Portfolio and test expansion

Leading-edge cancer diagnostics

Veracyte’s novel tests empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our high-performing tests enable clinicians to make more confident diagnostic, prognostic, and treatment decisions for some of the most challenging diseases. Our proprietary framework enables us to identify a specific clinical unmet need and create the test to address that need. We then develop the clinical evidence, reimbursement, and clinical guideline inclusion to support market adoption in the US and beyond.

We expand our test portfolio in three ways

1

Extend our current tests to answer additional clinical questions

By constantly listening to the clinicians we serve, we are able to identify additional clinical questions that we can answer to help them provide even better care for their patients. We seek to develop solutions that will complement our current offerings and will be easy for clinicians to use.

2

Create in vitro diagnostic (IVD) versions of our CLIA tests for global expansion

Following the development of robust clinical evidence and clinician adoption of our CLIA tests in the US, we then focus on making them available to more patients worldwide. We do this by creating IVD versions of our tests so that labs in Europe and beyond can perform them locally.

3

Develop new tests to address unmet needs

We collaborate closely with clinicians to identify unmet patient-care needs that we can address with novel solutions. We focus on identifying specific points in the patient care continuum where providing clinicians with more accurate and comprehensive information can help them better guide next steps for their patients.

Veracyte’s tests and availability

Scroll right to view full test and disease table below:

Commercially available
In development
Product Disease area Description US (CLIA) | Outside the US (IVD)
Afirma® Genomic Sequencing Classifier
Thyroid cancer

Helps reduce unnecessary surgeries and inform treatment decisions.
Afirma Extension
DNA TERT Analysis

Determines TERT promoter gene mutation status to help further personalize diagnosis and treatment for patients with thyroid nodules that are suspicious for cancer.
Decipher® Prostate Genomic Classifier
Prostate cancer

Helps inform treatment decisions for men with localized prostate cancer.
(2024+) †
Decipher Extension
Advanced and Metastatic Tumors

Intended to expand Decipher Prostate Genomic Classifier’s coverage to advanced and metastatic prostate tumors.
Prosigna® Breast Cancer Assay
Breast cancer

Informs treatment decisions for women with early-stage breast cancer.
‡
Envisia® Genomic Classifier
Interstitial lung disease (ILD)

Detects a genomic usual interstitial pneumonia (UIP) pattern to increase confidence in ILD diagnosis and prognosis.
(2022+) †
Decipher® Bladder Genomic Classifier
Bladder cancer

Reveals cancer molecular subtype to help inform treatment decisions for patients with bladder cancer.
Percepta® Nasal Swab Test
Lung cancer

Uses a simple, non-invasive nasal brushing to objectively assess cancer risk in lung nodules found on computed tomography (CT) scans.
(2025+) †
Lymphmark™
Diffuse large B-cell lymphoma

Lymphoma subtyping test being developed as a companion diagnostic for Acerta Pharma and AstraZeneca’s acalabrutinib (Calquence®).
‡
Decipher® Kidney Genomic Classifier
Kidney cancer

Genomic test being developed to inform treatment decisions for patients with kidney cancer.

* All Afirma tests are performed in our US-based CLIA labs. Tests may be available outside the US in select instances.
† Expected date of submission for CE-mark consideration
‡ IVD format in US
§ Date submitted for CE-mark consideration

A collection of test samples on a tray.

BETTER DATA FOR BETTER INSIGHTS

New Veracyte tests in development

Veracyte is developing new tests to enable physicians to provide better cancer care at pivotal moments for patients. Our tests use pioneering science to address unmet needs and enable us to help further improve patient care globally.

Percepta® Nasal Swab test for lung cancer diagnosis

Veracyte’s Percepta Nasal Swab test is a simple, noninvasive tool designed to assess lung cancer risk in patients with lung nodules found on CT scans. The novel test has been shown to identify with high accuracy which patients with lung nodules are low risk for cancer so that they may potentially avoid unnecessary invasive procedures, and which patients are high risk so that they may proceed to further diagnostic workup and appropriate treatment, if needed.1,2 The test evaluates genomic changes associated with lung cancer that can be found in the nasal passages of current and former smokers.2 The Percepta Nasal Swab is currently available to hospitals and clinics that are participating in Veracyte’s NIGHTINGALE trial to assess the impact of its use on patient care.

Veracyte Lung website

Decipher® Prostate test for advanced and metastatic tumors

The Decipher Prostate Genomic Classifier currently provides actionable information to inform treatment decisions across the spectrum of localized prostate cancer. Though patients with localized cancer account for a majority of the 288,300 patients expected to be diagnosed with prostate cancer in 2023, there has been an annual increase in regional-stage and distant-stage diagnoses since 2011.3,4 Recent data highlights the opportunity for Decipher Prostate to provide additional information for people with advanced prostate cancer. Veracyte continues to collaborate with leading researchers to further substantiate that the Decipher Prostate test can identify men with advanced and metastatic cancer who are more likely to benefit from intensified treatment.5-8

 

Lymphmark™

Lymphmark is a molecular subtyping test being developed as a companion diagnostic to identify patients with untreated diffuse large B-cell lymphoma (DLBCL) who may benefit from Acerta and AstraZeneca’s acalabrutinib (Calquence®) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy. The test is currently being used to help inform patient selection for the Phase 3 ESCALADE trial. The randomized, double-blind, placebo-controlled ESCALADE study is designed to evaluate the efficacy and safety of acalabrutinib with R-CHOP therapy as compared to placebo plus R-CHOP in patients aged 18 to 65.

Veracyte lab with an employee at work at a computer.
A lab worker examines a label on a vial.

Learn about our US labs and global expansion

Enabling global access

REFERENCES

  1. Lamb C. Oral presentation at CHEST Annual Meeting. October 2021. Virtual format.

  2. Perez-Rogers JF, et al. J Nat Cancer Inst. 2017.

  3. Cancer Facts & Figures 2023. American Cancer Society. 2023.

  4. Siegel, R, et al. Cancer Statistics, 2023. CA Cancer J Clin. 2023.

  5. Hamid A, et al. Ann Oncol. 2021.

  6. Feng F, et al. JAMA Oncol. 2021.

  7. Feng F, et al. J Clin Onc. 2020.

  8. Attard G, et al. Res Sq [Preprint]. 2023.

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