Liaison(s): Dan Pankratz, Jonathan Wilde
Veracyte Inc. is a company based in San Francisco founded in 2008 with a vision to transform molecular cytology. The company is committed to enable physicians to improve the quality of patient care and generate savings to the healthcare system. Veracyte develops molecular tests for oncology, for example related to thyroid cancer, that are designed to clarify ambiguous cytology results. According to the American Cancer Society, there are approximately 60,220 new cases of thyroid cancer annually. The diagnoses entail cytopathology of samples obtained via Fine Needle Aspiration (FNA) from the thyroid. It is estimated that 450,000 FNA samples are collected in the United States, of which 100,000 yield indeterminate results and most are referred for thyroid surgery at a cost of $12,000 per procedure. However, approximately 70% of post-surgical pathology tests suggest nodules are actually benign and improperly diagnosed. The Veracyte Afirma® FNA Analysis addresses this unmet need, by enabling these indeterminate results to be re-classified preoperatively, thereby reducing the number of unnecessary surgeries. The Afirma® FNA Analysis combines specialized cytopathology and the novel Afirma® Gene Expression Classifier (GEC) test, which entails microarray based quantification of mRNA extracted from the sample. Both approaches, however, require FNA samples with a sufficient number of thyroid follicular cells, and a sufficient amount of extractable RNA. Inadequate sampling for the cytopathology and Afirma® GEC test occurs in a small number of cases, causing a “no result” to be reported. This often results in a repeat of the FNA procedure, with substantial time delay, negatively impacting the patients. Therefore, it would be ideal for the adequacy of the sample acquisition to be determined immediately at the point-of-care. The Veracyte II TMP team was tasked to investigate technologies that could be used to determine, at the time of FNA sample acquisition, whether a sufficient number of thyroid cells have been collected for the cytopathology and GEC tests. To accomplish this objective, the Veracyte II TMP: is clarifying the requirements for this Sample Adequacy (SA) test; is evaluating the suitability of different biomarkers for FNA SA testing; and, is gathering information on technologies that can appropriately detect these biomarkers with suitable analytical and clinical performance in the targeted use settings. Finally, upon consolidating the data from literature research and feedback obtained from key opinion leaders, the team will recommend the most suitable approaches or combinations of technologies.