Clinical Programs

Driving Clinical Advancements

Veracyte uses rigorous, large, prospective, double-blind, multicenter clinical studies. Studies are conducted in both academic and community sites, for clinical validation, as well as discovery.

Our first molecular test — branded the Afirma Gene Expression Classifier — targets thyroid and is designed to improve the diagnostic accuracy of thyroid nodule FNA samples, potentially helping thousands of patients each year avoid surgery.⁵ Veracyte plans to bring additional molecular cytology tests to market, leveraging its rigorous scientific and clinical platforms to similarly address unmet clinical needs. The company is currently in the early biomarker discovery phase for lung cancer and interstitial lung diseases (which affect the tissue and space around the lung’s air sacs).

Relevant Statistics

The following statistics underscore the increased need for diagnostic clarity.

Thyroid Cancer

An estimated 450,000 thyroid biopsies are performed each year in the U.S., yet only 56,460 new cases of thyroid cancer are expected to be diagnosed in 2012.^1,2
An estimated 100,000 patients every year are recommended for surgery on nodules that ultimately prove to be benign.¹

Lung Cancer and Interstitial Lung Diseases

An estimated 221,130 new cases of lung cancer are expected to be diagnosed in the U.S. in 2011, and an estimated 200,000 patients are expected to present each year with difficult-to-diagnose interstitial lung disease.^2,3
In each suspected disease area, Veracyte estimates that every year, tens of thousands of patients with ambiguous cytology results are sent to surgery only to receive a benign diagnosis.
New lung cancer screening guidelines now recommend routine CT scans for approximately 7 million high-risk individuals, which is expected to uncover a high percentage of benign nodules that could benefit from improved cytology assessment.⁴

1. Li H, Robinson KA, Anton B, Sadhanha IJ, Ladenson PW. Cost-effectiveness of a novel molecular test for cytologically indeterminate thyroid nodules. (published online ahead of print Aug 24, 2011). J Clin Endocrinol Metab. 2011.

2. American Cancer Society. Cancer Facts & Figures 2012. Atlanta: American Cancer Society; 2012

3. Raghu G, Weycker D, Edelsberg J, Bradford W, Oster G. Incidence and prevalence of Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2006;174:810-816, and Veracyte internal estimates.