops liquid biopsy and molecular diagnostic solutions for early cancer detection.

Last updated September 16, 2026

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Overview

Singlera Genomics Inc. is a company in La Jolla, United States, established in 2014. It describes itself as a leader in cancer early screening and molecular diagnostics, specializing in methylation detection for risk assessment, early screening, medication guidance, and recurrence monitoring of high-incidence cancers. Its product and solution range covers cancer early screening, diagnosis, and prognostic monitoring for cancers such as lung cancer, colorectal cancer (ColonAiQ), liver cancer (HepaAiQ), gastric cancer, esophageal cancer, pancreatic cancer (PDACatch), and thyroid cancer. Its PDACatch assay has been granted FDA Breakthrough Device Designation for early detection of pancreatic adenocarcinoma in high-risk individuals, and is used by BREAKTHROUGH GENOMICS in the BT-Reveal Early Pancreatic Cancer Test. The company also lists locations in Chengdu, Taizhou, Shanghai, and Yangzhou in China, and names partners including Element Biosciences, Clinomics, Xiang Ya Hospital, Astellas, Fudan Taizou Institute, Astrazeneca, and University of California SD.

History

Singlera Genomics Inc. was established in 2014. It is a company in La Jolla, United States. The company describes itself as a leader in cancer early screening and molecular diagnostics since 2014, focusing on early cancer detection through advanced molecular diagnostic technology. It offers solutions for tumor and genetic disease detection, specializing in methylation detection for risk assessment, early screening, medication guidance, and recurrence monitoring of high-incidence cancers. Its PDACatch assay has been granted FDA Breakthrough Device Designation for early detection of pancreatic adenocarcinoma in high-risk individuals, and in April 2023 the BT-Reveal Early Pancreatic Cancer Test, offered by BREAKTHROUGH GENOMICS in partnership with Singlera Genomics as technology partner, was designated as a Breakthrough Device by the FDA.

Products and positioning

Leader in cancer early screening and molecular diagnostics, specializing in methylation detection for high-incidence cancers.

  • PDACatch

    A liquid biopsy assay granted FDA Breakthrough Device Designation for the early detection of pancreatic adenocarcinoma (PDAC) in high-risk individuals, utilizing proprietary DNA methylation technology to identify circulating tumor DNA.

  • ColonAiQ

    A product for colorectal cancer within Singlera's cancer early screening, diagnosis, and prognostic monitoring range.

  • HepaAiQ

    A product for liver cancer within Singlera's cancer early screening, diagnosis, and prognostic monitoring range.

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