Pioneering Molecular Cytology
Veracyte, Inc., based in South San Francisco, Calif., is pioneering the field of molecular cytology to improve patient outcomes and lower healthcare costs. We specifically target diseases that often require invasive procedures for an accurate diagnosis – diseases where many patients undergo costly interventions that ultimately prove unnecessary. We improve the accuracy of diagnosis at an earlier stage of patient care by deriving clinically actionable genomic information from cytology samples collected in an outpatient setting.
Our first commercial solution, the Afirma® Thyroid FNA Analysis, helps reduce unnecessary surgeries and lower healthcare costs as part of thyroid nodule assessment. Afirma centers on the Gene Expression Classifier (GEC), which employs a 142-gene signature to preoperatively determine whether thyroid nodules previously classified by cytopathology as indeterminate can be reclassified as benign for cancer. We have demonstrated the clinical utility and cost effectiveness of the GEC in studies published in peer-reviewed journals and have established the clinical validity of the GEC in a study published in The New England Journal of Medicine in 2012. To date, Afirma has achieved significant physician adoption and has received positive coverage decisions from a range of payers, including Aetna, Humana, Medicare and UnitedHealthcare. Additionally, Veracyte has entered into a global co-promotion agreement with Genzyme Corporation, a subsidiary of Sanofi.
We believe molecular cytology has the potential to improve patient care while simultaneously lowering costs to the healthcare system in a broad range of areas. We are currently embarking on additional genomic tests that will be incorporated into our comprehensive Afirma Thyroid FNA Analysis, further improving clinical patient management. Additonally, we are in late biomarker discovery in interstitial lung disease (ILD), a group of lung diseases that are difficult to diagnose prior to surgery. We also have early biomarker discovery efforts underway to help resolve the diagnosis of nodules found on imaging modalities that are suspicious for cancer.