Veracyte Inc.

Company Overview

Veracyte Inc., founded in 2006, is developing and commercializing molecular diagnostics.

Veracyte’s products include: Afirma Genomic Sequencing Classifier and Xpression Atlas (includes the Afirma GSC and Xpression Atlas), Percepta Bronchial Genomic Classifier (improves lung cancer diagnosis by improving the performance of diagnostic bronchoscopies), Envisia Genomic Classifier (improves diagnosis of idiopathic pulmonary fibrosis) and Prosigna Breast Cancer Prognostic Gene Signature Assay (uses genomic technology to inform next steps for patients with early-stage breast cancer, based on the genomic make-up of their disease).

The Afirma Thyroid FNA Analysis test helps physicians to reduce unnecessary diagnostic surgeries for patients with thyroid nodules.

Veracyte is developing Afirma Malignant GEC test, which is designed for endocrinologists, radiologists, and head and neck specialists.

Veracyte has the following alliances: Johnson & Johnson (to advance the development and commercialization of diagnostic tests to detect lung cancer are an early stage) and Loxo Oncology (therapies for patients with genetically defined cancers).

In December 2019, Veracyte exclusively licensed NanoString Technology’s nCounter Flex platform for diagnostic use and obtained the rights to NanoString’s 510(i)-cleared Prosigna breast cancer prognostic test and research use-only LymphMark lymphoma subtyping assay. Veracyte planned to market the Prosigna assay as both a kit and through its U.S. CLIA laboratory. It will also sell future diagnostic tests developed for the nCounter platform and distribute the nCounter Flex system for diagnostic purposes. Veracyte planned to transition its current diagnostic and prognostic cancer assays onto the nCounter platform so as to reach a wider global audience.

This agreement provided Veracyte more access to international markets for its tests and expanded its testing menu. Veracyte is planning to launch its Envisia classifier for idiopathic pulmonary fibrosis diagnosis to customers outside the U.S. as a kit-based test on the nCounter system.

In February 2021, Veracyte acquired Decipher Biosciences, a developer of urologic cancer tests. This acquisition helped Veracyte expand its global footprint into the cancer diagnostics market with its nCounter platform. Decipher will remain a wholly owned subsidiary of Veracyte, which plans to integrate Decipher’s urologic cancer tests onto its nCounter platform.

Financial Highlights (FY 2024)

Company's Business Segments

• Testing revenue : Under this segment, the company provides bills for testing services upon completion of tests and delivery of a patient report to the prescribing physician.
• Product revenue : This segment consists primarily of sales of the Prosigna breast cancer assay and related diagnostic kits and services.
• Biopharmaceutical and other revenue : The company licenses and provides access to its assets and services to third parties, including clinical and testing services, research and development, contract manufacturing and development, and other services.